Biologics Overshadow Small Molecules In US FDA’s 2023 Novel Approvals

Gene therapies, bispecific antibodies and vaccines stand out among 2023’s 34 novel biologics and the US FDA’s 38 new molecular entities include fewer breakthroughs.

teamwork
Biologics dominated the products entering the FDA's expedited approval programs in 2023. • Source: Shutterstock

Biologic medicines drove innovation in 2023, contributing an outsize share of products qualifying for the US FDA’s expedited review programs compared with new molecular entities.

More from Approvals

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.

New EU Filings

 

Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Japan Recommends Beyonttra, Raises Enhertu Price

 
• By 

Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.

More from Product Reviews