FDA Approves First Biosimilar Drug

The first of a new class of drugs, called biosimilars, has been approved for use in the US by the Food and Drug Administration. Zarxio is a drug used to treat cancer patients by boosting their white blood cell production. The drug is similar to a drug called Neuropogen. The FDA decision comes after an expert panel unanimously recommended the drugs approval.

“Biosimilars will provide access to important therapies for patients who need them,” Dr. Margaret A. Hamburg, the commissioner of the F.D.A., said in a statement.

The FDA’s decision when it comes to Zarxio is significant as it may open the door for more of these cheaper medications to approved for use in the US. Brand name biologic drugs, medications made of living cells as opposed to synthesized from chemicals, have so far been immune to cheaper generic versions, but this approval may change that.

“This is the first approval for low cost alternatives to biological drugs. It will reasonably allow for reduction of cost in older cancer care drugs, clearing room in the budgets for new breakthrough cancer agents,” Ronny Gal, a senior research analyst Sanford C. Bernstein & Company, said in an email to the New York Times.

Biologic drugs were previously thought to be too complex to replicate in a generic form but advances in technology have made it possible. The approval of biosimilars, generic biologics, could save the US $250 billion in drug costs over then next decade if 11 biosimilars currently in production are approved for sale.


Read More – F.D.A. Approves Zarxio, First Biosimilar Drug (New York Times, Sabrina Tavernise)

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Originally from Gaithersburg, Maryland, Millan is a senior at the George Washington University studying Biological Anthropology.


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