FDA Statement Marks Approval of 25th Biosimilar Product

November 25, 2019

Biosimilars Team

The recently approved Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab), is one of nine new biosimilar products the FDA has taken action on in 2019 and the 25th biosimilar approved in the United States.  In a statement recognizing this milestone, Sarah Yim, MD, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, expressed confidence “that the market for these therapies will continue to grow.”

Importantly, Yim stated, health care professionals and patients can be confident when using an FDA-approved biosimilar product. Biosimilar products approved by the FDA undergo a rigorous evaluation to determine that they meet the requirements for licensure and are manufactured under the same quality standards as brand name medicines.

Yim cited the following examples of the agency’s ongoing efforts to “support a market for safe, effective biosimilar products”:

  • Continuing the agency’s work under the Biosimilars Action Plan to improve the efficiency of the biosimilar and interchangeable product development and approval process. This includes efforts to develop and implement new biosimilar-specific review templates and progress towards the development and validation of pharmacodynamic biomarkers tailored to biosimilar development.
  • Facilitating the March 23, 2020, transition of approved marketing applications for biological products regulated under the Federal Food, Drug, and Cosmetic Act to be approved biologics license applications regulated under the Public Health Service Act (PHS Act). This means that these biological products—including products like insulin—will be regulated under the PHS Act like other biological products and open to biosimilar competition. This, in turn, could lead to the development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness.

In conclusion, Yim noted that “the promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.”