FDA nixes Pfizer’s Epogen biosimilar and requests a fix

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For the second time in 2017, Pfizer has received a disappointing letter about its progress toward FDA approval for a biosimilar product similar to the drug Epogen. The root of the problem lies with manufacturing facilities that may produce the biosimilar, not with the safety or biosimilarity to Epogen, Pfizer notes.

In February 2017 Pfizer received a letter from the FDA that warned about particulate matter (cardboard) in some batches of other drugs manufactured in its facility in McPherson, KS, in 2016. The company responded by taking steps to address the concerns.

On May 25, Pfizer received good news: the FDA Oncologic Drugs Advisory Committee (ODAC) voted to recommend the company’s proposed biosimilar for approval. “The ODAC’s recommendation was based, in part, on the FDA’s briefing materials, which concluded that proposed biosimilar epoetin alfa is highly similar to its reference product, Epogen and Procrit (epoetin alfa), and supports a demonstration that there are no clinically meaningful differences in terms of the safety, purity and potency of the product,” Pfizer said.

Regarding the reference product for the biosimilar, a generic form is not yet available. Epoetin is manufactured and marketed by Amgen as band name Epogen. Johnson & Johnson subsidiary Janssen Biotech sells the same drug under the name Procrit, per a product license agreement.

Pfizer announced in late June, however, that it had received an FDA Complete Response Letter (CRL) about the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in the FDA’s original warning letter issued in February, following a routine agency inspection of Pfizer.

“The issues noted in the Warning Letter do not relate specifically to the manufacture of epoetin alfa,” Pfizer wrote in its announcement about the CRL. “This facility was listed as the potential manufacturing site in the BLA (Biologics Licensee Application) for the proposed epoetin alfa biosimilar.”

Fierce Biopharma reported that “the agency couldn’t approve the biosimilar because the potential manufacturing site in the BLA for the biosimilar was “the same Hospira unit plant which was responsible for an FDA rejection of Glatopa, the highly anticipated long-lasting generic version of Teva’s Copaxone.”