Pfizer’s biosimilar gets a second knock-back from FDA

Pfizer has been dealt a stinging blow by the FDA, after it received a second complete response letter from the Angecy regarding its biosimilar for Amgen’s Epogen. All of the signs seemed to point towards a straight-forward approval, after an advisory committee voted overwhelmingly in favour of the biosimilar yet it stumbled on manufacturing issues.

In particular, the rejection related to Pfizer’s fill-finish plant in McPherson, Kansas. The facility had already received a warning letter, issued on 14 February of this year, so the CRL should not have come as a complete surprise to the company.

The company released a statement explaining the rejection: "This CRL relates to matters noted in a Warning Letter issued on February 14, 2017 following a routine Agency inspection of the company’s facility in McPherson, Kansas in 2016. This facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar. The issues noted in the Warning Letter do not relate specifically to the manufacture of epoetin alfa. No additional clinical data was requested in the CRL at this time to support a future approval."

The latter part of the statement is of little surprise, as the FDA’s advisory committee had given the drug a 14-1 vote of approval. The plant itself was purchased as part of the 2015 $17 billion deal for Hospira but there have been numerous warnings from the FDA that the manufacturing network it picked up as part of the deal were not up to scratch.

The rejection will come as a bonus to Amgen, as its blockbuster drug will be protected, at least in the short-term, from a rival stealing a swathe of its drug’s market. Epogen is used to treat those with a lower than normal level of red blood cells caused by chronic kidney disease. Last year, it garnered the company $1.3 billion in sales.