Ultomiris FDA Approval Gives Soliris Biosimilars Bigger Hurdle
New Rapid Infusion Formulation Bolsters Originator
Alexion Pharmaceuticals’ Soliris (eculizumab) blockbuster represents a significant opportunity for biosimilar sponsors around the globe. Ahead of anticipated US competition in 2025, the originator has added a new formulation for next-generation product Ultomiris (ravulizumab-cwvz).
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Samsung Bioepis responded to Generics Bulletin enquiries following its EU-wide approval for a biosimilar to AstraZeneca’s Soliris.
Samsung Bioepis has seen its SB12 proposed eculizumab biosimilar rival to Soliris endorsed by the EMA’s CHMP. At the same time, three generics also received positive CHMP opinions.
Amgen has received a positive opinion from the EMA’s CHMP recommending that its Bekemv eculizumab biosimilar become the first Soliris rival to be granted a pan-European marketing authorization.