Lexology October 30, 2025
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES) to demonstrate biosimilarity in an abbreviated biologics license application (aBLA). This approach could significantly lower the cost of bringing biosimilars to market.
Though promising, there remains uncertainty about how the FDA will apply its new policy. Whether a CES will be required is largely a product-specific determination that will require engagement with the Agency early in development. In addition, what types of immunogenicity studies that the FDA may require is an open question. For example, the FDA could demand a full switching study which is costly, time-consuming, and generally used to obtain an interchangeable designation. Manufacturers will...
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