A follow-on biological drug is not a biogeneric: Lessons from Omnitrope and Valtropin
Journal of Generic Medicines, Volume 6, Number 3, May 2009

Robert I. Roth, M.D., Ph.D., Medical Director, and Nicholas M. Fleischer, Ph.D., Vice President

Recent years have seen the approvals, more so in the EU than the United States, of follow-on biological drugs. These products have been new formulations of recombinant therapeutic proteins, developed to compete with the marketed originator products. Intended to closely mimic the originator products in terms of chemistry and therapeutic properties, these so-called 'biosimilar' products were initially conceived to be developed according to abbreviated development programmes, presumably at a substantial cost savings to both the drug developer and the consumer. With several such products now recently approved, however, it has become clear that their development programmes have been quite extensive and not particularly abbreviated. Accordingly, cost savings to consumers appear to be relatively modest.

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