The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.

The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.

If the bill on the Biosimilar Red Tape Elimination Act is passed, all biosimilars would be deemed interchangeable on US FDA approval. Scrip takes a look at what empowering pharmacists could mean, what the generics substitution experience shows and where possible pain points lie

Sun stays “tentative” about a large exposure in the biosimilars segment while also outlining its approach to commercialize some diverse pipeline assets including an early stage GLP-1 receptor agonist.