January 28, 2023
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FDA panel recommends Amgen biosimilar drug for approval


A Food and Drug Administration panel recommended an Amgen biosimilar drug for approval July 12, just days after it said the biosimilar performed like a drug it mimicked.

ABP 501, made by Thousand Oaks biotech giant Amgen, replicates the effects of Humira, which is approved to treat nine conditions including rheumatoid arthritis, skin disorders and colon inflammation. In documents posted on the agency’s website July 8, the FDA said ABP 501 effectively replicates Humira’s treatment of rheumatoid arthritis and the other conditions it treats.

Humira, made by Chicago-based competitor AbbVie, typically costs $20,000 per year for treatments. Sales of the drug were $14 billion last year.

Biosimilars, like ABP 501, 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. Because the compounds are not identical, extensive testing must still take place to ensure their safety, which does not lower the cost of the drugs as much as generics.

During the meeting, some members of the FDA’s Arthritis Advisory Committee expressed some concern about data presented by Amgen about ABP 501’s safety. Ultimately, though, the panel decided the science was sound and voted to recommend approval of the drug.

The drug is still not yet approved for marketing and needs to be formally approved by the FDA. The agency almost always follows the recommendations of its panels.

The FDA said it will decide whether to approve ABP 501 by Sept. 25.

If the drug is approved, Amgen plans to launch ABP 501 by 2018. AbbVie contends it holds uninfringeable patents on the drug until 2022, but a key patent expires later this year.

Amgen will fight the biosimilar battle on a different front July 13 when the same FDA committee considers whether to recommend GP2015 for approval. GP2015, made by Switzerland-based Novartis AG, replicates the effects of Amgen’s blockbuster drug Enbrel.

Enbrel had global sales of $5.6 billion last year and treats rheumatoid arthritis and psoriasis. The drug works by decreasing the amount of a protein produced by the immune system.

This story was updated to say Humira sales were $14 billion in 2015, not $6 billion.

• Contact Philip Joens at pjoens@pacbiztimes.com.