3. Big week for biosimilars

The FDA’s advisory committee had a busy week last week recommending approval for two separate biosimilar products, both of which received unanimous support.  Amgen’s proposed biosimilar for AbbVie’s Humira, ABP 501, received a nod from the committee while Sandoz’ etanercept got a thumbs up as a biosimilar to Amgen’s Enbrel.  With consumers demanding lower drug prices and pharma fighting for longer exclusivity, marketing these biosimilars is another discussion…at least in the US.  These reference products are still under patent in the US, but the EMA has already accepted Sandoz’ Marketing Authorization Application and Amgen just struck a deal with Daiichi Sankyo to begin commercializing ABP 501 and eight other biosimilars in Japan.