The US Food and Drug Administration (FDA) has withdrawn the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft was intended to provide advice regarding the evaluation of analytical similarity between a biosimilar and a reference product. However, the FDA has withdrawn the draft to give further consideration to the scientific and regulatory issues involved.
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped,” stated FDA commissioner Scott Gottlieb, MD. “I believe that the FDA can do more to support the development of biosimilars, as well as promote the market acceptance of these products.”
Responses to the draft highlighted issues that could affect the cost and efficiency of biosimilar development, including the number of reference product lots that biosimilar developers should sample in their evaluation of high similarity.
“As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain,” stated Dr Gottlieb. “One of the central aspects of biosimilar development and approval is the analytical studies performed to demonstrate that a biosimilar is highly similar to the reference product. We’re taking a fresh look at our draft recommendations for evaluating analytical studies in order to ensure our guidance takes into consideration the most current and relevant science.”
The FDA intends to issue future draft guidance to address potential challenges faced by biosimilar sponsors in designing studies that are intended to demonstrate that a proposed biosimilar product is highly similar to a reference product. Future draft guidance will consider appropriate methods to analyze analytical data to account for potential lot-to-lot variability of the reference product.
“We’ll continue to work directly with biosimilar developers on their programs as we develop new draft guidance in this area,” Dr Gottlieb concluded. “By supporting the more efficient development of biosimilars over the long term and helping reduce barriers to bringing these products to market, we can help ensure patients get access to affordable, safe, and effective treatment options.”
The agency will announce when new draft guidance is issued for the evaluation of analytical data between a biosimilar product and a reference product.
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies [press release]. Silver Spring, Maryland: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm611409.htm. Published June 21, 2018. Accessed June 21, 2018.