Another Humira biosimilar approved by FDA as AbbVie patent expiry looms

2022-12-15

上市批准专利到期专利侵权生物类似药

Dive Brief:

Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.

The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company won’t launch Idacio in the U.S. until July.

Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.

Dive Insight:

The end of AbbVie’s monopoly promises to be a major event for the pharmaceutical industry. Humira brought in almost $21 billion in sales last year, including more than $17 billion in the U.S. For years, AbbVie has carefully built a wall of patent protections around the drug, extending its market exclusivity well beyond the main U.S. patent’s expiration in 2016.

Amgen will be the first company to challenge AbbVie when it introduces its Amjevita biosimilar next month. A raft of other copycat versions — now including Idacio — will enter the market in July.

While the biosimilars will likely cost less than Humira, the question is how far the challenger companies will go in cutting a list price that for the branded drug now reaches almost $80,000 a year. Drug rebating is also likely to factor into companies’ competitive calculus as they seek to challenge AbbVie.

So far, the biosimilar market has failed to deliver on the promise of massive cost savings, but no drug has faced the volume of competition that will confront Humira starting in July.

The FDA has cleared 40 biosimilar products to date, including eight that will take on Humira. Another copycat Humira product from Alvotech may win clearance this month, although it hit a setback earlier this year due to deficiencies in the company’s manufacturing plant. Alvotech intends to launch its version in July, if approved.

FDA-approved Humira biosimilarsDrug nameApproval dateExpected launch dateCompanyAmjevitaSeptember 2016Jan. 31, 2023AmgenCyltezo August 2017 (first approval)July 1, 2023Boehringer IngelheimHyrimozOctober 2018Sept. 30, 2023NovartisHadlimaJuly 2019June 30, 2023Samsung Bioepis, OrganonAbriladaNovember 2019“As early as” July 2023PfizerHulioJuly 2020July 31, 2023ViatrisYusimryDecember 2021July 1, 2023Coherus BioSciencesIdacioDecember 2022July 1, 2023Fresenius KabiSource: FDA

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