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FDA announced the provision of final guidance on “interchangeable” biologics on 10th May 2019, aiming to promote competition in the biologics market. The document will provide clarity for biological product developers on whether they meet the criteria for statutory interchangeability standard under the Public Health Service Act (PHS Act).

The final guidance provides an overview and scientific recommendations required for licensing an application or supplement as an interchangeable biologic product, subject to statutory standard for approval.

In addition to the final guidance document, FDA is developing a Biosimilars Action Plan to encourage biosimilars innovation and increase competition for biologics in the market.

According to the statement, FDA is seeking build a solid regulatory framework to help developers license proposed biosimilars and interchangeable products under the relevant regulations. This could eventually lead to reducing drug costs for patients in the long run. (Source)

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