US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, has announced the release of the FDA’s Biosimilar Action Plan to promote competition and affordability across the market for biologic and biosimilar products.
“Preserving that balance between innovation and competition requires modernizing regulatory requirements to maintain efficient, predictable and science-based pathways for drug review,” Dr Gottlieb stated. “Our aim is to reduce the time, uncertainty and cost of drug development, while also supporting a competitive market through the efficient approval of lower-cost generic, biosimilar and interchangeable alternatives after the expiration of patents or other statutory exclusivities.”
Dr Gottlieb noted that although fewer than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs. In addition, biologics represent 70% of drug spending growth from 2010 to 2015. To make sure that new treatment breakthroughs remain affordable, the market requires competition from biosimilars.
The FDA’s Biosimilar Action Plan aims to accelerate biosimilar competition with 4 main strategies:
- Improving efficiency of the biosimilar and interchangeable product development and approval process
- Maximizing scientific and regulatory clarity for the biosimilar product development community
- Developing effective communications to improve understanding of biosimilars among patients, providers, and payors
- Supporting market competition by reducing attempts to unfairly delay market competition of follow-on products
As part of the FDA’s effort to bring high-quality biosimilars to market, the agency is working to strengthen partnerships with regulatory authorities in Europe, Japan, and Canada to enable greater efficiency in developing safe and effective biosimilars.
The FDA has also issued its final guidance on biosimilar labeling to ensure that biosimilar products have labeling that allows healthcare practitioners to make informed prescribing decisions for their patients.
Dr Gottlieb also noted that the agency is currently developing and implementing new FDA review tools, such as standardized review templates, that are tailored to applications for biosimilar and interchangeable products. The agency is also developing an index of biosimilars’ critical quality attributes relative to their reference products, which will allow sponsors to better understand how the FDA evaluates data from comparative analytical studies to support biosimilarity.
“Effective market competition from biosimilars depends on additional actions from our public and private sector partners to align reimbursement and formulary design to encourage appropriate biosimilar adoption,” Dr Gottlieb concluded. “Competition requires all of us to shine a light on the anti-competitive impact of tying rebates and bundling biologics with other products to protect biologics’ market share. And it requires us to educate providers and patients about biosimilars, and why people should have confidence in the safety and effectiveness of these FDA-approved products.”
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan [press release]. Silver Spring, Maryland: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613881.htm. Published July 18, 2018. Accessed July 19, 2018.