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.”
Mymd Pharmaceuticals Inc., the privately held developer of a synthetic derivative of tobacco alkaloids for the potential treatment of autoimmune diseases and age-related disorders, will soon list on Nasdaq via its acquisition of former point-of-care testing company Akers Biosciences Inc., shares of which (NASDAQ:AKER) climbed 29.1% to $2.22 on Nov. 12. The combined company, to be headquartered in Baltimore, will retain Mymd's name and adopt the trading symbol MYMD. Concurrent with the merger, Akers is raising $18 million in a private placement priced at-the-market.