Regulatory approach to biosimilar development

Biosimilars/Research | Posted 20/05/2011 post-comment0 Post your comment

Legislation in Europe in 2004 created a legal pathway for approval of biosimilars and the first biosimilar, Omnitrope (somatropin) as approved by the EMA in 2006. The US is lagging behind somewhat, having only just approved a legal pathway in March 2010 and with practical guidance from the FDA still anticipated.


Dr Mark McCamish and Dr Gillian Woollett discuss the different regulatory approaches to biosimilars [1].

The EU already has general guidelines for biosimilars covering principles and biotechnology derived proteins as well as quality and safety/efficacy guidelines. Product class specific guidelines are also in place covering human insulin, somatropin, human growth hormone, erythropoietins, interferon-alpha and low molecular weight heparins, see EU guidelines for biosimilars. The EMA is also currently working on concept papers/draft guidelines for a number of other product class specific guidelines, including monoclonal antibodies, interferon-beta and follicle stimulation hormone.

Due to the success of the EU approach the FDA has been urged to use the same approach to approval of biosimilars. However, the authors believe that it is unlikely that the FDA will adopt the EU biosimilars guidelines, despite the fact that it could save time and resources, leaving the FDA to concentrate on interchangeability.

The authors estimate that developing a biosimilar for highly regulated markets, such as the EU and US, costs between US$75 and 250 million. This cost is prohibitive for many small companies that will lead to only a few major players dominating the biosimilars market.

In developing markets, however, the need for biologicals at affordable prices has led to less rigorous regulatory requirements for biologicals targeting the same molecule or disease without a need for demonstration of biosimilarity. These ‘alternative’ biologicals may, according to Dr McCamish and Dr Woollett, be used to discredit true biosimilars.

In the EU biosimilars must ensure the same quality, safety and efficacy, as any other product, along with demonstrating biosimilarity with the reference product. Extrapolation of the biosimilar to multiple indications is also possible in the EU after demonstration of comparability, and equivalent safety and efficacy in at least one indication of the reference product and presumption of a common mode of action.

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1. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-17. doi:10.4161/mabs.3.2.15005

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