Regeneron has had its hands full this year contending with regulatory setbacks, Amgen's marketed Eylea biosimilar and Roche's hard-charging ophthalmology rival Vabysmo. Next year, the biosimilar ...

The FDA is revising biosimilar approval processes, eliminating "switching" and comparative efficacy studies, favoring analytical assessments. These changes could reduce development costs by 80%, ...

Tyruko, the first natalizumab biosimilar for multiple sclerosis, promises significant savings and competition in the US market. The launch of natalizumab-sztn (Tyruko) marked a milestone for ...

The proposed aflibercept biosimilar is intended to treat ophthalmic disorders. This FDA submission follows the licensing agreement under which Fresenius Kabi will exclusively commercialize the ...