Biosimilars In 2017: Crowded US FDA Review Queue, Key Legal Decisions

At least five biosimilars could gain US licensure in the coming year on first-cycle review, including subsequent competitors to Remicade and Humira; however, patent litigation is expected to increase and will continue to slow the march of products from FDA approval to commercialization.

The US FDA’s frenetic pace of regulatory activity in the Obama Administration’s waning days may raise concerns that agency efforts to implement the biosimilar approval pathway could hit a lull in the coming months.

However, the 351(k) application workload currently at the agency and the pending reauthorization of the biosimilar user fee program, coupled with some key court decisions anticipated in biological patent disputes, suggests

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