Cheryl Barton is director of PharmaVision, 

Cheryl Barton

Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com

On 14 Apr. 2025, the European Medicines Agency (EMA) published strategic recommendations designed to strengthen the supply chain of radiopharmaceuticals (1). In the recommendations, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) highlighted key areas of vulnerability and proposed measures to mitigate the impact of shortages in the European Union (EU).

Radiopharmaceuticals are specialised drugs that contain radioactive isotopes and are used primarily in nuclear medicine. The production and distribution of radiopharmaceuticals involves several critical processes that must adhere to stringent regulatory guidelines to ensure the safety and efficacy of these products (2). As of 2024, all radiopharmaceutical products are considered medicines in the EU, and industrially prepared products must be authorized as pharmaceuticals (3). However, country-level regulation is diverse, and the different regulatory and Health Technology Assessment (HTA) systems have led to significant differences in the use and availability of radiopharmaceuticals across the EU (4–5).

Demand for radiopharmaceuticals increasing

Radiopharmaceuticals play important roles in medical imaging, diagnosis, and treatment. Several radiopharmaceuticals have received regulatory approval for therapeutic use, and many more are in clinical development (

). The global radiopharmaceutical market is estimated to be worth US$6.97 billion in 2024 and is forecast to reach US$11.06 billion by 2034, as market demand increases and innovative agents reach the market (6).

 Regulatory-approved radiopharmaceuticals for therapeutic use. Modified from KPMG. Leveraging Opportunities in Radiopharmaceuticals. Kpmg.com. 21 Mar. 2025.

Whilst the demand for radiopharmaceuticals is steadily increasing, the manufacturing capacity in Europe is limited, and many research reactors are ageing (8).

Manufacture of radiopharmaceuticals is complex

The production of radiopharmaceuticals relies on stable isotopes and other materials, which are mainly sourced from China, Russia, and other geopolitically sensitive areas (9). Importantly, high-assay-low-enriched uranium (HALEU), used as fuel for research reactors, is currently not produced in the EU and can only be imported from Russia or the United States. Additionally, the supply chain of these medicines, including how to transport them safely, is complex (1).

Most radiopharmaceuticals used for diagnostic purposes are produced at the time of use because they begin to decay the moment they are made (10). Manufacturers are unable to stockpile radioisotopes, which means that small fluctuations in the global supply of some isotopes can have a significant impact on manufacturing. As a result, strong supplier relationships and risk-based plans for transporting raw materials and finished radiopharmaceuticals are essential (10).

Large pharma companies, such as Bayer AG, Bracco Imaging, Cardinal Health, Curium Pharma, Eli Lilly, Lantheus Holdings, Novartis AG, and Nordion, provide radiopharmaceuticals to healthcare facilities that include hospitals, ambulatory surgical centres, clinics, and specialty hospitals (6). Companies are forming partnerships with contract development and manufacturing organisations (CDMOs) and other manufacturers to expand their reach and ensure a reliable supply chain.

MSSG recommendations for radiopharmaceuticals

To mitigate supply chain issues, the MSSG recommends:

enhancing domestic production capabilities, including the development of EU-based HALEU enrichment and metallization facilities

continuation and expansion of the European Radioisotope Valley Initiative (ERVI), alongside optimizing existing production installations

harmonization of transport procedures and extended monitoring to additional radioisotopes, ensuring preparedness for rising demand

diversifying sources of key materials to reduce geopolitical risks

investing in modernizing and expanding EU-based production facilities

enhancing collaborative efforts among Member States for coordinated responses (1, 11).

The MSSG has provided specific recommendations and invited EU Member States to assess national supply chains, address transport issues, include new radiopharmaceuticals in horizon scanning activities, and provide regulatory support (12). The recommendations also encourage EMA to offer regulatory support, assist Member States with horizon scanning, and coordinate related activities to ensure efficiency and avoid duplication of efforts (12). All stakeholders are invited to cooperate and share relevant information to help secure the EU supply of medical radioisotopes.

The ERVI is reviewing the EU's production capacity for metallic HALEU. It is also looking at ways to enhance the production of enriched stable isotopes, strengthen medical radionuclide production, expand the European medical radionuclide programme, and develop more reliable monitoring of supply and demand (1).

The Euratom Supply Agency (ESA) is responsible for securing the supply of source materials for radioisotopes production and is involved in theStrategic Agenda for Medical Ionising Radiation Applications, or SAMIRA. This is a comprehensive action plan to support safe, high-quality, and reliable use of radiological and nuclear technology in healthcare (13). ESA also monitors the production chain of medical radioisotopes through the European Observatory on the Supply of Medical Radioisotopes.

Given the increasing demand for isotopes and the geopolitical uncertainties surrounding supply, diversification is essential (9). The European Association of Nuclear Medicine welcomed the EMA's recommendations and was “pleased to see such a political commitment to the supply of medical radioisotopes at the highest level. As the demand for radiopharmaceuticals grows, ensuring their consistent availability is paramount for patient care across Europe” (12).

The European Parliament has already been proactive in addressing supply chain issues associated with the production of APIs and finished medicines (14), and it is now up to the MSSG to align radiopharmaceutical supplies with the EU demands through the Medicine Shortages Single Point of Contact Working Party (15).

Efforts are underway in Europe to expand stable isotope enrichment capabilities outside of Russia to help reduce dependency and enhance long-term security. In addition, new technologies are emerging that may provide alternative approaches to reactor-based production, and the construction of new research reactors, such as the PALLAS reactor in the Netherlands, will expand capacity for medical isotope production (9). However, legislative changes, such as the implementation of the Critical Medicines Act, are essential to minimize the risk of medicine shortages and safeguard the health of EU citizens moving forward (16).

Tackling Vulnerabilities in the Supply Chain of Radiopharmaceuticals in the EU

Regulatory Radiopharmaceutical Production.

Radiopharmaceuticals Landscape in Europe: Commercial and In-House Production

Radiopharmaceutical Small-scale Preparation in Europe: Will We Be Able to Harmonize the Situation

The Regulatory Landscape of Radiopharmaceuticals: Ensuring Safety and Effectiveness

Leveraging Opportunities in Radiopharmaceuticals

EMA: Recommendations Regarding Vulnerabilities in the Supply Chain of Radiopharmaceuticals

The Geopolitical Tightrope of Medical Isotope Supply: Risks and Opportunities

. LinkedIn Post. LinkedIn.com. 19 Feb. 2025

Radiopharmaceuticals: A Guide for Manufacturers

EU Takes Action to Secure Radiopharmaceutical Supply Chains

EMA’s Recommendations to Address Vulnerabilities in the Supply Chain of Radiopharmaceuticals

. euratom-supply.ec.europa.eu/ (accessed May 2025).

Overreliance on Imports of Active Pharmaceutical Ingredients

Medicine Shortages Single Point of Contact (SPOC) Working Party

Cheryl Barton is founder and director of PharmaVision, Pharmavision.co.uk.

Articles

EMA has published recommendations to address potential radiopharmaceutical shortages.

EMA Is Tackling Vulnerabilities in the Supply Chain of Radiopharmaceuticals

On 29 Jan. 2025, the European Parliament (EP) held a public hearing to discuss ways to support the production of APIs and finished medicines within Europe (1). The European Union (EU) faces a growing challenge in securing its supply of essential pharmaceuticals, with the majority of its APIs and finished medicines currently imported from Asia, namely India and China.

This article was published in the May 2025 issue of 

APIs play a pivotal role in the pharmaceutical industry. They are essential for the efficacy and safety of drugs. The quality of APIs directly impacts the effectiveness of the final drug product (2). Whilst the globalization of the medicines supply chain has helped to increase access to cheap, high-quality medicines, the supply chain has grown longer, more complex, and fragmented, and countries have become more reliant on overseas API suppliers (2).

The European API sector is considered highly competitive, given its technical know-how and strong workforce capacities (3). API manufacturing is an important sector, generating €60 billion per year and employing more than 150,000 people throughout Europe (3). Over the past two decades, Europe’s API manufacturing capabilities have decreased from 42% share of the market in API Drug Master Files (DMFs) in 2000 to 10% in 2023, highlighting the long-term trend of decreasing API manufacturing activity within Europe (

). There has also been a shift of small-molecule APIs and related intermediates production towards Asia, and more than 74% of the European medicine value chain depends on imports (

Figure 1: Active API Drug Master Files by region, 2000, 2023. Figure courtesy of the author

Whilst India remains the market leader in API manufacturing, China has exhibited strong growth and expanded its role in global API production, accounting for almost one-third of all DMF filings in 2023 (4). These findings underscore the importance of monitoring the pharmaceutical supply chain to understand and adapt to market dynamics and reduce any perceived threats that the EU’s reliance on API imports may have on public health in the Member States.

Figure 2: European supply chain (base 100, 2023). Figure courtesy of the author.

Reshoring pharmaceutical production in Europe and promoting geographic diversity in API manufacturing will help reduce supply chain vulnerabilities and the risk of drug shortages (5). This was the conclusion of the Environment, Public Health and Food Safety report, Potential Measures to Facilitate the Production of Active Pharmaceutical Ingredients (APIs), published in March 2023 (5). The study confirmed that reshoring would require financial support from governments to the pharmaceutical industry, but this was not the only factor. Further solutions were proposed including agreements with local chemical suppliers (e.g., key materials), the consideration of fee or tax benefits, the development of new production technologies to accelerate automation and reduce labour costs, incentives to encourage the use of environmentally friendly technologies, the creation of training and programmes to develop workforce needs, and the alignment of existing policies (6).

On 11 Mar. 2025, the European Commission (EC) took the first step in this direction and proposed the Critical Medicines Act, setting out a plan to improve medicine procurement, provide subsidies for drug production, and improve supply chains to reduce the risk of drug shortages (7). But time is running out.

The EU needs to move quickly or risk a manufacturing exodus to the US

In April 2025, the European Federation of Pharmaceutical Industries and Associations issued a stark warning that “unless Europe delivers rapid, radical policy change, then pharma research, development, and manufacturing is increasingly likely to be directed towards the [United States]” (8). The CEOs of the research-based pharmaceutical industry called for immediate action on:

adopting a world-leading regulatory framework conducive to innovation

achieving a competitive EU market that attracts, values, and rewards innovation in line with other economies at the forefront of patient care

ensuring policy coherence across environmental and chemical legislation to secure a resilient manufacturing and supply chain of medicines in Europe

strengthening rather than weakening Europe’s intellectual property provisions (8).

In the meantime, the uncertainty created by the threat of US tariffs on pharmaceuticals means there are limited incentives for pharma to invest in the EU and a significant push to relocate to the US. In the past month, several pharmaceutical companies—Eli Lilly, Johnson & Johnson, Merck, Novo Nordisk, and Novartis—have announced their plans to expand manufacturing facilities in the US (9). Whilst it may take several years for these sites to become fully operational, it sends a clear message that market dynamics have changed, and the EU will need to move quickly and invest in its pharmaceutical ecosystem, or it will fall behind and be held to ransom by overseas suppliers (8).

EP. Overreliance on Imports of Active Pharmaceutical Ingredients. Committee of Public Health. 29 Jan. 2025.

SEQENS. Enhancing Drug Development: A Comprehensive Guide to API Manufacturing. Seqens.com. 17 Jan. 2025. (accessed 15 Apr. 2025).

Medicines for Europe. EP Hearing on “Overreliance on imports of Active Pharmaceutical Ingredients (APIs)”. Committee for Public Health (SANT) European Parliament. 25 Jan 2025.

Quality Matters. Global Manufacturing Capacity for Active Pharmaceutical Ingredients Remains Concentrated. U.S. Pharmacopeia Blog. 6 Nov. 2024

CHESSMEN. Identifying the Root Causes of Observed Shortages of Medicines. 2024. Ja-chessmen.eu (accessed 16 April 2025).

ENVI. Potential Measures to Facilitate the Production of Active Pharmaceutical Ingredients (APIs). March 2023.

EC. Proposal for a Critical Medicines Act. EC.europa.eu. 11 Mar. 2025

EFPIA. Pharma CEOs Alert President von der Leyen to Risk of Exodus to the US. Efpia.eu. 8 Apr. 2025.

POLITICO. Trump Says Pharma Tariffs Will Entice Back Drug Production. They Won’t. Politico.eu. 14 Mar. 2025.

When referring to this article, please cite it as Barton, C. EU to Support the Production of APIs and Finished Medicines within Europe. 

The European Union is discussing ways to reduce Europe’s over-reliance on imports of APIs.

EU to Support the Production of APIs and Finished Medicines within Europe  

Advancing Healthcare with CAR T-Cell Therapy: A New Frontier in Medicine | Image Credit: ©Funny – stock.adobe.com

In the past two decades, significant advances in immunology have improved our understanding of immune checkpoint mechanisms and the role of T-cell receptors (TCRs) recognizing tumour antigens and tumour cell eradication (1). This knowledge has led to the development of several immune checkpoint inhibitors (ICIs) such as anti-programmed cell death protein 1 (PD-1) and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) treatments. Although ICIs have cured many cancer patients, some patients fail to respond to ICIs due to the limited presence of tumour-specific effector T cells (2).

This article was published in the April 2025 issue of 

Adoptive T-cell therapies (ACTs), which include chimeric antigen receptor T cells (CAR-T), tumour-infiltrating lymphocytes (TILs), and engineered T-cell receptor-T cells (TCR-Ts), have the potential to overcome these shortfalls. To date, six CAR-T therapies targeting CD19 or B cell maturation antigen have been approved by the regulators and have shown encouraging results in haematological cancers; however, their clinical impact on solid tumours has been modest due to antigen scarcity, tumour heterogeneity, and immunosuppression within the tumour microenvironment (TME) (3–4). Thus, companies have been exploring other ACT approaches to overcome these issues (5–6).

Engineered T-cell receptor-T cell therapies

TCR-T increases the flexibility for targeting solid tumours, particularly those with a high mutational burden (HMB). Unlike TILs, one does not need access to the primary tumour, which allows the use of upstream sources of material, for example, peripheral blood. Importantly, TCR-T cells can target inside the cell surface and recognize a broader range of epitopes than CAR-T cells and up to 90% of cellular proteins, including:

tumour-associated antigens (TAAs) that are over-expressed in cancer cells compared with normal tissues. For example, tissue differentiation antigens (TDAs) such as melanoma antigen recognized by T 1 (MART-1) and gp100, and cancer germline antigens (CGAs) such as melanoma-associated antigen A (MAGE-A) protein family, New York oesophageal squamous cell carcinoma-1 (NY-ESO-1), and preferentially expressed antigen in melanoma (PRAME)

tumour-specific antigens (TSAs) or neoantigens (NAs) that are exclusively expressed in tumour cells. For example, TP53 and Kirsten rat sarcoma virus (KRAS)

viral antigens, for instance, antigens stemming from viral-induced cancers such as Epstein-Barr virus (EBV), human papillomavirus (HPV), hepatitis B virus (HBV), and Merkel cell polyomavirus (MCPyV).

Importantly, TCR-T cells exhibit high antigen sensitivity that could result in improved tumour cell detection and removal, and they are associated with a high level of T cell persistence (7). More than 30 clinical trials are underway exploring the potential of TCR-T cells in haematological and solid tumours (

Table I. TCR-T cell therapies in clinical development.

Allogeneic “off-the-shelf” solutions are emerging

The use of gene editing in autologous (patient-derived) CAR-T and TCR-T cell therapies is dictated by the compatibility of the highly polymorphic HLA molecules between donors and recipients, which can lead to graft-versus-host disease (GVHD) and rejection. Academic researchers and biotechs are looking at ways to generate “off-the-shelf” or allogeneic (universal) solutions using virus-specific T cells, lipid-restricted (CD1) T cells, MR1-restricted T cells, and γδ-TCR T cells (8). This approach could enable TCR-T therapies to be produced more cost-effectively and be made available to a broader patient population. For instance, researchers at Princess Máxima Center for Paediatric Oncology, Utrecht, The Netherlands, have engineered allogeneic cord blood-derived CD8+ T cells with a specific TCR targeting the tumour-associated antigen WT1 to achieve high efficiency and potent cytotoxicity against AML cells (9).

European biotech investing in TCR-T therapies

Several European biotechs are leading the way in TCR-T therapies, including the following.

 The biopharma company was co-founded by CEO Reagan Jarvis in 2014 to develop TCR-T therapies to treat solid tumours and other difficult-to-treat diseases, including infectious and autoimmune diseases. Its proprietary TCR discovery platform systematically maps cancer targets to build TCR libraries and generate personalized TCR-T treatments. To date, the company has raised US$120 million (€111 million) in three funding rounds, attracting investment from AMF, Danske Bank, European Investment Bank, Melby Gard, and others (10). In May 2024, Anocca teamed up with Shinobi Therapeutics to co-develop “off-the-shelf” allogeneic TCR-induced pluripotent stem cell (iPS)-T-cell therapies for the treatment of solid tumours (11). In March 2025, Anocca received authorization for its Clinical Trial Application (CTA) to initiate a Phase I/II, VIDAR-1 trial with ANOC-001, a non-viral gene-edited TCR-T therapy targeting mutant KRAS G12V in advanced pancreatic cancer. Anocca aims to initiate the study in the second quarter of 2025 and enrol 20 patients with HLA and KRAS mutations at leading medical centres in Sweden, Denmark, Germany, and the Netherlands (12).

 Immunocore was founded by Bent Jakobsen and James Noble in 2008 as a spinout of MediGene AG. The core TCR technology was developed at Oxford University in 1999. The company has raised more than US$574 million (€531 million) and undertook an IPO in February 2021. Immunocore’s proprietary TCR technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) that enable the immune system to recognize and eliminate virally infected cells. ImmTACs recognize intracellular cancer antigens and selectively kill haematological and solid tumour cells via an anti-CD3 immune-activating effector function. In January 2022, the US Food and Drug Administration (FDA) approved Kimmtrak (tebentafusp), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for the treatment of metastatic uveal melanoma (13). Kimmtrak generated global sales of US $310 million (€280 million) in 2024. Tebentafusp is currently being evaluated in two Phase III trials (TEBE-AM and ATOM) in additional melanoma indications. Immunocore is evaluating brenetafusp (IMC-F106C) targeting PRAME-A02 in the Phase III PRISM-MEL-301 in first-line advanced cutaneous melanoma and a Phase I/II trial of brenetafusp combinations in ovarian cancer and NSCLC. In addition, the company is evaluating an IMC-P115C targeting PRAME-A02-HLE in a Phase I trial for colorectal and other gastrointestinal cancers (14). The company is also evaluating the ImmTAC technology in infectious diseases (HIV and HBV) and autoimmune diseases (type 1 diabetes and dermatology) (15).

 Medigene is an immuno-oncology platform company developing TCR-T therapies. Its End-to-End Platform aims to generate and optimize TCRs for multiple therapeutic modalities, including TCR-guided T cell engager therapies (TCR-TCEs), TCR-natural killer (TCR-NK) cell therapies, and TCR-T cell therapies. The company has codeveloped an allogeneic TCR-TCE therapy, MDG3010, with WuXi Biologics that targets KRAS G12V in solid tumours. It is also developing autologous TCR-T therapies, including MDG1015 (NY-ESO01/LAGE-1a), MDG2011 (KRAS G12V), MGD2021 (KRAS G12D), and MDG2012 (KRAS G12V) (16). Medigene has forged partnerships with BioNTech and Regeneron where it is codeveloping a PRAME TCR-T and MAGE-A4 TCR-T therapy, respectively (17). In February 2025, the company partnered with EpimAb Biotherapeutics to develop MCD3020, an allogeneic TCR-TCE for the treatment of solid tumours and immune-related disorders (18).

Biotechs in the US and the Asian Pacific are active in the TCR-T space

In the United States, Adaptimmune Therapeutics and Iovance Biotherapeutics have received regulatory approval for ACTs. In March 2024, FDA approved Iovance’s Amtagvi (lifileucel), the first TIL therapy for advanced melanoma following anti-PD1 and targeted therapy (19). In clinical studies, the overall response rate for pooled data in 153 patients was 31.4%, the median duration of response (mDOR) was 21.5 months, and the four-year pooled analysis mDOR was not reached at 48.1 months. In August 2024, FDA approved Adaptimmune’s Tecelra (afamitresgene autoleucel), the first MAGE-A4-targeted TCR-T therapy for unresectable or metastatic synovial sarcoma (20). Among the 44 patients in the trial who received Tecelra, the overall response rate was 43.2%, and the median duration of response was six months.

Several other US biotech companies are evaluating TCR-T therapies in the clinic, including BioNTech, Cartesian Therapeutics, Immatics, and Regeneron. Immatics has developed three proprietary platforms: an autologous ACTengine, an allogeneic ACTallo platform, and an antibody-like TCR bispecific platform or T cell engaging receptors (TCER). Its lead programme, IMA203, uses ACTengine technology and is currently being evaluated in the Phase III SUPRAME targeting PRAME in heavily pretreated metastatic melanoma patients (21).

In January 2025, BioNTech published proof-of-concept data from Phase I trials with BNT221, a personalised, neoantigen-specific autologous T-cell product derived from peripheral blood (22). The infused T cells were highly specific, polyfunctional, and cytotoxic and expressed TCRs with a wide range of avidities in patients with advanced melanoma. The treatment was well-tolerated, and the vast majority of adverse events observed were attributed to the lymphodepletion chemotherapy preceding BNT221 infusion.

Other US biotechs working in this field include Alaunos Therapeutics, Affini-T Therapeutics, BlueSphere Bio, and TScan Therapeutics.

In the Asian-Pacific region, HRYZ Biotech, Neowise Biotechnology, Precision Biotech, and TCRCure Biological Technology in China; Lion TCR and SCG Cell Therapy in Singapore; and Takara Bio in Japan all have products in early clinical development.

Advances in TCR-T applications and the clinical approval of novel ACTs have paved the way for a new generation of T-cell therapies targeting solid tumours (23). Despite the promising clinical results, the total time to manufacture the cell product still limits the broader use of ACT therapies. Like CAR-T therapies, TCR-T cell therapy requires cellular expansion; however, the CAR-T field is moving towards in-vivo approaches. Further work is needed to enhance the potency, expansion, and persistence of T-cells; this may be achieved by combining products such as PD-1 inhibitors/TCR-T or cancer vaccine/TCR-T therapy (24).

Alternatively, the development of allogeneic TCR-T therapies could provide a cost-effective “off-the-shelf” solution, enabling patients broader access to these innovative therapies. Several large pharma companies, AstraZeneca, Galapagos, GlaxoSmithKline, and Shionogi, have TCR-T programmes in clinical development, and this field is likely to attract further investment from biopharma and private investors as proof-of-concept studies report out.

Zhao, X.; Shao, S.; Hu, L. The Recent Advancement of TCR-T Cell Therapies for Cancer Treatment. 

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Rosenberg, S. A. and Restifo, N. P. Adoptive Cell Transfer as Personalized Immunotherapy for Human Cancer. 

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Waldman, A. D.; Fritz, J. M.; Lenardo, M. J. A Guide to Cancer Immunotherapy: From T cell Basic Science to Clinical Practice. 

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Schendel, D. J. Evolution by Innovation as a Driving Force to Improve TCR-T Therapies. 

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Lo Presti V.; Meringa, A.; Dunnebach, E.; et al. Combining CRISPR-Cas9 and TCR Exchange to Generate a Safe and Efficient Cord Blood-Derived T Cell Product for Pediatric Relapsed AML. J

, 12 (4). DOI.org/10.1136/jitc-2023-008174

Tracxn. Anocca - Raised $120M in Funding from 8 Investors. 

Anocca. Anocca AB and Shinobi Therapeutics Announce Strategic Partnership to Develop Allogeneic TCR-T Cell Therapies in Oncology. Press Release. 30 May 2025.

Anocca. Anocca Announces Authorisation of Clinical Trial Application to Start First In-Human Trial in Advanced Pancreatic Cancer. Press Release. 17 Mar. 2025.

OncoDaily. KIMMTRAK (Tebentafusp) Uses in Cancer: Dosages, Indications, Expectations and More. 23 Feb. 2025.

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FDA. FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma. Press Release. 16 Feb.2024.

FDA. FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma. Press Release 2 Aug. 2024.

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When referring to this article, please cite it as Barton, C. Engineered T Cell Receptor-T Cell Therapies. 

New TCR-T cell therapies look promising in the treatment of haematological and solid tumours.

Engineered T Cell Receptor-T Cell Therapies

On 11 Mar. 2025, the European Commission (EC) proposed the Critical Medicines Act, setting out a plan to improve medicine procurement, provide subsidies for drug production, and improve supply chains to reduce the risk of drug shortages (1). The European Union (EU) relies heavily on medical supplies outside the EU, particularly India and China (2). The COVID-19 pandemic exposed significant vulnerabilities in the EU’s pharmaceutical supply chain.

Access to medicines varies considerably from Member State to Member State. According to a recent survey conducted by the EU4Health programme-funded Joint Action of Member States on shortages (CHESSMEN), over 50% of reported shortages in 2022 and 2023 were caused by manufacturing issues, in particular, shortages in APIs (see Table I [3–4]).

The European Medicines Agency (EMA) regularly updates its list of critical medicines to ensure it can take proactive measures to avoid medicine shortages (5). It has set up the European Shortages Monitoring Platform (ESMP) to gather information about medicine availability, supply, and demand to prevent, detect, and manage human medicine shortages in the EU and European Economic Area (EEA). As per Regulation (EU) 2022/123, a ‘shortage’ is defined as “a situation in which the supply of a medicinal product that is authorized and placed on the market in a Member State […] does not meet the demand for that medicinal product […] at a national level, whatever the cause” (6). However, there is currently no harmonized definition on the EU level for a potential shortage.

Recommendations from the Critical Medicines Alliance

In January 2024, the EC launched the Critical Medicines Alliance (CMA) to “identify challenges resulting from vulnerabilities and the most appropriate actions and instruments to address the vulnerabilities in the supply chains of critical medicines, with the primary public health goal of reducing the risk of shortages of those critical medicines” (7). In February 2025, the Alliance published its Strategic Report laying out a set of recommendations (8).

The Critical Medicines Act aims to address the issues raised by:

strengthening Europe’s manufacturing capacity

The EC’s proposal aims to overhaul procurement rules allowing EU Member States to prioritize the security of supply based not only on price but on additional criteria including stockholding obligations, the number of diversified suppliers, monitoring of supply chains, transparency, and performance clauses. Where appropriate, preference will be given to suppliers that manufacture a significant proportion of critical products in Europe and EU Member States or the EC may undertake joint procurement of critical medicines (2).

EU countries can provide financial support for ‘strategic projects’ to improve and expand the EU’s manufacturing capabilities of critical medicines, APIs, or starting materials. These funds are not available for non-critical medicines. EU funding will be accessible through the Strategic Technologies for Europe Platform (9).

A Critical Medicines Coordination Group, composed of representatives from each Member State, will be established to provide information on manufacturing capabilities, identify strategic projects for state support, and pinpoint areas of vulnerability in the supply chains (2).

Given the turbulent geopolitical landscape, it is paramount that the EU has access to a stable and reliable supply chain for essential medicines. The Critical Medicine Act complements the revised pharmaceutical legislation and will help the EU to improve its preparedness and resilience, strengthen its overall security, and increase the EU’s competitiveness within the global pharmaceutical arena (10). 

EC. Proposal for a Critical Medicines Act.

O’Neill, R. EU Plans to Boost Medicines Manufacturing in Drug Shortages Bill. 

 Identifying the Root Causes of Observed Shortages of Medicines

EMA. European Shortages Monitoring Platform (ESMP) Frequently Asked Questions (FAQs). 

CMA. Strategic Report of the Critical Medicines Alliance. 

EU. Strategic Technologies for Europe Platform (STEP). 

EC. Reform of the EU Pharmaceutical Legislation. 

Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.

When referring to this article, please cite it as Barton, C. Critical Medicines Act Plans to Improve Supply Chain. 

The Act is the European Union’s plan to avert drug shortages.

Critical Medicines Act Plans to Improve Supply Chain  

On 30 Jan. 2025, the European Commission (EC) launched a new Biotech and Biomanufacturing Hub to help European Union (EU) businesses, particularly small and medium enterprises (SMEs), to access support, expand, and grow (1).

The Hub offers access to EU funding for research and development (R&D), business development tools to market products on a global scale, regulatory guidance on product approval, and compliance and support for intellectual property rights to protect innovative products (1).

The Hub is accessible on the EC’s Your Europe portal to EU nationals, nationals of European Arenas Association (EAA) countries, family members of EU/EEA nationals, non-EU nationals that enjoy EU rights, and businesses with headquarters in a EU country (2). A task force of advisors will guide the continuous development of the portal (3).

In June 2023, the EC proposed a regulation to establish a new platform for Strategic Technologies for Europe Platform (STEP) (4). STEP aims to support the development and manufacturing of critical technologies and to address any shortage of labour and skills. Several proposals were outlined in STEP to boost biotechnology and biomanufacturing in the EU, these are summarized in 

Figure 1. Proposals outlined in the European Commission’s Strategy to boost biotechnology and biomanufacturing in the EU. Figure courtesy of the author

On 1 March 2024, the STEP Regulation (Regulation (EU) 2024/795) came into force (6). The STEP platform has access to €160 billion in funds to invest in strategic projects that develop or manufacture critical technologies namely:

biotechnologies—molecular biotechnology, pharmaceuticals, crop biotechnology.

clean and resource-efficient technologies—capture and storage technologies, and heat pumps.

digital technologies and deep technology innovation—artificial intelligence (AI), advanced connectivity, and quantum technologies (4).

STEP stakeholders include governments, regulatory bodies, industry leaders, research institutions, and the public. The STEP Task Force coordinates and cooperates with stakeholders to address funding challenges and identify new opportunities.

The EU aims to bolster its industrial competitiveness, enhance its strategic autonomy and resilience, and boost its economic security through investment in biotech and biomanufacturing, and the Hub is a key element of the EC’s strategy (7).

STEP has invested in 11 EU programmes including:

Digital Europe Programme (DEP): Provides funding for projects including advanced digital skills AI, cybersecurity, supercomputing, and ensuring the wide use of digital technologies across the economy and society (8).

European Defence Fund (EDF): This supports collaborative research and development (R&D) of defence capabilities with the EU budget (9).

EU4Health: Established in response to COVID-19’s impact on medical and healthcare staff, patients, and health systems in Europe. It aims to improve and foster health in the EU (10).

Horizon Europe (HE): Aims to tackle climate change and helps to achieve the United Nations’ (UN’s) Sustainable Development Goals and boosts the EU’s competitiveness and growth (11).

Innovative Fund (IF): One of the world’s largest funding programmes for the demonstration of innovative low-carbon technologies (12).

Additional funding has been provided by STEP to the European Regional Development Fund (ERDF), Cohesion Fund, European Social Fund+ (ESF+), InvestEU, Just Transition Fund (JTF), and Recovery and Resilience Facility (13).

The EC continues to strengthen the competitiveness and resilience of the European economy through investment in transformational technologies. The investment in the Biotech and Biomanufacturing Hub will not only support innovative European biotechs but also sends a clear message to the rest of the world that Europe means business (14).

EC. New Biotech Hub to Support Companies. ec.europa.eu. 20 Jan 2025.

Stur, B. New Biotech and Biomanufacturing Hub Will Support Innovative European Companies. European Interest. 2 Feb 2025

EC. Your Europe–Advice. ec.europa.eu (accessed 14 Feb. 2025).

EP. Strategic Technologies for Europe Platform (STEP). Think Tank. 15 Feb 2024.

Eteris, E. Biotechnology and Biomanufacturing in the EU: Perspective Strategy - Analytics, EU Law & Governance. Analytics, EU Law & Governance, Integrin Dk. EG in Europe. 15 May 2024

EC. Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 Establishing the Strategic Technologies for Europe Platform (STEP) and Amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241. ec.europa.eu. 29 Feb. 2024.

EC. Building the Future with Nature: Boosting Biotechnology and Biomanufacturing in the EU. EC.europa.eu. 20 Mar 2024.

EC. Digital Europe Programme. ec.europa.eu (accessed 14 Feb. 2025).

EC. European Defence Fund. ec.europa.eu (accessed 14 Feb. 2025).

EC. EU4Health. ec.europa.eu (accessed 14 Feb. 2025).

EC. Horizon Europe is the EU’s Funding Programme for Research and Innovation. ec.europa.eu (accessed 14 Feb. 2025).

EC. Innovation Fund. ec.europa.eu (accessed 14 Feb. 2025).

EC. STEP Strategic Technologies For Europe Platform. June 2024.

Yadav, R. European Commission Launches Biotech and Biomanufacturing Hub. The Bioeconomy. 31 Jan. 2025.

When referring to this article, please cite it as Barton, C. Launching the New Biotech and Biomanufacturing Hub. 

The Biotech and Biomanufacturing Hub will help European companies access funding, navigate regulations, and speed up market access.

Launching the New Biotech and Biomanufacturing Hub  

Two dosing pens of a fictitious semaglutide drug (GLP-1) on a scale facing a dumbbell. Concept for alternative ways to loose weight. | Image Credit: © Andreas Prott - Stock.adobe.com

Obesity is a major public health threat and is associated with an increased risk of obesity-related complications and mortality. It has proved a challenging target for pharmaceutical intervention, and early strategies using amphetamine-based appetite suppressants resulted in significant side effects and high-profile lawsuits against manufacturers (1).

Better understanding has fuelled product development

A better understanding of the gut-brain axis has led to the development of oral glucagon-like peptide-1 (GLP-1) receptor agonists (RA) and glucose-dependent insulinotropic polypeptide (GIP) RAs for the treatment of type 2 diabetes (T2D) and weight management (

). These include Novo Nordisk’s oral Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide) and Eli Lillys’ once-weekly GIP/GLP-1 dual agonist Mounjaro (tirzepatide), which was approved by the European Medicines Agency (EMA) in 2202 to manage weight (2,3).

Regulatory-approved anti-obesity medicines.

Next-generation anti-obesity medicines are emerging

GLP-1 agonists and GIPs are not without their side effects, so companies are researching new drug targets, combinations, and formulations to overcome these shortfalls and provide safer, more robust, and sustainable body weight loss (3-6). According to IQVIA, 116 new anti-obesity medicines (AOMs) are in clinical development (

). Several of the agents modulate novel targets such as amylin, cannabinoid receptor type 1 (CB-1), diacylglycerol O-acyltransferase 1 (DGAT1), monoacylglyceroltransferase (MGAT2), and solute carrier 6 (SLC6) transporters.

 Anti-obesity agents in clinical development. 

European biopharma companies are looking beyond GLP-1s.