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…
