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.

In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to enable broad genus claims, both Sanofi SA and Amgen Inc. are warning that future innovation will be at stake if the court accepts the other company’s position.

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.

Taking aim at big pharma’s current penchant for acquisition over in-house innovation, Sen. Elizabeth Warren (D-Mass.) is asking the Federal Trade Commission (FTC) to consider the impact a biopharma merger, whether it’s proposed or a done deal, may have on future innovation.

New research published in BMJ Open claims there are inconsistencies in Amgen Inc.’s phase III Fourier study for cholesterol lowering. Cardiac deaths were numerically higher in those taking the PCSK9 inhibitor Repatha (evolocumab) combined with a statin than those in the placebo group, the research noted.

South Korea’s Legochem Bioscience Inc. inked a licensing deal with Amgen Inc. on Dec. 23 for five undisclosed antibody drug conjugate (ADC) targets worth up to ₩1.6 trillion (US$1.24 billion). Under the terms of the deal, Legochem will out-license global rights to Amgen for five undisclosed ADC targets and will receive an undisclosed up-front payment as well as development milestones and sales royalties. The companies did not disclose additional details.