In a move that could help open the U.S. market for biosimilars, a U.S. Food and Drug Administration subcommittee recently greenlighted Pfizer Inc.’s epoetin alfa compound, an emulation of two medicines designed to relieve anemia in patients who have cancer and kidney disease.
The New York City-based drug manufacturer said in a release its epoetin alfa compound, biosimilar to Epogen and Procritn, has been shown in testing to rival those name-brand equivalents.
Diem Nguyen, Pfizer Essential Health’s global president for the Americas, said in the release the advisory panel’s preliminary approval brings the company to closer to reaching the domestic market.
“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,” Nguyen said in the release. “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.”
According to a Feb. 6, 2015, issue of Fortune magazine, biosimilars are drugs with the same action as name-brand medicine, but unlike generics, they aren’t carbon copies of the original. The Fortune article said Pfizer had invested $17 billion to acquire Hospira, a smaller firm focused on biosimilars.
Anemia results in patients with compromised kidney function, suffer with HIV, or have undergone chemotherapy, the release said.