The United States Food and Drug Administration (FDA) was expected to release interchangeability guidance on biosimilars sometime before December 31, 2016. However, in September 2016, the FDA released a biosimilar user fee reauthorization commitment letter, that stated the agency will issue the draft guidance sometime before December 31, 2017.
Leigh Purvis, director of health services research in AARP’s Public Policy Institute, told Bloomberg BNA in a Sept. 23 e-mail, “Interchangeability will be key to achieving the expected savings from biosimilars. The fact that we’re still waiting on guidance over six years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA)—and that the publication date remains a moving target—is extremely concerning. Patients taking expensive biologic drugs literally can’t afford to keep waiting.”
In the September 16 letter, which includes the agency’s performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2018-2022, the FDA also said that it will work to issue a revised draft or final guidance on interchangeability within two years after the close of the public comment period of the initial draft, which would mean the end of 2019.
All Biosimilars Approved So Far
A biosimilar is a biological product that is approved by the FDA based on a showing that it is highly similar to an already approved biological product, known as a reference product (RP), or brand biologic. The BPCIA, part of the Affordable Care Act, created a streamlined approval process for biosimilars.
On further review by the FDA, the biosimilar can be designated as interchangeable with the RP, which means that a pharmacist could substitute the biosimilar with the RP without a physician’s approval.
Since the BPCIA became law in 2010, the FDA has approved four biosimilars: Sandoz’s Zarxio (filgrastim-sndz), a biosimilar of Amgen’s cancer treatment Neupogen, in March 2015; Pfizer and Celltrion’s Inflectra (infliximab-dyyb), a biosimilar of Johnson & Johnson’s arthritis treatment Remicade, on April 5; Sandoz’s Erelzi (etanercept-szzs), a biosimilar of Amgen’s arthritis drug Enbrel; and Amgen’s ABP 501, to be sold as Amjevita (adalimumab-atto), a biosimilar of AbbVie’s top-selling anti-inflammatory drug Humira, on September 23. None has been designated as interchangeable.
Industry Reaction Favorable Overall
In the September 16 letter, the FDA said it will also publish a revised draft guidance on “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” by September 30, 2018, and will update the current draft or final guidance on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development” by December 31, 2018.
Industry reaction to the letter was generally positive focusing on aspects other than interchangeability.
Pharmaceutical Research and Manufacturers of America (PhRMA) President and Chief Executive Officer Stephen J. Ubl noted, in a September 16 statement, key provisions of the letter, including: continued improvement of the efficiency of the science-based FDA review process for biosimilars; the establishment of dedicated staff capacity for key functions; ensuring the long-term sustainability of BsUFA activities through modernized time reporting and capacity planning; and promoting informative engagement between FDA and biosimilar sponsors during development and review of biosimilar products, for example, by helping to ensure feedback is provided in a timely manner.
Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe said in a statement the same day: “Among the many enhancements to the biosimilars review process envisioned in the goals letter, we are particularly pleased with the Agency’s commitment to establish a program for enhanced communications during the biosimilars review process. A similar program in PDUFA [the Prescription Drug User Fee Act] has been tremendously successful in improving communications between Sponsors and the Agency at key points in the development process, resulting in a more efficient process for sponsors and the FDA alike.”