FDA Withdraws Draft Guidance on Biosimilars

The U.S. Food and Drug Administration (FDA) withdrew its 2017 draft guidelines on biosimilars in response to the unexpectedly slow pace of biosimilar development and distribution. In a press release announcing this decision, the FDA said it will work with industry to create new guidance that will reduce barriers to bringing biosimilars to market.

A product is considered a biosimilar if it is similar but not identical to a biologic already approved by the FDA. The 2017 document, “Statistical Approaches to Evaluate Analytical Similarity,” was intended to provide advice for analyzing similarity between biologics and proposed biosimilars.

However, rather than spurring the creation of new biosimilars, the FDA has seen the number of drugs in development fall in recent years, from 69 in 2016 to 59 in 2018. Future draft guidance will recommend analytic methods for ensuring a product’s biosimilarity over time and will be crafted to provide sponsors with increased flexibility in developing biosimilar products, without compromising the FDA’s scientific standards.

FDA Commissioner Scott Gottlieb, MD, expressed disappointment with the current pace of biosimilar development, but vowed to create a friendlier environment for the development of the vital drugs. “By supporting the more efficient development of biosimilars over the long term and helping reduce barriers to bringing these products to market,” he said, “we can help ensure patients get access to affordable, safe, and effective treatment options.”

Sources: STAT News, June 21, 2018; FDA press release, June 21, 2018.