Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

After hosting the first international scientific workshop on nanomedicines earlier this month, the European Medicines Agency (EMA) has concluded that further research is needed to provide an adequate scientific basis for evaluating the quality, safety and efficacy of such medicines. However, the EMA and workshop attendees also admitted that nanomedicines have huge potential in the medical world, and could lead to refined drug delivery, advanced combined diagnostics/therapeutic functions, and matrices and support structures for regenerative medicines.

, 200 participants from 27 countries attended the workshop to discuss the benefits and challenges of applying nanotechnologies to medicines. Attendees shared experience, reviewed existing and emerging nanomedicines, and discussed a number of scientific aspects to identify knowledge gaps and to prepare for the evaluation of future nanomedicines. 

“Preparedness is essential for enabling timely introduction of safe and efficacious nanomedicines of a high quality, as nanotechnologies bring not only opportunities to improve current treatments, but also the potential to change the way we approach healthcare and diseases,” Patrick Le Courtois, Head of Unit Human Medicines and Development at the EMA, said in the press statement.

A number of nanomedicines have already been authorized by the EMA, including Caelyx, Mepact, Abraxane and Rapamune. The products were assessed under the existing regulatory framework. However, the EMA also added in its press statement that: “Emerging therapies give rise to questions on the appropriateness of current regulatory frameworks, the relevance and adequacy of existing requirements and guidelines, and on the availability of adequate expertise to regulators.”

In particular, scientific challenges arise from limitations of current testing methods, and the reliability of novel ones, because of the nanosize and the unique behavior of nano-systems in biological structures. 

The EMA has said that it will extend existing platforms for further dialogue on emerging science, needs of patients and expectations from all stakeholders to keep up to date with scientific progress and to provide a regulatory environment that is “adequate for innovation based on science centered around patients’ needs”.

Articles

After hosting the first international scientific workshop on nanomedicines earlier this month, the European Medicines Agency (EMA) has concluded that further research is needed to provide an adequate scientific basis for evaluating the quality, safety and efficacy of such medicines.

Nanomedicines in EMA spotlight

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasised the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonised, global approach to biosimilars in general, at the agency’s 8th International Symposium on Biosimilar Medicines.

“As regulations fall into place worldwide, there is a need to reach a global agreement on criteria and guidelines for biosimilar medicines in the interest of patients and the better availability of high quality medicines,” said Perry in an 

Progress towards biosimilars regulation has been made in a number of countries outside the EU, including Australia, Canada, Japan, Turkey and the US, and the EGA believes the time is fast approaching to undertake a “benchmarking” exercise. “A consistent, scientific global approach is essential to move towards true global development of biosimilars medicines,” said the EGA statement.  

Steps towards a global, harmonised regulatory approach may already be in sight, with the World Health Organization (WHO) due to finalize its guidelines on the evaluation of biosimilars in 2011. According to the EGA, the guidelines will be founded on the same basic scientific principles as in the EU. 

In particular, Perry also highlighted the importance of mAbs at the symposium and the need for “workable” guidance in this area. Indeed, according to Peter Gaskin, a Principal Consultant at Aptuit Consulting, a number of companies are already targeting mAbs for biosimilar development. In an 

, Gaskin explained that EU guidelines for biosimilar mAbs would be a significant development, particularly as mAbs represent some of the biggest selling products.

“If healthcare systems are to continue to function long-term, we must address the importance of biosimilar mAbs next,” said Perry. “Science for mAbs is already here today and our industry is expecting a workable guideline.”

For more information about biosimilars, take a look at Pharmaceutical Technology Europe’s special feature: 

Bioimilars: Too steep a mountain to climb?

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasised the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonised, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

Call for "workable" guideline for biosimilar mAbs

After hosting the first international scientific workshop on nanomedicines earlier this month, the European Medicines Agency (EMA) has concluded that further research is needed to provide an adequate scientific basis for evaluating the quality, safety, and efficacy of such medicines.  EMA and workshop attendees also said, however, that nanomedicines have huge potential in the medical world, and could lead to refined drug delivery, advanced combined diagnostics/therapeutic functions, and matrices and support structures for regenerative medicines.

“Preparedness is essential for enabling timely introduction of safe and efficacious nanomedicines of a high quality, as nanotechnologies bring not only opportunities to improve current treatments, but also the potential to change the way we approach healthcare and diseases,” Patrick Le Courtois, head of unit human medicines and development at  EMA, said in the press statement.

A number of nanomedicines have already been authorized by EMA, including Caelyx (pegylated liposomal doxorubicin hydrochloride, Merck, Whitehouse Station, NJ), Mepact (mifamurtide, Takeda, Osaka, Japan), Abraxane (paclitaxel injection, Abraxis BioScience, Los Angeles) and Rapamune (sirolimus, Pfizer, New York). The products were assessed under the existing regulatory framework. EMA added, however, in its press statement that, “Emerging therapies give rise to questions on the appropriateness of current regulatory frameworks, the relevance and adequacy of existing requirements and guidelines, and on the availability of adequate expertise to regulators.”

In particular, scientific challenges arise from limitations of current testing methods, and the reliability of novel ones, because of the nanosize and the unique behavior of nanosystems in biological structures. 

EMA  said that it will extend existing platforms for further dialogue on emerging science, needs of patients, and expectations from all stakeholders to keep up to date with scientific progress and to provide a regulatory environment that is “adequate for innovation based on science centred around patients’ needs.”


After hosting the first international scientific workshop on nanomedicines earlier this month, the European Medicines Agency (EMA) has concluded that further research is needed to provide an adequate scientific basis for evaluating the quality, safety, and efficacy of such medicines.

Nanomedicines in EMA Spotlight

The director-general of the European Generic Medicines Association (EGA), Greg Perry, emphasized the need for European Union biosimilar guidelines for monoclonal antibodies (mAbs), as well as for a harmonized, global approach to biosimilars in general, at the agency’s 8th International Symposium on Biosimilar Medicines last week.

“As regulations fall into place worldwide, there is a need to reach a global agreement on criteria and guidelines for biosimilar medicines in the interest of patients and the better availability of high quality medicines,” said Perry, according to an EGA 

Progress toward biosimilars regulation has been made in several countries outside the EU, including Australia, Canada, Japan, Turkey, and the US. EGA believes the time is fast approaching to undertake a “benchmarking” exercise. “A consistent, scientific global approach is essential to move towards true global development of biosimilars medicines,” said the EGA statement.
  
Steps toward a global, harmonized regulatory approach may already be in sight, with the World Health Organization (WHO) scheduled to finalize its guidelines on the evaluation of similar biotherapeutic products in 2011. According to EGA, the guidelines will be founded on the same basic scientific principles as in the EU.

In particular, Perry highlighted the importance of mAbs at the symposium and the need for “workable” guidance in this area. According to Peter Gaskin, a Principal Consultant at Aptuit Consulting, many companies are already targeting mAbs for biosimilar development. In a recent 

, Gaskin explained that EU guidelines for biosimilar mAbs would be a significant development, particularly because mAbs represent some of the biggest selling products.
  
“If healthcare systems are to continue to function long-term, we must address the importance of biosimilar mAbs next,” said Perry. “Science for mAbs is already here today and our industry is expecting a workable guideline.”

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

Call for "Workable" Guideline for Biosimilar mAbs

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline’s pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder. The vaccine has been used for vaccination against H1N1 influenza in more than 30 million Europeans since September 2009; however, the EMA stresses in a 

 that only a small number of narcolepsy cases have been reported and it is not yet known if the vaccine caused the disorder. Narcolepsy causes a person to fall asleep suddenly and unexpectedly, and its precise cause is unknown.

“The Agency’s Committee for Medicinal Products for Human Use (CHMP) will look carefully at all of the available data to determine whether there is any evidence for a casual association,” said the EMA statement. “As part of this evaluation, the Committee will also consider the so-called background rate for narcolepsy, i.e. the number of cases that would normally be expected to be diagnosed.”

The narcolepsy cases that may possibly be linked to the vaccine were all collected through spontaneous reporting systems, mainly in Sweden in Finland. In particular, Finland observed a rise in narcolepsy cases among children and adolescents, and the Finnish National Institute for Health and Welfare (THL) recommended last week that use of the vaccine be discontinued in Finland until an explanation is found.

“A number of different reasons may be behind the observed rise in the incidence of narcolepsy: A(H1N1) infection, vaccination, a compound effect of infection and vaccination, or some other factor entirely. Infections in general are known to cause narcolepsy,” said a 

According to the EMA, its CHMP will be working with experts across the EU to assess Pandemrix and any potential changes to the vaccine’s benefit/risk balance. The CHMP will also consider the need for any provisional measures at its September 2010 meeting. In Finland, THL experts and pediatric neurologists will also be investigating the matter. The THL has said that it will relay any research results abroad for use in other countries’ vaccination programs. 

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline's pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder.

EMA reviews safety of GSK vaccine

GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd and ProStraken Group plc have been named and publicly shamed for breaching the Association of the British Pharmaceutical Industry’s (ABPI) 

. The code covers the promotion of medicines, including journal and direct mail advertisements, and the provision of information to patients and the public. 

The companies have breached the code in different ways; however, all three stand in violation of Clause 2 of the code: bringing discredit upon and reducing confidence in the pharmaceutical industry, according to a 

 released by the Prescription Medicines Code of Practice Authority (PMCPA), which administers the ABPI Code of Practice.

The case against the pharma giant stems from the company making misleading claims about its smoking cessation aid NiQuitin. The complaint was made by Johnson & Johnson after the company received a mailing promoting the product. The mailing contained the claim “From day one NiQuitin 25mg Clear Patch delivers more nicotine than any other therapeutic nicotine patch”, which was alleged by Johnson and Johnson to be “ambiguous and misleading” primarily because of a lack of clarity relating to the measures of speed and the extent of nicotine delivery upon which the claim was based. 

In response, the PMCPA ruled that the company was in breach of Clause 2, as well as other clauses relating to:

Cephalon breached the code by providing free stock of its breakthrough pain treatment, Effentora (a Schedule 2 controlled drug that is subject to ordering/storage and prescribing restrictions) without “sufficient controls”. According to the code, no more than 10 free samples should be provided but in this instance the company supplied 30. The complaint also attached emails that stated Effentora was supplied as an inducement to prescribe and “assist [Cephalon] with moving forward with a formulary application”. 

Despite an appeal, Cephalon was ruled as breaching Clause 2, as well as further clauses relating to failing to maintain high standards. 

ProStrakan’s breach of the code stemmed from the company making claims about its Abstral that were misleading and did not comply with a previous undertaking. In a previous case (case number: AUTH/2207/2/09), the PMCPA had ruled that a “10 minute pain relief claim” of Abstral was in breach of the code as the product only provided pain relief from 15 minutes after administration onwards. The most recent case draws from a complaint made by Cephalon. According to the company, a revised promotional campaign for Abstral inferred that the product was actually even faster in onset than 10 minutes by using the advertisement heading ‘To hell and back in minutes’. 

The ABPI’s Prescription Medicines Code of Practice Authority (PMCPA) has advertised brief details of all cases in the 

 on 25 August. The full case reports have been published in the PMCPA’s 

GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd and ProStraken Group plc have been named and publicly shamed for breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice.