Posted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from the company's changes in the manufacturing of the biosimilar during a Phase 3 trial, the company said.
The manufacturing change was due to the “product drift” of the original drug Herceptin.
The company will strongly appeal this to the EMA.
