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Working the biosimilar boom


As the next wave of patent cliff expirations erode into the balance sheets of the largest healthcare firms, biosimilar manufacturers will be handed huge opportunities. However, there are still many grey clouds hanging over the manufacture of biosimilars, both in terms of legislation and commercialisation. Maribel Rios of BioProcess International looks into this complex topic.


The 2009 Biologics Price Competition and Innovation Act (BPCIA) provided the bioprocessing industry with the legislative pathway toward approval of biosimilars in the US. The US Food and Drug Administration information regarding how it will translate that legislation was limited, however, until FDA leadership published an August 2011 article in the New England Journal of Medicine. As expected, the agency appears to be implementing a science-driven approach, with sponsor companies needing to apply complementary, orthogonal analytical methods to present a "totality of evidence" required to verify "sufficient similarity".

Already, the industry had some ideas of the requirements and specifications that might pertain to biosimilars. The International Conference on Harmonization (ICH) finalised a quality guideline for biologics test procedures and acceptance criteria back in 1999. And the European Union published general biosimilar guidance in 2005 and has since released others for specific biologic types. Current perspectives on biosimilars manufacture, process development, testing, and emerging markets continue to be hot topics of discussion.

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