FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

FDA Citizen Petition Tracker  •  Labeling

As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA to impose stricter labeling requirements on biosimilar applicants. Last month, the Generic Pharmaceutical Association (GPhA) submitted a comment in opposition to the PhRMA/BIO petition.

FDA has now issued an interim response to the joint petition, indicating that “FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials.” FDA states that it will respond to the petition as soon as it reaches a decision, without further elaboration.

FDA’s interim response is essentially the same as its previous interim responses to citizen petitions regarding biosimilar labeling filed by AbbVie and UAW Retiree Medical Benefits Trust.

Stay tuned to the Big Molecule Watch for further developments.

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