FDA Approves First Biosimilar Product, Could Be Step Towards Cheaper Medicines
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Ingram Publishing/Thinkstock(NEW YORK) — The U.S. Food and Drug Administration on Friday approved the first biosimilar product for use in the U.S., potentially paving the way for cheaper medicine.
Once a drug’s patent expires, other manufacturers are able to make generic equivalents to a name-brand drug. One class of medications, however, biologics, do not have generic equivalents, as they are not made with chemicals, but instead are produced by or extracted from living cells. Some of these drugs, such as Enbrel, Humira and Neulasta, are among the most expensive drugs on the market.
The FDA hopes to create a path to licensing drugs that act similarly to biologics. On Friday, the agency approved Zarxio, made by Novartis, which will act similarly to Amgen’s Neuprogen.
Neuprogen was first licensed in 1991. Zarxio is approved for the same uses as Neuprogen, which include patients with cancer receiving myelosuppresive chemotherapy or undergoing bone marrow transplantation and patients with severe and chronic neutropenia, among other uses.
“Biosimilars will provide access to important therapies for patients who need them,” FDA Commissioner Margaret Hambrug 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.”
Biosimilars can only be approved by the FDA if they match the reference product in how it works, how it is administered and dosage forms and strengths, and only for the same indications and conditions as the original product.
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