Payers' Forum Europe

Oct 21, 2013 - Oct 22, 2013, Berlin, Germany

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EMA Releases Final Guidance on Biosimilars, Seeks Comment

The EMA has released the last of a series of three proposed guidelines on biosimilar medicines for public six-month consultation.



The latest document sets out the EMA’s current position regarding both clinical and non-clinical development requirements for biosimilar copies of medicines which have lost patent protection, providing an update to earlier guidance released in 2006.

Since 2006, the EMA says that “14 biosimilar medicines have received marketing authorisation in the EU”; the agency also notes that the number of applications being processed by its Committee for Medicinal Products for Human Use (CHMP) has risen substantially in this time.

The efforts towards defining regulatory pathways for biosimilars have been necessitated by a change in the market, as many of the early generation of biologic drugs are coming off patent. Biosimilars demand different, more stringent assessment than generic versions of chemical medicines as biologic drugs cannot be exactly replicated; because biosimilars are not exact copies of the original biologic, regulators need to ensure safety and efficacy are not compromised. The EMA’s attempts to refine the process of approving biosimilar drugs will be seen as imperative for many governments struggling to afford the high prices of patented biologic medicines.

A report by market research firm Visiongain predicts that the market for biosimilars is set to grow rapidly in the next decade, with this year alone seeing a 20% gain from last year, taking the total value of the market up to $2.44 billion. Currently the leading segments in this market are monoclonal antibodies, insulins, interferons, erythropoietin, growth hormone and follicle stimulating hormone (FSH). The loss of patent protection for many biologics will be the main driver for growth in this area.

The latest guidelines to be released deal with factors emerging since 2006, including the move towards risk-based approaches for non-clinical studies, and the practice of using pharmacodynamic markers to demonstrate clinical comparability. It also covers issues surrounding patient selection and surrogate endpoints, extrapolating efficiency and safety from one therapeutic indication to another, and designing immunogenicity studies. The two other guidelines included a document on the general principles regarding the demonstration of biosimilarity, which was released last month for comment, and a document discussing quality issues for biosimilars published in May 2012.

The US is currently also working on the details of the regulatory pathway for biosimilars. The Biologics Price Competition and Innovation Act (BPCI) mandated the development of such a pathway, and recently the FDA released its fourth guidance document intended to set out what the regulatory body requires from the developers of biosimilars.



Payers' Forum Europe

Oct 21, 2013 - Oct 22, 2013, Berlin, Germany

Engage with NHS, HAS, G-BA, AIFA, Spain and more to understand what Payers and HTAs want to enable you to create Value Adding Propositions