It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.

Modest signs of recovery were seen in the biopharma IPO market in 2024, though activity remains significantly below the levels seen during the 2018-2021 boom. In 2024, 32 biopharma companies went public, a slight increase from 27 in 2023 but a decline from 35 in 2022. These figures pale in comparison to the peak years, with 134 IPOs in 2021, 106 in 2020 and even 65 in 2019. Both the total value and volume of IPOs continue to lag far behind those earlier highs.

The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future.

Biopharma companies secured $102.15 billion in funding in 2024, a 44% increase from $70.97 billion in the full-year 2023 and significantly higher than the $60.81 billion raised in 2022. December financings reached $4.69 billion, marking an increase from $3.6 billion in November.

Publication on Dec. 12, 2024, of data analysis regarding Merck & Co. Inc.’s Winrevair (sotatercept) in Clinical Pharmacology & Therapeutics may have put investors in mind of the odds for the activin signaling inhibitor beyond pulmonary arterial hypertension, the indication for which Winrevair was approved by the U.S. FDA in March of last year.

The top 10 med-tech stock gainers and losers for the week.