Biogen says it is the first drugmaker in the US to get FDA approval for a biosimilar of Roche’s $3 billion blockbuster product Actemra. The intravenous biosimilar of IL-6 inhibitor Actemra ...

Bio-Thera Solutions, the developer of the biosimilar, will continue to hold manufacturing rights in the US market.

Roche's Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi's rival therapy Kevzara has also been hit by supply constraints.

Organon (NYSE:OGN) announced Tuesday the acquisition of regulatory and commercial rights linked to Tofidence, a biosimilar developed by Biogen (NASDAQ:BIIB) as an intravenous therapy targeting Roche’s ...

Biosimilar challenges include complex manufacturing processes and regulatory obstacles, offset by less regulated market ...

Organon has announced the acquisition of the US regulatory and commercial rights for intravenous infusion of the Actemra biosimilar, Tofidence, from Biogen. The move is set to bolster and widen ...

arthritis drug Actemra. Biogen (NASDAQ:BIIB), which obtained regulatory and commercial rights to Tofidence from the Chinese biotech Bio-Thera Solutions in 2021, launched the monoclonal antibody ...