A slew of biosimilar versions of TNF-alpha inhibitor adalimumab will finally arrive on the U.S. market in 2023, almost seven years after the first such molecule, Amgen Inc.’s Amjevita (adalimumab-atto) gained U.S. FDA approval. Amgen commercially launched its product on Jan. 31. Seven more are lined up for launch over the summer, while two more are undergoing regulatory review. Their long-anticipated arrival will mark the beginning of the end for one of the most lucrative franchises in the history of the pharmaceutical industry. It represents, according to Cardinal Health Inc.’s newly published 2023 Biosimilars Report, “the largest loss of exclusivity event, perhaps ever in the U.S.”
If the Feb. 16 hearing before the U.S. Senate Commerce Committee is anything to go by, it’s almost a given that the bipartisan Pharmacy Benefit Manager (PBM) Transparency Act will eventually be passed by the Senate. But its journey through the Republican-controlled House could be more uncertain in light of growing concerns about an “activist agenda” at the FTC.
A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started Jan. 31 with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition will come in five months when other adalimumab biosimilars, including Boehringer Ingelheim GmbH’s interchangeable, hit the market.
With at least six others behind it, Amgen Inc.’s Amjevita is leading a 2023 U.S. biosimilars charge to challenge the all-time biggest-selling drug, Humira (adalimumab), from Abbvie Inc. Amjevita hit the U.S. market Jan. 31, and Amgen has the biosimilar priced at two levels, both lower than Humira’s. One is a list price 55% below Humira’s list price of about $115,000 annually and the second is 5% below Humira’s list price. Boehringer Ingelheim GmbH, Sandoz Inc., Samsung Bioepis Co. Ltd./Organon & Co., Pfizer Inc., Viatris Inc. and Coherus Biosciences Inc. all have biosimilar challengers to Humira that are set to launch in July 2023, all likely to come with a lower price tag than Humira’s.
Many industry watchers are looking to 2023’s Humira biosimilar launch in the U.S. as a portent of the future of biosimilars. While it should help raise awareness of biosimilars in general and produce savings in the immunology sector, its distinctness could make it an outlier in the world of current and future biosimilar competition.
Even though the EU had approved more than a dozen biosimilars by 2012, the follow-on biologics were still in their embryonic stage around the world when BioWorld published The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies in early 2013. Now, nearly a decade later, the global biosimilar landscape has matured with many more biosimilars approved across the globe, but the uptake, and thus the savings, is not what some policy makers and people in industry had hoped for or expected.
Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.
Although it’s a make-or-break market for many novel drugs, the U.S. is still testing the waters with biosimilars to some extent. That’s expected to change when at least seven biosimilars, including an interchangeable, referencing Abbvie Inc.’s Humira (adalimumab) are set to launch in the U.S. within the first seven months of next year. Next week, BioWorld will look at the significance of that looming competition and how the global biosimilars market is evolving amid a changing landscape of players, policies and pipelines.
Within a few weeks, government price negotiations for some prescription drugs, as well as limits on annual price increases, could be the law of the land in the U.S. With the Senate passing a slimmed-down version of H.R. 5376 through reconciliation Aug. 7, the House is expected to make a brief return Friday from its August recess to vote on the changes and conference the differences between its bill and the Senate version. Then it’s on to the president’s desk for the signature that will enact the package of health care, tax and climate provisions.
How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars.
