The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar ...

More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry ...

Biosimilars offer affordable medical treatments, but regulatory guidelines need updating to ensure safety, efficacy, and ...

Co-production deals with adalimumab biosimilar manufacturers and PBMs have increased biosimilar adoption, but this ...

Rising biosimilar adoption, shifting market dynamics, and escalating supply chain vulnerabilities are driving change in ...

India needs to update its biosimilar regulations to ensure safe, effective, and affordable medicines, balancing quality and cost for better patient care.

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

Originally approved by the FDA in September 2023, Biogen's Tofidence became the first tocilizumab biosimilar available in the ...

Henlius and Organon announced the European Medicines Agency validates filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 ...

Trump cutbacks were supposedly aimed at administrators. But scientists in food and drug-testing labs and policy experts who advance generic drug approvals were also dismissed.

The US has exempted Indian pharmaceuticals from tariffs amidst President Trump’s broad tariff imposition, recognizing their ...