FDA panel unanimously recommends approval of Amgen's Humira biosimilar
- The FDA's Arthritis Advisory Committee on Tuesday voted unanimously to recommend the approval of Amgen's ABP-501, a biosimilar version of AbbVie's Humira (adalimumab), according to an Amgen statement.
- Amgen presented a substantial dossier of data, including analytical data, a pharmacokinetic study, and comparative studies of ABP-501 versus E.U.-approved Humira to ensure no clinically meaningful differences exist when it comes to safety, purity and potency.
- AbbVie plans to defend its patent for Humira in court, contending the blockbuster drug is protected through 2022. Last year, Humira generated $8.4 billion in U.S. sales.
Amgen convinced the FDA panel that ABP-501 was highly similar to Humira, but questions were raised over the drug candidate's efficacy across all of Humira's indications.
ABP-501 was only tested for rheumatoid arthritis and plaque psoriasis, but Amgen is sekking approval for all of Humira's five other indications. To quell these concerns, Amgen argued its proof of similarity to Humira could be extrapolated across indications.
In the end, the FDA committee voted 26-0 to recommend ABP-501 for approval in all indications. The FDA's target action date for ABP-501 is September 25.
The FDA typically follows the advice of its advisory panels, although it is not required to do so.
“We’re pleased with today’s unanimous vote of the FDA’s Arthritis Advisory Committee to recommend approval of ABP-501 in all available indications to the reference product. The Committee’s favorable vote is an exciting step toward recognizing ABP 501 as an important treatment option for patients with inflammatory diseases," said Sean E. Harper executive vice president of Research and Development at Amgen.
Despite yesterday's success, however, the same FDA panel is meeting today to review another rheumatoid arthritis biosimilar–only this time it is a copy of Amgen's Enbrel. Novartis' Sandoz unit hopes to win the panel's support for its drug, which FDA staff reviewed favorably earlier this week.
Sandoz already has one biosimilar, Zarxio, approved for use in the U.S.
Big name pharmaceutical companies have jumped into biosimilar development, eyeing the juicy profits of blockbuster biologics like Humira and Enbrel. But this is muddling the battle lines typically seen in fights over generic copies of pharmaceuticals. Companies like Amgen are arguing for approval of their biosimilar copies of rival biologics one day, only to push back on rivals' biosimilar efforts the next.