FDA approves first ‘biosimilar’ drug, boosting competition

The Food and Drug Administration on Friday approved the first “biosimilar” drug in the United States, in a move that is expected to increase competition and lower prices in the drug market. 

{mosads}A biosimilar drug is the equivalent of a generic drug in that it copies an existing brand-name medication. But unlike generics, biosimilars are not exact copies. They are imitating much more chemically complex drugs that cannot be easily copied and come from living organisms, which makes them more unpredictable. 

That makes the approval process more difficult, so the FDA decision is a milestone. It approved Zarxio — made by Sandoz, a subsidiary of Novartis — a biosimilar to Amgen’s Neupogen. The drug is used to increase white blood cells in people undergoing chemotherapy. 

“Biosimilars are likely to create greater competition in the medical marketplace,” Leah Christl, the FDA’s associate director for therapeutic biologics, said in a statement. 

The pathway for approving biosimilars was eased by ObamaCare, which included a measure easing the licensing process. 

The FDA reviews evidence to ensure that the biosimilar has the same effects as the original drug. 

“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret Hamburg said in a statement. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”