To understand the growing prominence of biosimilars, one need only look at recent headlines, speakers said during Asembia’s AXS24 Summit, in Las Vegas.

For example, on April 1, CVS Caremark removed Humira (adalimumab, AbbVie) from its major national commercial formularies in favor of covering its biosimilars, said Tasmina Hydery, PharmD, MBA, BCGP, the associate director of digital solutions for Cencora. Dr. Hydery cited these additional developments:

• CVS Health launched Cordavis, a subsidiary to work with manufacturers to commercialize or coproduce biosimilars.
• Mark Cuban Cost Plus Drug Co. joined forces with Coherus to make adalimumab-aqvh (Yusimry), a Humira biosimilar, available at a discounted price of $569.
• The Department of Veterans Affairs replaced Humira on its formulary with adalimumab-bwwd (Hadlima, Organon).

“These large companies are now covering biosimilars either exclusively or allowing preferential prescribing and coverage of biosimilars,” said Cate Lockhart, PharmD, the executive director of the Biologics and Biosimilars Collective Intelligence Consortium. “That’s really important [financially] for our healthcare system.”

There have been nearly 50 FDA approvals of biosimilars and 38 launches across multiple therapeutic areas, including oncology, supportive care, immunology and ophthalmology, Dr. Hydery said. Most reference products have multiple biosimilars, which “really increases the competitive landscape here,” she said.

One area that has seen growth over the past year is immunomodulators, Dr. Hydery said. There’s “no new news” for infliximab biosimilars. As for etanercept-szzs (Erelzi, Sandoz) and etanercept-ykro (Eticovo, Samsung), launches aren’t expected until 2028 and 2029 due to ongoing patent litigations, she said. However, there has been a lot of activity in branded and nonbranded formulations of adalimumab biosimilars, which now number 10. Three were approved with interchangeability. The most recent approval was adalimumab-ryvk (Simlandi, Alvotech/Teva) in February 2024; it is the first that’s both interchangeable and available in high concentrations and citrate-free versions.

Other immunomodulator newcomers include two biosimilars for Actemra (Genentech): tocilizumab-aazg (Tyenne), available as of April 2024, according to its manufacturer, Fresenius Kabi; and tocilizumab-bavi (Tofidence, Biogen), approved in September 2023, which has interchangeability but was not yet available at press time. Also on tap is natalizumab-sztn (Tyruko, Sandoz), approved in August 2023 and expected on the market sometime in the first half of this year, Dr. Hydery said.

Interchangeability a Question

Interchangeability status has long been an area of confusion, Dr. Lockhart said, and is unique to the United States. Last year, the European Medicines Agency stated that any product approved as a biosimilar is automatically assumed to be interchangeable with the reference product and any of its other biosimilars, “which I think is scientifically sound,” she said.

There is legislation before Congress called the Biosimilar Red Tape Elimination Act that would make biosimilars interchangeable with the reference product, Dr. Lockhart noted. However, it doesn’t state that biosimilars would be considered interchangeable with other biosimilars for the same reference product.

The speakers reported no relevant financial disclosures beyond their stated employment.