FDA approves lower-cost alternative to biotech drug Humira
01:05, Sep 27, 2016
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The Food and Drug Administration has approvedAmgen's Amjevita (adalimumab-atto), a biosimilar of AbbVie's Amgen (adalimumab) and the fourth US biosimilar, the company announced Friday.
Amjevita becomes the fourth biosimilar to be approved in the United States, following Sandoz' Zarxio (filgrastim), Pfizer's Inflectra (infliximab) and Erelzi (etanercept), a second for Sandoz.
According to a report in Medscape News by Troy Brown, "The biosimilar is approved for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis".
The FDA's approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. Its most serious side effects include infection, cancerous conditions and injection-site reactions.
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However, the company may not be able to launch its drug until 2022, because AbbVie is claiming that Amjevita infringes patent protection on Humira that is valid until 2022.
Biosimilars, like Amjevita, are designed as lower cost treatments and similar to generics but are made with living organisms and aren't identical to the complex compounds they replicate. In July, an FDA panel recommended the drug for approval - so marketing approval was seen as a formality.
Amjevita may not hit pharmacies immediately, though. The company did not disclose its plans to launch the drug or the prices it intends to put up in the Friday released issue. The company has sought to stave off Novartis' efforts to steal some of its market share, although the Swiss pharma has already won approval for a biosimilar copy of Amgen's Neupogen and Enbrel.
First approved in 2002, Humira accounted for 60 percent of AbbVie's total revenue a year ago. Humira sales are anticipated to fall in the coming years. Drugs treating breast cancer and colorectal cancer are now in Phase 3 trials.
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