The latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use has resulted in positive opinions for Accord Healthcare’s Stelara (ustekinumab) biosimilar as well as a buprenorphine hybrid film for Neuraxpharm and an eltrombopag generic for Viatris.
While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert them...