Bioanalysis Zone

Pfizer’s proposed biosimilar secures approval from FDA advisory committee


Pfizer Inc. (NY, USA) announced yesterday (25 May 2017), that the Oncologic Drugs Advisory Committee has approved their biosimilar epoetin alfa, the first erythropoiesis-stimulating agent that has ever been approved by an FDA advisory committee.

The drug, which works by stimulating red blood cell production, has been recommended for treating anemia caused as a result of: chronic kidney disease, use of the drug Zidovudine in patients with HIV and concomitant chemotherapy. This is in addition to being utilized to reduce the number of red blood cell transfusions for patients undergoing elective surgery.

As stated in the press release, the favorable recommendation from the Oncologic Drug Advisory Committee was on account of the comparable efficacy and safety of the biosimilar to its reference drugs that are currently sold on the market by Amgen (Epogen®)  and Johnson & Johnson (Procit®).

Although the recommendation does not guarantee that the FDA will approve epoetin alfa this recommendation still marks a significant success for Pfizer in the emerging biosimilars industry.

Diem Nguyen, the Global President for Pfizer Essential Health commented that: “The committee’s recommendation reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them.”

She added: “Following the approval and launch of INFLECTRA® (infliximab-dyyb) in 2016, this positive recommendation – a first for a proposed ESA biosimilar – marks an important milestone for Pfizer’s U.S. biosimilars portfolio.”

Source: Pfizer press release:





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