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Pfizer gets FDA panel recommendation for biosimilar EPO

Product could be the first direct competitor to Epogen and Procrit in the US


Pfizer's emerging biosimilar business got another boost yesterday after an FDA advisory committee recommended approval of its version of red blood cell stimulator epoetin alfa.

Pfizer's drug is the first biosimilar of an erythropoiesis-stimulating agent (EPA) to reach this stage of registration in the US, although biosimilar epoetin drugs have reached the market in Europe and other world markets.

Pfizer is seeking approval for its biosimilar for the treatment anaemia caused by chronic kidney disease (CKD), HIV drug zidovudine and cancer chemotherapy, as well as to reduce the need for red blood cell transfusions in some patients undergoing surgery. If approved it will also be sold by Vifor Pharma in the US dialysis market.

If the FDA follows its panel's advice – which it generally does – Pfizer will have a direct competitor to Amgen's Epogen and Johnson & Johnson Procrit blockbuster brands in the US. The US agency previously turned down the biosimilar, which was developed by its Hospira unit and has been dubbed Retacrit, in 2015.

"The committee's favourable recommendation was based on its review of the totality of evidence, including demonstration of comparable efficacy and safety of biosimilar epoetin alfa to its reference product," said Pfizer in a statement.  Amgen reported Epogen sales of $1.3bn last year – all from the US market – while Procrit earned $1.1bn for J&J, including $767m from the US.

Epogen shrank by a third last year thanks in part to switching of some patients to Amgen's long-acting ESA Aranesp (darbepoetin alfa) and competition from Roche/Vifor's Aranesp rival Mircera (methoxy polyethylene glycol-epoetin beta) which launched in the US in 2015, and the approval of Pfizer's biosimilar would put greater pressure on the brand.

Amgen filed a lawsuit against Hospira last year in an attempt to keep the biosimilar off the market, claiming its drug infringed its patents and that Hospira had not followed correct biosimilar procedures, specifically notifying of its intention to commercialise the drug after the FDA accepted its marketing application. The notification –which kicks off a 180-day stay on a launch – should only kick in after FDA approval, claims Amgen.

If approved, the epoetin alfa biosimilar would be Pfizer's second in the US, after it got the go-ahead from the FDA to sell Inflectra (infliximab-dyyb), a biosimilar of J&J's Remicade, last year.

"This positive recommendation – a first for a proposed ESA biosimilar – marks an important milestone for Pfizer's US biosimilars portfolio," commented Diem Nguyen, global president, Americas, for the company's Essential Health division.

Article by
Phil Taylor

26th May 2017

From: Regulatory



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