"The U.S. Food and Drug Administration (FDA) announced on Wednesday that it will be making it easier to develop biosimilar drugs in its ongoing effort to lower drug prices. The agency published draft guidance yesterday that recommended relaxing the requirements "to support a demonstration of biosimilarity in a biologics license application (BLA) submitted under section 351(k) of the Public Health Service (PHS) Act.""
"If a CAA shows that "the proposed biosimilar is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity may be sufficient to evaluate whether there are clinically meaningful differences between the proposed biosimilar and the reference product in terms of safety, purity, and potency," said the guidance. In this case, "FDA recommends that sponsors consider a streamlined approach where a CES may not be necessary to support a demonstration of biosimilarity.""
FDA published draft guidance recommending relaxed evidentiary requirements to support biosimilarity in 351(k) BLAs, aiming to reduce unnecessary clinical testing and accelerate lower-cost biosimilars. The guidance identifies comparative analytical assessment (CAA) as generally more sensitive than comparative efficacy studies (CES) and advises sponsors to carefully consider which studies to use. Where CAA demonstrates high similarity, an appropriately designed human pharmacokinetic similarity study and immunogenicity assessment may suffice to evaluate clinically meaningful differences in safety, purity, and potency. The guidance outlines manufacturing and quality-attribute conditions under which a streamlined approach without CES should be considered.
Read at IPWatchdog.com | Patents & Intellectual Property Law
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