News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices.
Although broader use of biosimilars in the U.S. would reduce Medicare Part D spending and save beneficiaries nearly $2 million in out-of-pocket costs, plan formularies continue to discourage the use of the more affordable follow-ons, according to a recent report from the Department of Health and Human Services’ Office of Inspector General.
Results from a phase III study comparing Celltrion Inc.’s biosimilar VEGF ligand inhibitor CT-P16 to Roche Holding AG’s Avastin (bevacizumab) in patients with metastatic or recurrent non-squamous non-small-cell lung cancer (NSCLC) found it to be similarly effective and as safe compared to the reference drug. Incheon, South Korea-based Celltrion presented the results at the 2022 annual meeting of the American Association for Cancer Research. The company now plans “to speed up the approval process through consultation with regulatory authorities in each country,” a Celltrion official said.
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
Biocon Ltd. said its subsidiary Biocon Biologics Ltd. has agreed to buy out partner Viatris Inc., bringing aboard the latter’s biosimilars business, for $3.34 billion.
Shanghai Henlius Biotech Inc. has licensed its adalimumab biosimilar Handayuan to Getz Pharma Pvt. Ltd. and its affiliated company Getz Pharma International FZ LLC in an $8 million deal.
Biocon Ltd. said its subsidiary Biocon Biologics Ltd. has agreed to buy out partner Viatris Inc., bringing aboard the latter’s biosimilars business, for $3.34 billion, including cash of $2.34 billion and compulsorily convertible preference shares (CCPS) in BBL, valued at $1 billion.
Shanghai Henlius Biotech Inc. has licensed its adalimumab biosimilar Handayuan to Getz Pharma Pvt. Ltd. and its affiliated company Getz Pharma International FZ LLC in an $8 million deal.
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
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