In July, Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd.) became the first amyloid-targeting drug to win traditional approval from the U.S. FDA, after getting accelerated approval in January based on the surrogate endpoint of plaque removal.

The long, strange and nowhere-near-concluded trip taken by psychedelic drugs as a therapeutic modality continued in 2023, with regulators in the U.S. and Europe – and, perhaps in greater numbers, investors – warming to prospects in a space that once drew only laughter.

As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field.

As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field.

Vesalius Biocapital Partners Sàrl has called a first close on its fourth fund at €95 million (US$103 million) and now is targeting a total of €150 million, with new investors to be accepted on a "rolling closing" basis until the final close in 2024.

Sarepta Therapeutics Inc. has set the wholesale acquisition cost of the first gene transfer therapy for ambulatory patients with Duchenne muscular dystrophy at $3.2 million, making it one of the most expensive gene therapies. The company said the gross-to-net price for Elevidys (delandistrogene moxeparvovec) will be in the mid-20% range, which, suggests Mizuho Group analyst Uy Ear, would put the price at about $2.4 million.

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.

Now in its 10th year, Clarivate’s newly released Drugs to Watch 2023 report primarily features treatments targeted to a particular biomarker, signaling the advance and increasing potential of personalized medicines. The 15 drugs on the list are anticipated to either register sales of more than $1 billion by 2027 or be clinical game changers. Nine are predicted to hit $1 billion annual sales each in China by 2030.