FDA Approves First Biosimilar Medication To Be Sold in U.S.
On Friday, FDA approved Zarxio, Novartis AG's version of Amgen's biologic drug Neupogen, making it the first biosimilar medication approved by the agency, the Wall Street Journal reports (Rockoff/Loftus, Wall Street Journal, 3/6).
According to the Washington Post's "Wonkblog," Novartis is already selling the biosimilar in more than 40 countries (Millman, "Wonkblog," Washington Post, 3/6).
Biologics are developed from living cells, which makes the drugs both costly to develop and impossible for generic drugmakers to manufacture exact replicas. However, generic drugmakers can develop less-costly versions of the drugs, called biosimilars, that are close enough to biologics to function in the same manner.
Neupogen is used to lower the rate of infections in cancer patients undergoing chemotherapy. In July 2014, FDA accepted an application from Sandoz -- a subsidiary of Novartis -- seeking approval for its biosimilar of Neupogen, marking the first time the agency agreed to consider approval for a biosimilar (California Healthline, 7/25/14).
An FDA advisory panel in January voted 14-0 to recommend the agency approve Zarxio (California Healthline, 1/8).
FDA approved Zarxio for all the same uses as Neupogen, and the agency said the drug could use nearly identical language on its label as the brand-name version, the New York Times reports (Tavernise/Pollack, New York Times, 3/6).
Overall, FDA said Zarxio and Neupogen have "no clinically meaningful differences" ("Wonkblog," Washington Post, 3/6).
FDA named the drug filgrastim-sndz, which includes the generic name for the Neupogen and a suffix that stands for Sandoz, the manufacturer. According to the Times, the decision is significant because some generic drugmakers and insurers want the biosimilars to carry the same generic name as the brand-name product, while some biologic manufacturers argue that the name should be different to facilitate tracing a drug's side-effects to the drugmaker.
John Jenkins, director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, said the naming of the biosimilar did not establish a FDA policy on naming such drugs (New York Times, 3/6).
FDA said it soon would release official guidance on naming biosimilars, as well as on interchangeability. According to "Wonkblog," such guidance could affect the uptake of biosimilars, since pharmacies could automatically substitute a product deemed interchangeable for the brand name biologic ("Wonkblog," Washington Post, 3/6).
Market Launch Delayed
Despite FDA approval, it could be weeks until the treatment is available in the U.S., the Journal reports.
According to the Journal, Amgen has asked a federal judge to issue an injunction to stop the sale of Zarxio, alleging that Novartis did not follow regulations for seeking FDA approval. A hearing in the case is scheduled for March 13. Novartis has said it would hold the drug's launch until a decision has been issued or until April 10, whichever comes first (Wall Street Journal, 3/6).
Approval Could Pave the Way for More Biosimilars
According to The Hill, Zarxio's approval could pave the way for the approval of other biosimilars, which could increase competition and lower costs in the country's prescription drug market (Sullivan, The Hill, 3/6).
According to Avalere Health, less-costly biosimilar drugs are predicted to save the U.S. about $47 billion over the next decade. Currently, the U.S. spends about $82 billion per year on biotech drugs, accounting for 22% of its annual spending on drugs.
However, it is not yet clear how much other biosimilar treatments could cost, and Zarxio's cost will not be announced until the drug is put on the market. Novartis so far only has indicated that the drug will be "competitively priced." By contrast, one dose Neupogen can cost between $315 and $500.
Overall, biosimilars available in Europe generally cost between 15% and 30% less than their brand-name counterparts, according to the Journal (Wall Street Journal, 3/6). According to "Wonkblog," such reduced prices could save patients thousands of dollars for drugs that treat complex diseases, such as cancer or rheumatoid arthritis ("Wonkblog," Washington Post, 3/6).
Meanwhile, it is still unknown whether U.S. providers will embrace biosimilars. Gary Lyman, an oncologist at the Fred Hutchinson Cancer Research Center, said, "I don't think it's going to be an overnight sensation. I think oncologists are going to have to gain from experience that (biosimilars) are safe, they're efficacious, and patient convenience and quality of life is maintained" (Wall Street Journal, 3/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.