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Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

Dive Brief:

  • The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland.
  • The partners didn’t announce a launch date or a price for Simlandi, which will be the 10th Humira biosimilar reach market since Amgen’s Amjevita arrived on Jan. 31, 2023. Some biosimilars have launched at a steep upfront discount while others have a list price only slightly below Humira’s to allow for negotiation over rebates.
  • Alvotech also announced a stock sale Monday, raising around $166 million at $16.41 a share. The company had $68 million in cash and equivalents on Sept. 30, after recording losses of $275 million on $30 million in revenue through the first nine months of 2023.

Dive Insight:

One year into the launch of Humira biosimilars, U.S. market share for the copycat drugs is at less than 2%, with Amjevita and Organon’s Hadlima taking the biggest chunk, according to a recent report from biosimilar manufacturer Samsung Bioepis. In providing investor guidance for 2024, AbbVie commercial chief Jeffrey Stewart said the company “once again secured broad formulary access” for Humira.

“While there will be some step down in coverage year over year, we will still have parity access to biosimilars for the vast majority of U.S. patient lives,” he said during a conference call with analysts outlining AbbVie’s fourth quarter 2023 earnings.

While biosimilars haven’t gained much market share, they have affected AbbVie’s revenue. Full year 2023 Humira revenue in the U.S. was $12.2 billion, down by more than one-third over 2022, suggesting intense price competition to remain on insurance coverage lists.

Simlandi won’t be the first interchangeable, or pharmacist substitutable, Humira. That honor went to Boehringer Ingelheim’s Cyltezo, which is a lower-concentration formula. It so far has gained 0.1% market share, according to the Samsung Bioepis report.

Boehringer and Alvotech have aimed for interchangeability status in the hope it will give them a competitive advantage. Forty-seven states allow automatic substitution, although in most the pharmacist must tell the prescribing physician about the substitution, allowing it to be overridden.

Patients stable on branded Humira, along with their physicians, may be reluctant to move to a biosimilar. As a result, uptake of biosimilars for chronic diseases like rheumatoid arthritis has been slower than it has been for oncology, which tends to have shorter treatment courses.