FDA Advances Biosimilar Approvals

The biologics market has been lacking effective competition over the years, partially because of regulatory review processes. In 2010, Congress gave FDA the authority to implement an abbreviated approval pathway for biosimilars and interchangeable biological products, and FDA has made a concerted effort since then to support a market for safe and effective biosimilars.

In a press statement, Sarah Yim, MD, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, announced that the agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, was among nine biosimilars approved so far in 2019, bringing the total of approved biosimilars to 25.

“I’m pleased to see this progress and am confident that the market for these therapies will continue to grow. To date, 74 programs for 38 different reference products have been enrolled in our Biosimilar Product Development Program to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace,” Yim stated.

According to Yim, the agency is working to improve the efficiency of its approval processes for biosimilars, including development of new biosimilar-specific review templates and development and validation of pharmacodynamic biomarkers tailored to biosimilar development. In addition, in March 2020, the agency will be transitioning approval of biologics marketing applications regulated under the Federal Food, Drug, and Cosmetic Act to be approved as biologics license applications regulated under the Public Health Service Act, which would make these products open to biosimilar competition. 

Source: FDA