Despite the fact that there are at least 5 biosimilar products with review timelines scheduled to come up for FDA review this year, and several previously rejected applications that could also be in line for review, 2017 may turn out to be a year that will be regarded as “a lull” in biosimilar approvals and marketing in the United States.1 This will further delay the development of a robust competitive environment with multiple biosimilars of the same reference product, which could potentially result in meaningful price reductions and improved access to important, expensive medications.
The FDA faces a year of changes and unknowns in 2017. There is a March 20 deadline for public comments on the agency’s recently released draft guidance on biosimilar interchangeability—a designation considered key to the long-term success of biosimilars—but it is not known when (or if) the FDA will make any such interchangeable designations. Another regulatory issue facing the FDA is the need to renew the Biosimilar User Fee Act (BsUFA) program, which expires September 30, 2017. The BsUFA must first be approved by Congress and the Trump Administration before it takes effect. A renewed BsUFA agreement would provide a huge funding boost for biosimilar regulation and review activities, potentially improving FDA’s capacity for much-needed guidance development and educational initiatives for biosimilars.
In addition, several federal court decisions that will be made in 2017 are expected to have a great impact on US biosimilar approvals. The Supreme Court will rule on the Amgen-Sandoz Zarxio dispute over patent information exchange and biosimilar launch provisions in the Biologics Price Competition and Innovation Act (BCPIA). Additional hearings and trials for several other patent cases involving reference pharmaceuticals and biosimilars will affect whether new biosimilars will reach the US market this year. There are also reported to be a large number of BPCIA litigations that promise to be complex and continuing: one is AbbVie’s suit against Amgen over alleged infringement of Humira (adalimumab) patents that will potentially slow any launch of Amgen’s adalimumab biosimilar Amjevita, and the other is Amgen’s patent litigation against Novartis/Sandoz’s Erelzi (etanercept), an Enbrel biosimilar.
Finally, hanging over all of these issues is the possibility that the changes promised by the Trump administration with respect to repealing and replacing the Affordable Care Act (ACA) will affect the BCPIA, which was enacted in 2010 as part of the ACA. There are also questions about the administration’s federal hiring freeze and whether it will affect the FDA’s user fee-funded positions that affect drug approvals and review.