First Biosimilar Product Cleared in European Union

Sandoz, the generics subsidiary of Novartis, has received approval for its Omnitrope human growth hormone product, a copycat version of Pfizer's Genotropin, making Sandoz the first company to win approval of a biosimilar in the EU. The Australian Therapeutic Goods Administration approved Omnitrope in September 2004, and the product has been on the Australian drug market since November 2005. The challenge in regulating biosimilars, in contrast to chemically synthesized drugs, has been in establishing quality standards for bioequivalence. Biologics produced by different processes will differ in secondary, tertiary and quaternary structure or post-translational modification patterns. These differences may affect the safety and efficacy of the biosimilar relative to the pioneer drug. Health Canada is currently considering guidelines for biosimilar products. As the first generation of biopharmaceutical patents expires, these guidelines have become increasingly important to allow for the marketing of follow-on products. Omnitrope was approved under the new EU regulatory framework by the European Medicines Agency (EMEA), which has established guidelines for the approval of biosimilars based on the principle of a "comparability exercise." The framework allows biosimilars to be approved without a full application package, providing studies have show that they have the same basic safety and efficacy profile as the pioneer drug. This will put additional pressure on the US Food and Drug Administration (FDA) to finalize its regulatory framework for biosimilars. Last month, a federal Court ordered the FDA to move ahead with setting out a clear regulatory framework for biosimilars in the US market. The order was a result of a suit brought by Sandoz against the FDA, when the Agency was unable to reach a decision after spending two years on the Omitrope drug application. The Court also ordered the FDA to deliver a verdict on the application. The FDA said it had completed its review in 2004 but had deferred ruling on the application until it has finalized its own guidance on biosimilars. For the EMEA guidelines, see: http://www.emea.eu.int/index/indexh1.htm For commentary on Sandoz's suit against the FD, visit: http://www.pharmatimes.com/news/180406d.aspx?src=PTNews-19-4-2006-3 Summary by: Katharine McGinnis