Shots: Followed by HC’s approval in Aug 2022, Lupin with its partner Sandoz launched Rymti (biosimilar, Enbrel) in Canada The study showed that Rymti has equivalent safety and efficacy to Enbrel. It is a solution for injection in the form of a pre-filled pen & pre-filled syringe Rymti is intended to treat children and…
Shots: The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19 The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU…

