Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

Back in December of 2020, then-president Trump signed into law the “Consolidated Appropriations Act, 2021.”. Included within this omnibus legislation are several provisions that affect the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Here’s everything you need to know about these new amendments:

#1 Label updates. The new Section 530D creates a process by which the FDA is able to determine whether it would benefit the public health to update the generic drug labeling at any point after the brand reference-listed drug is withdrawn for reasons other than safety or efficacy, meaning commercial reasons. The FDA can use this process for drugs when there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling or the approved labeling does not reflect current legal and regulatory requirements for content or format. The FDA can also update the label if there is a relevant accepted use in clinical practice that is not reflected in the approved labeling. 

#2 Orphan Drug Clarification. FDA has always taken the position that it will not grant orphan exclusivity to a drug product with the same active moiety as a previously approved product that has an orphan designation for the same use unless the sponsor shows the new product is “clinically superior” to the existing product. Now, Congress responded to adverse judicial decisions by embracing the FDA’s clinical superiority requirement. The 2021 Appropriations Act amendment says that FDA Reauthorization Act of 2017 (FDARA)’s clinical superiority requirement does apply in a circumstance where drugs received an orphan drug designation pre-FDARA but were approved for marketing post-FDARA.

#3 Biosimilar Provisions. The Act includes two provisions relevant to applications to license biosimilar products. An abbreviated Biologics License Application (aBLA) contains evidence that the potential drug is biosimilar to a reference product already approved by the FDA. Section 322 of Division BB permits but does not require aBLAs to include information to show that the biosimilar’s conditions of use are the same as conditions of use approved for the reference product. Section 325 of Division BB, entitled “Biological Product Patent Transparency,” requires additional disclosures of information related to biological products. Specifically, it requires that within 180 days, the FDA will create a searchable, electronic list of licensed biologics and update that list monthly. This list must include in its exclusivities and patent information, which every reference product sponsor that sends a list to a biosimilar applicant must now share with FDA within 30 days after sending it to the biosimilar applicant.

Don’t hesitate to contact us with any questions regarding how this affects your company and your products. Don’t try to handle these new amendments on your own. Bring in professional FDA attorneys!

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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