Did you know that Biosimilar MS% in EU countries was on the rise?
Some of the reasons behind the same can be outlined as follows:
Between 2011 and 2015 a total of US$17 billion worth of sales in the US alone will lose patent protection, presenting a huge opportunity for biosimilar manufacturers to gain market share.
US patent expiries by market volume based on 2007 US retail sales
From the EMA-
EMA announced on 17 November 2011 that it has published a concept paper asking for comments on topics to be included in a revision of the agency’s 2005 overarching guideline on similar biological medicinal products. The paper will be released for a three-month consultation period. EMA wants to update its overarching guideline on biosimilar drugs to reflect the growing complexity of biosimilar products and unique issues concerning their development.
Since the original overarching biosimilars guideline came into effect in October 2005 several biosimilar products have come onto the EU market, the number of scientific advices given by EMA’s Committee for Human Medicinal Products on the development of biosimilar products has increased significantly, and the regulatory framework is becoming wider, e.g. addition of the guideline for biosimilar monoclonal antibodies.
Therefore, due to the development of more complex biosimilars, EMA has proposed a list of several topics for re-evaluation. These include:
Explaining the principles of biosimilarity in a clearer way
Defining the term ‘biosimilar’ more clearly (numerous terms are in use for ‘biosimilar’ or ‘similar biological medicinal product’, and often the term ‘biosimilar’ has been used in an inappropriate way)
Discussion of the feasibility of following the generic legal basis for some biological products
Re-discussion and potential refinement of some more specific aspects, e.g. should discussion of equivalency of safety and efficacy not be covered by the revision of the general non-clinical and clinical guideline Further discussion is needed to clarify if in exceptional situations, e.g. where a very simple biological fully characterized on the quality level, a biological medicinal product could be authorized based on a bioequivalence study only combined with an extensive quality comparability exercise.
EMA expects a draft revised guideline to be released in the first quarter of 2012 after a feedback is submitted till Feb 2012.