FDA approves first biosimilar treatment

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The Food and Drug Administration approved its first biosimilar product in March, opening the door for more costly drug alternatives.

The first medication, Sandoz's Zarxio, is similar to Amgen Inc.'s Neupogen, which is used for cancer patients. Other examples of well-known biologic drugs are Remicade for treatment of rheumatoid arthritis or Herceptin and Avastin for cancer treatment. 

The decision was put in motion by the Affordable Care Act, which included in the law Biologics Price Competition to reduce the cost of biologics to patients. Biologics are made from living cells, blood or tissue, compared to chemical medications. 

“Patients and the healthcare community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards,” said FDA Commissioner Margaret A. Hamburg, M.D.

A biosimilar product can be approved only by the FDA if it has the same form of action, route of administration, dosage and strength as the original medication, and can only be used for the specific conditions, the agency said.

While Zarxio may not be used in long-term care as much as acute care, as more biosimilar products become available, providers will write the proprietary name or nonproprietary name on the prescription. Interchangeable products can be substituted at the pharmacy. Still, the biosimilar development process can take a manufacturer a decade, with millions of dollars invested. Amgen is working on nine biosimilars based on competitors' drugs, with the first expected to hit the market in 2017, and four more by 2019, according to industry reports


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