While biosimilar products have been commercially available in Europe for nearly a decade, the U.S. FDA in March 2015 approved its first biological product demonstrated to be biosimilar to, or interchangeable with, an already licensed biological product.
Until recently, the regulatory pathway for obtaining a biosimilar approval in the U.S. wasn’t even defined. However, the 2010 amendment to the Public Health Services Act established that long sought route. Last July, Sandoz announced that FDA had accepted their 351(k) BLA for EP2006, a proposed biosimilar to Neupogen® (filgrastim). Adding to the good news, in January 2015 FDA’s Oncologic Drug Advisory Committee (ODAC) voted 14-0 in favor of approving EP2006. And on March 6, 2015 FDA announced the approval of the first U.S. biosimilar, branded as Zarxio.
So what does this all mean? Although future biosimilar evaluations may not be as easily or unanimously decided upon as Zarxio (largely due to real-world clinical experience and the product’s existing approvals in 40+ countries), the onslaught of biosimilars is certainly soon to be upon us. With precedence soon to be established and valuable FDA and Industry experience gained, it can’t be long before we begin reading announcements of successful 351(k) BLA filings for biologics blockbusters such as Humira®, Enbrel®, Procrit®, and Remicade®.
Senior Vice President, Head of Regulatory Consulting