Monday, January 26, 2015

U.S. Biosimilars drugs in 2015, What to expect, catch-up with European Union ?

The FDA Oncologic Drugs Advisory Committee unanimously recommended approval of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments that deplete these necessary infection-fighting cells. If FDA-approved, this would be the first true biosimilar in the U.S. and would have a brand name of Zarxio. The FDA noted in their briefs that EP2006 was “highly similar” to the brand biologic and had “no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity, and potency”. The FDA stated that “robust” pharmacokinetic and pharmacodynamic comparative studies supported biosimilarity with the original filgrastim. Legal action over patent protection may still interfere with a launch any time soon.
Biosimilars are just that; similar because they do not have to be exact copies of the active ingredient, as with small-molecule drugs. The Biologics Price Competition and Innovation Act of 2009 (the BPCI Act) allowed the creation of an abbreviated licensure pathway for biological products that are shown to be interchangeable with an already FDA-approved biological product. Under the new law, a biological product may be demonstrated to be “biosimilar” if data show that the product is “highly similar” to an already-approved biological product.

Several biologics have already lost patent protection in Europe. An established legal pathway for biosimilars has been in the European Union since 2005. Several biosimilars, including somatropins, filgrastims, and epoetins, have been licensed and marketed in the European Union (EU). Biologics that have already expired in Europe include Neulasta (pegfilgrastim), Remicade (infliximab), Mabthera (rituximab, known as Rituxan in the U.S.), and Lovenox (enoxaparin).
Other top biologics facing future patent expiration include Humira (2018), Enbrel (2015), and Avastin (2019), all well-known brands in the U.S. According to IMS, the biologics market accounts for 27% of the pharmaceutical sales in Europe and is growing at 5.5% vs. total market growth of 1.9% between 2012 and 2013.
France was the first EU member-state to initiate automatic pharmacist substitution for biosimilars in February 2014.

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