CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More

Behind the Headlines, Episode 20

ICH Q12 and Post-Approval Changes

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

: Behind the Headlines Episode 14–Investment Trends, Policy Realignments, and Vaccines

Behind the Headlines is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 14, panelists Christian Cobaugh, PhD, CSO and founder of Vernal Biosciences; Eswar Iyer, PhD, co-founder and CSO, Aikium Inc., and Vincenzo Antignani, PhD, Technical training lead, Asahi Kasei Bioprocess America, Inc., adjunct facility Northeastern University & Governing Committee (GC) Member, NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals, discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old. 

Performance advances in both China and India have led to renewed investments from other countries into both infrastructure and licensing agreements. Novo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion (1). In addition, AstraZeneca is committing up to $11 billion to Chinese Collaborations including a Beijing R&D Hub (2).

Changing skills requirements for future workforce in a time of turmoil was a major consideration for the panel, appearing and reappearing throughout the conversation. It included the re-folding of recently fired National Institutes of Health workers, as Robert F. Kennedy, Jr. pursues his plans to slash the Department of Health and Human Services’ workforce by 25%, implement massive reorganization, and consolidate authorities, creating a new agency for a ‘Healthy America’ (3).

Conversation also turned to attitudes toward messenger RNA, as the United States outlines plans to end vaccine funds for poor countries, in parallel to several other efforts to frame vaccines as just-one-choice-among-many-options, to discuss with one’s healthcare provider (4).

Lastly, 23andMe’s future in bankruptcy protection after having held, at its highest, a market valuation of $6 billion dollars, was bruited about. The panel also examined the company’s chances of legally selling customer genomic data as a lift raft, and also, what the demise of such a pioneering company means in the overall commercial landscape at this time.

Click the video above to watch the discussion.

1. Sunny, M. Novo Bets on 'Triple G' Obesity Drug in up to $2 billion Deal with Chinese Biotech. 

https://finance.yahoo.com/news/novo-licenses-chinese-biotechs-obesity-102141800.html

2. Philippidis, A. AstraZeneza Commits Up to $11B+ to Chinese Collaborations, Beijing R&D Hub, 

Genetic Engineering and Biotechnology News

https://www.genengnews.com/topics/drug-discovery/astrazeneza-commits-up-to-11b-to-chinese-collaborations-beijing-rd-hub

3 Owermohle, S.; Lawrence, L.; and Bannow, T. RFK Jr. Plans to Slash HHS Workforce by 25% in Massive Reorganization. 

https://www.statnews.com/2025/03/27/rfk-jr-10000-job-cuts-hhs-restructuring-health-agency-impacts-cdc-fdaG-nih-cms

4Kirchgaessner, S.; Glenza, J. Trump Administration at ‘War’ with mRNA Technology: Scientists Alarmed Vaccine Skeptics Could Kill Research. 

https://www.theguardian.com/us-news/2025/mar/27/trump-vaccine-skeptics-research-funding

5. Satija, B.; Shah, A.; Misra, S. DNA Testing Firm 23andMe Files for Bankruptcy as Demand Dries Up. 

https://www.reuters.com/business/healthcare-pharmaceuticals/dna-testing-firm-23andme-files-chapter-11-bankruptcy-sell-itself-2025-03-24/

Videos

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old. 

Behind the Headlines Episode 14–Investment Trends, Policy Realignments, and Vaccines

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

INTERPHEX 2025: AI and Automation in Pharma

Automation is being utilized in the areas of quality, throughput, and operator autonomy within the pharmaceutical industry, according to Peter Sarvey, head of Sales for Automation NTH, and the cost of using automation has decreased in the past two years. Meanwhile, the accuracy of these tools is increasing.

The use of artificial intelligence (AI), which has been used in the “vision side” of automation according to Sarvey, is also increasingly starting to be used in the inspection side of manufacturing.

“When we have a lot of part variation, we're not just programming pick and place, or motion based on preset points. So, we move to an area, and then we use the AI vision to tell us, where is that exact part or how much has that part changed? So, it actually allows the automation to move more seamlessly,” Sarvey says. “And then the other side of that is on the inspection side of things. There are a lot of inspections that previously were done manually, because it's not a simple pattern match for if this medical device or this pharmaceutical component is a reject. Now we can teach the AI what a good part looks like, what a bad part looks like, and then over time, shift that area too, all in the nature of increasing throughput and decreasing yield loss.”

® Group spoke with Peter Sarvey at INTERPHEX 2025, which is being held in New York City from April 1–3. Automation NTH can be found at Stand 3061.

Peter Sarvey is Head of Sales for Automation NTH, a specialist in semi-automated and fully automated solutions for a broad array of manufacturing applications, including pharmaceuticals and medical device production. With a focus on next-gen robotics and controls, the company’s services include custom automation, equipment optimization and automation consulting. 

Pharmaceutical Technology® Group spoke with Peter Sarvey, head of Sales for Automation NTH, at INTERPHEX 2025 about the growing use of automation and artificial intelligence in the pharmaceutical industry.

INTERPHEX 2025: Automation for Protein Manufacturing

Biomanufacturing involves complex operations and thousands of skilled workers, says Kerry Love, co-founder and CEO of Sunflower Therapeutics, a biotech company specializing in continuous and fully integrated equipment for the production of proteins. Automation can be a way to build quality and reduce human errors, while also allowing workers who might not be as skilled to participate in high-value manufacturing.

“When you use automation in general, you kind of make something that's usually highly complex, with a lot of handoffs and transitions, much less complicated, particularly in continuous bioprocessing," Love says in the interview. "That's actually a great place for automation, because already you're simplifying unit operations and making interfaces between unit operations that oftentimes haven't been there in the past. That's a great way to then layer automation on top of that and ultimately get to walk away solutions like those that we build at Sunflower.”

® Group spoke with Love at INTERPHEX 2025, being held April 1–3 in New York City. Sunflower Therapeutics can be found at Stand 1273.

Kerry Love, co-founder and CEO of Sunflower Therapeutics

Kerry Love, PhD, is the co-founder and CEO of Sunflower Therapeutics, a women-owned and led biotechnology company delivering next-generation protein manufacturing solutions that anyone can use to create innovative new medicines, vaccines, foods, and other bio-produced materials. Love is an organic chemist by training, performing her doctoral studies at MIT, and a biotech entrepreneur at heart, having founded two companies and contributed to the starting of many more over the past 20 years.Love has authored more than 40 scientific papers and patents.

The Pharmaceutical Technology® Group spoke with Kerry Love, co-founder and CEO of Sunflower Therapeutics at INTERPHEX 2025, to find out how automation enhances the manufacture of proteins.

TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com

FDA announced on April 1, 2025 that Martin A. Makary, MD, has been sworn in as the agency’s new commission after a bipartisan confirmation by the US Senate. Makary, a graduate of Bucknell University, Thomas Jefferson University, and the Harvard School of Public Health, completed his residency at Georgetown University and surgical oncology fellowship at Johns Hopkins.

He founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and led cross-disciplinary research on cancer, obesity, Alzheimer’s, adverse event monitoring, and antimicrobial resistance. He is a member of the National Academy of Medicine and co-developer of the Surgery Checklist.

“I am honored and humbled to assume this role at the FDA under the leadership of President Trump and Secretary Kennedy,” said FDA Commissioner Martin A. Makary, in the press release (1). “I look forward to working with this Administration and the FDA workforce to advance our shared goals in meeting the agency’s public health mission. As Commissioner, I hope to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense so that we can Make America Healthy Again.”

“I am pleased to welcome Dr. Makary to the U.S. Department of Health and Human Services and the Food and Drug Administration,” said HHS Secretary Robert F. Kennedy, Jr., in the release. “He is a national leader in medicine with impeccable credentials. His extensive research, clinical experience, and national leadership make him uniquely qualified to lead the FDA as we work together to Make America Healthy Again.”

Back in January 2025, FDA leaders, Commissioner Robert Califf and the Director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, resigned their posts (2–4). And in March 2025, Peter Marks, director of the Center for Biologics Evaluation and Research resigned (5).

Califf warned of misinformation on his way out of office. "We are currently losing the battle due to the intersection of social media and cultural changes, which threatens the foundation of public health," Califf said. “A lot of people died who would not have died if they had gotten a free vaccine and not been misled [about the safety of vaccines]” (3).

The concern over misinformation was also on the mind of Marks, who stated the following in his resignation letter (6):

“Over the past 13 years, I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said. “As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

1. FDA. Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner. Press Release. April 1, 2025.
2. Herper, M. Leaving FDA, Califf is Unapologetic—and Warns of Staff Departures. 

. Jan. 8, 2025.
3. Eglovitch, J. S. Goodbye Message: Califf Says FDA Needs Help in Battling Misinformation, Has Deep Talent Pool to Mitigate Departures. 

. Jan. 17, 2025.
4. Haigney, S. Cavazzoni Retires as CDER Director. 

https://www.pharmtech.com/view/cavazzoni-retires-as-cder-director


5. Haigney, S. FDA CBER Director Peter Marks Resigns. 

. March 31, 2025.
6. Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by 

Articles

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Martin A. Makary Becomes New FDA Commissioner

Feliza Mirasol is the science editor for 

INTERPHEX 2025 video interview with Iwata Label USA discussing practical security benefits of functional labels for parenteral drugs.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes

Sitting down with the PharmTech Group at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, a division of Japan-based IL Group, highlights the need for improved protection of pharmaceutical vials and syringes, particularly through functional labels. Previously, vials were not sufficiently protected due to cost considerations, but after conducting recent studies, the company began to understand the financial and human costs of breakage. Instead of overhauling packaging, however, Wainwright asserts that functional labels can reinforce existing vial infrastructure by preventing breakage, cracks, and leaks.

“We traditionally have not protected the vials as stringently as we should and could, just simply for cost reasons. It's just now that we've done more studies on the costs associated with broken vials, or even the human cost of negative effects to healthcare workers, [that] the need for heightened protection on vials has increased,” Wainwright says in the interview. “And then with functional labels, what they can do is, instead of reimagining the whole packaging system, you can use existing packaging infrastructure, [such as] the traditional vials, but then add on a specialty label that helps protect the vial from breakage, cracks, or seepage of the internal contents.”

He goes on to explain that, for syringes, the primary concern is material-induced drug migration, which can alter the chemical composition of highly potent medications. Preventing migration is critical to maintaining drug integrity. Another key function of these labels is shielding vial and syringe contents from light exposure, which can degrade pharmaceutical compounds. Functional labels, therefore, serve a dual purpose: physical protection and preservation of drug stability.

Wainwright also expresses enthusiasm for engaging with industry leaders at INTERPHEX 2025 to encourage broader adoption of these specialized labeling solutions within the pharmaceutical sector.

Attendees can visit Iwata Label USA at Booth #1362 at INTERPHEX, which is being held on April 1–3 in New York City.

William Wainwright, Business Development Manager, Iwata Label USA, a division of IL Group

William Wainwright is business development manager for Iwata Label USA, a division of IL Group, and a provider of precision labeling solutions for global pharmaceutical and healthcare companies. The company’s portfolio includes good manufacturing practice-compliant roll-on and shrink-tack labels featuring value-added benefits, such as tamper evidence, protection against breakage, and light-shielding properties, as well as specialty constructions whose functions range from reliable adhesion in cryogenic applications to detachable elements for ease of medical recordkeeping.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

AES Clean Technology (AES), a provider of modular cleanroom solutions, announced on April 1, 2025 that it has officially launched Omni ASCENT, a next-generation off-site manufactured (OSM) vertical utility solution that is designed to optimize the flexibility and efficiency of cleanrooms, at INTERPHEX 2025. The company said in a press release that the launch of this OSM solution is a significant advancement toward cleanroom utility integration (1). INTERPHEX is being held on April 1–3 in New York City.

Omni ASCENT is built on the foundation of AES’s Omni utility raceway, which is a system that integrates critical cleanroom utilities into a modular, adaptable framework. Omni ASCENT enables strategic placement of utilities anywhere on the cleanroom floor. In comparison, traditional systems limit layout options and pose challenges to accessibility, according to AES in the press release. Omni ASCENT enables greater flexibility, efficiency, and safety, and allows pharmaceutical and biotech facilities to optimize space and workflow without having to compromise compliance, according to the company.

“Omni ASCENT is a direct response to the evolving needs of modern cleanroom environments,” said Shawn Reniker, senior vice-president of Operations, AES Clean Technology, in the release (1). “By eliminating the need for wall or ceiling-mounted utilities, we are giving manufacturers the freedom to configure layouts more efficiently, enhance accessibility for maintenance and operations, and accelerate deployment—all while maintaining the highest industry standards.”

Omni ASCENT is designed for rapid deployment; it arrives fully assembled and ready for installation, which can be done in under half a day. This shortened deployment significantly reduces downtime. Meanwhile, its strategic utility placement enhances ergonomics while creating a safer workspace by eliminating unnecessary ladder use and tripping hazards. In addition, the new system can be easily integrated with existing Omni raceway solutions. This compatibility facilitates a streamlined transition for both new cleanroom builds and facility retrofits, according to the press release.

“Last year, the CleanLock Module reinforced the demand for smarter, more flexible cleanroom solutions. Omni ASCENT builds on that momentum, providing even greater adaptability in utility integration and ensuring that facilities can scale efficiently without redesigning their infrastructure,” said Chris Miller, chief executive officer, AES Clean Technology, in the release.

 the CleanLock Module, which is an airlock solution for cleanrooms that has been engineered to minimize the risk of contamination. The module minimizes contamination risk by integrating AES’ proprietary cleanroom finishes, patented lighting, predictable airflow patterns, and advanced door controls. These features offer the advantage of being integrated into any facility without delay. The module allows for secure transition of people and materials entering and exiting cleanrooms.

"We are thrilled to introduce the CleanLock Module airlock to the market," said Grant Merrill, AES chief commercial officer, in a press release at the time of the CleanLock Module launch in 2024 (2). "This product addresses the critical need for maintaining ultra-clean environments in industries such as pharmaceuticals, biotechnology, and medical device manufacturing. With its state-of-the-art technology and precision engineering, the CleanLock Module will set a new standard for contamination control and efficiency in design and construction execution."

Attendees can visit AES at Booth #2509 at INTERPHEX 2025.

1. AES Clean Technology. AES Cleanroom Technology Introduces Omni ASCENT: A Breakthrough in Cleanroom Utility Integration at INTERPHEX 2025. 

. April 1, 2025.
2. AES Clean Technology. AES Clean Technology Sets New Standards for Cleanliness and Efficiency in Cleanrooms with the Launch of Its CleanLock Module. Press Release. April 16, 2024.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

AES Clean Technology Introduces OSM Cleanroom Utility Solution at INTERPHEX 2025

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

Culture Biosciences, headquartered in South San Francisco, Calif., is announcing the launch of Stratyx 250, which the company said in a press release is the first mobile, cloud-integrated bioreactor that is designed to provide biotech companies with simultaneous flexibility, automation, and remote process control (1).

The launch coincides with the start of the 2025 INTERPHEX conference in New York City, which runs from April 1–3, 2025.

Culture Biosciences defines cloud-based bioprocessing as the integration of physical bioreactors with remote data monitoring, automation, and artificial intelligence (AI)-driven optimization (1). The company has designed Stratyx 250 to allow researchers to leverage its Culture Console software for remote tracking and adjusting of parameters in real time.

The end results, according to Culture Biosciences in the press release, include reduction of errors, improved reproducibility, and greater precision and efficiency (1). This is especially important, the company said, considering that biotech companies are generating massive amounts of process data given the rise in high-throughput experimental methods, but may lack the ability to efficiently derive actionable insights from that data.

“The biotech and biopharmaceutical market segments are experiencing a major shift toward cloud-powered, modular bioprocessing, and these companies need hardware and software that can keep up,” said Chris Williams, CEO of Culture Biosciences, in the release (1). “With a five-month ROI [return on investment] timeline and a plug-and-play scalable architecture, our platform offers a cost-effective, flexible alternative to traditional bioreactors—helping companies accelerate development and reduce costs without compromising on quality.”

According to the press release, Stratyx 250 affords users a 16% lower total cost per run versus traditional benchtop bioreactors, development timelines that are faster by up to 25%, and a 30% improvement in scale-up success (1).

In discussing its offering of an “early adopter” program for select customers, Culture Biosciences provided the perspective of Jondavid De Jong, PhD, vice president of Scientific Operations for Virica Biotech.

“Stratyx 250 is already reshaping how we approach process development,” De Jong said (1). “The ability to remotely monitor and adjust experiments in real time is streamlining our workflows and improving reproducibility across runs. The combination of cloud integration, automation, and mobility makes it a game-changer for modern bioprocessing.”

®, Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products, said that 

automation has been playing a larger role

 in advancing equipment that supports bioprocessing, highlighting digital twin technology, integrated control systems, automated sampling and analysis, and smart bioreactors as some of the developments being witnessed in the biomanufacturing space—including at the commercial level (2).

“From what our team has seen, most commercial biomanufacturing processes are partially automated, with automation implemented in upstream (e.g., bioreactors, feeding systems) and downstream (e.g., chromatography, filtration) steps,” Christopher said, qualifying that manual intervention is needed for setup, troubleshooting, and quality control, but that many facilities now use automated systems for data collection, process monitoring, and quality assurance (2).

Culture Biosciences said Stratyx 250 is currently being demonstrated at its South San Francisco facility (1). The company can also be found at Booth #3417 at INTERPHEX, being held at the Javits Center in New York City.

1. Culture Biosciences. Culture Biosciences Unveils Stratyx 250, the First Cloud-Integrated, Mobile Bioreactor for Cell Culture Process Development. Press Release. April 1, 2025.
2. Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.

Culture Biosciences Opens INTERPHEX 2025 with Launch of Cloud-Integrated Mobile Bioreactor

On April 1, 2025, BioPure, a provider of single-use solutions and part of Watson-Marlow Fluid Technology Solutions (WMFTS), announced that it has refined the manufacturing of its single-use sanitary connector, BioClamp, to offer sustainability benefits to users. The company will showcase the connector at INTERPHEX 2025, occurring April 1–3 in New York City.

BioPure, which introduced the first single-use sanitary bioclamp for bioprocessing in 1998, according to a company press release (1), has optimized BioClamp in terms of its design and its manufacturing process. Under the new manufacturing process and new design, the connector is 13% lighter in weight compared to the previous BioClamp model. The adoption of advanced automated assembly has also resulted in 26% less carbon dioxide emissions during manufacturing across the full lifecycle of the product (1). BioClamp securely attaches sanitary fittings and plays a crucial role in single-use critical fluid transfer lines.

“From enhanced production to shipment, use in a bioprocess and end-of-life disposal, BioClamp is designed for sustainability while maintaining the highest quality standards,” said Mark Lovallo, product manager for WMFTS, in the press release (1). “BioClamp is efficiently manufactured, pre-assembled, and packaged at our global network of state-of-the-art Class 7 cleanrooms, which gives users of our sanitary bioclamp confidence in quality and sustainability as they scale up their production. These facilities are ISO14001 certified and powered by renewable energy.”

An additional upgrade to the bioclamp is an advanced ergonomic hinge that makes it easier to close and simplifies the set-up of an assembly process, allowing for quick changeovers. Other features and benefits include:

reduced distortion on polymeric fittings when subjected to heat

suitability for sterilization using autoclave and gamma irradiation

suitability for either single-use or multiple-use applications

reliable availability of global manufacturing and supply network.

WMFTS has the goal of reaching net-zero for its scope 1 and 2 emissions (i.e., emissions that are in its direct control) and reducing scope 3 emissions (i.e., those emissions that the company is indirectly responsible for, up and down its value chain) by 2030. Optimizing the manufacturing process for the BioClamp connector is a significant step toward that goal.

Speaking with Nicole Hunter, head of Global WMArchitect at WMFTS last year at 

 the PharmTech Group discussed the importance of optimizing fluid-handling workflows in the bioprocessing space and the efficiencies that single-use technologies (SUTs) can offer for biomanufacturing (2).

“One of the main reasons to have really good workflows is to reduce the risk in your process. You want to … safeguard your therapeutic during the process and expedite getting that drug product to the patient,” Hunter said in the interview (2).

Hunter noted that the big advantages SUTs bring are flexibility and adaptability to bioprocessing. “What [SUTs] have been able to do—in moving away from stainless-steel systems—is to allow for quick changeover between drug products. One facility can make multiple drug products really easily; the manufacturing systems can be quickly assembled for the different drug products and changed out as, and when, needed. [SUT] also reduces risk of cross contamination because you're literally using that assembly for that drug product and then changing to another one,” she explained in the interview (2).

Attendees can visit WMFTS at Booth #2753 at INTERPHEX 2025.

1. Watson-Marlow Fluid Technology Solutions. 

BioPure Advances Manufacturing of BioClamp to Bring Significant Sustainability Benefits to Its Users

. Press Release. April 1, 2025.
2. Mirasol, F. 

Single-Use Technologies Reinforce Fluid-Handling Workflows (INTERPHEX 2024)

With advanced manufacturing, BioPure’s BioClamp connector is manufactured to be 13% lighter than the previous model, resulting in a 26% reduction in carbon dioxide emissions across the full lifecycle of the product.

WMFTS’ BioPure to Showcase Single-Use Bioclamp with Refined Manufacturing at INTERPHEX 2025

Mike Hennessy Jr. is the President and CEO of 

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

The bio/pharma industry is not unfamiliar with “patent cliffs”; however, the current one being faced is notably steep and, in combination with other factors, is set to negatively impact revenues significantly in the near future. A similarly steep patent cliff was experienced by the bio/pharma industry during the 2000s, but at that time industry had the benefit of pricing tailwinds in the United States, helping industry to overcome the related revenue slump (1).

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players and potentially leading the industry to lose up to $400 billion (2). For example, Merck’s humanized antibody therapy, pembrolizumab (Keytruda), is scheduled to lose its patent in 2028; Regeneron/Bayer’s anti-vascular endothelial growth factor therapy, aflibercept (Eylea), is expected to lose its patent either in 2025 or 2026; and Eli Lilly’s glucagon-like peptide-1 receptor agonist, dulaglutide (Trulicity), is set to lose patent protection in 2027 (3).

Furthermore, while this hefty patent cliff is ongoing, industry is also facing a raft of other issues that are straining profit margins. Issues such as newer and more complex therapeutic modalities are trending, which are more expensive for companies to develop and are targeted at smaller patient populations; various geopolitical tensions are causing supply chain concerns; new legislation is shortening the exclusivity period for drugs; and investment being heavily placed on trending disease areas and specific technologies (1).

However, while the patent cliff will need companies to strategically pivot to negate revenue losses, potential opportunities may open up for other companies seeking to develop a generic or biosimilar form of the blockbuster drugs. According to research, many of the biologic therapies that are set to lose their patent exclusivity in the coming years have no biosimilars in development (4). Such a gap in the market could be a lucrative opportunity indeed.

Möller, C.; Kristic, S.; Walker, G.-C.; Aguilar, J.; Chandran, P. Biopharma’s Patent Cliff Puts Costs Front and Center. BCG, Article, Feb. 18, 2025.

DeAngelis, A.; Feuerstein, A. With a Major Patent Cliff Coming, Will JPM Play Host to Some Serious Deal-Making? STAT, Jan. 8, 2025.

Burke, H. Top 10 Drugs with Patents Due to Expire in the Next Five Years. Proclinical, Feb. 16, 2024.

Jeremias, S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. AJMC, Feb. 5, 2025.

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Facing the Latest Patent Cliff. 

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

Facing the Latest Patent Cliff

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Industry Outlook 2025: Political Impacts on Supply Chains

Diversifying where a company sources ingredients and products is an important part of keeping the supply chain robust, says Will Gordon, senior vice president of Product Management, ArisGlobal, and companies must be able to adapt to geopolitical instability to continue to secure the supply chain.

“If something happens in X country, are you able to quickly shift capacity to develop whatever it is to another country or another area? And if we look at what's happening in the United States, there's this BIOSECURE Act, and that's kind of similar, right? So, the US government could, at any point say, ‘Okay, this company is associated to this government, and they're a non-friendly government, and so we're no longer going to allow you to source products from that if you have any federal funds.’ Well, most pharmaceutical companies receive federal funds because government is a large purchaser of pharmaceutical product, right? So, you have to be able to say, okay, how can we shift capacity? How can we shift our supply chains? And I think the pharmaceutical companies of the world have done a really good job at creating that robustness across the supply chain, from sourcing all the way to delivery, and they just have to continue to be nimble and shift as political changes come up,” says Gordon.

Click the video above to watch the full interview.

Will Gordon, senior vice president of Product Management, ArisGlobal.

Will Gordon is senior vice president of Product Management, ArisGlobal.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about how the geopolitical instabilities might impact the bio/pharmaceutical industry. 

Featured Content

Behind the Headlines, Episode 20

ICH Q12 and Post-Approval Changes

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know