Trump administration officials pledged Monday that major reforms for biosimilar drug approvals will expand access and lower ...

The FDA has revealed a set of measures designed to increase the availability of biosimilars in the U.S. and in turn reduce ...

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, ...

With its biosimilars business thriving, Amgen isn’t a fan of changes proposed by HHS Secretary Robert F. Kennedy Jr. | With its biosimilars business thriving, Amgen isn’t a fan of changes proposed by ...

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...

Mark Cuban Cost Plus adds Stelara biosimilar Starjemza, offering it at $360 per syringe to lower biologic drug costs for patients.

Food and Drug Administration is preparing to speed up approvals for biosimilars, or generic versions of complex biological ...

The new approvals bring the number of denosumab biosimilars in the US to eight, but price reductions are not yet substantial.

Alvotech, with its strategic commercialisation partner Advanz Pharma, received EMA approval for Mynzepli (AVT06) in August ...

The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...