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Eylea biosimilar by Samsung Bioepis, now FDA-approved, will stay on hold

By Melissa Ritti ( January 29, 2025, 19:13 GMT | Insight) -- The US Court of Appeals for the Federal Circuit today refused to undo a preliminary injunction barring South Korea-based Samsung Bioepis, or SB, from launching in the US a biosimilar to Regeneron Pharmaceuticals’ biologic Eylea. The abbreviated Biologics License Application, or aBLA, and notice of commercial marketing by SB, combined with the established nationwide distribution channels of SB’s US-based distributor Biogen MA, is enough to confer personal jurisdiction here, the court ruled in a precedential ruling with major implications for biosimilar makers abroad. A preliminary injunction entered in multidistrict litigation which barred the commercial launch of a planned biosimilar to the prescription macular degeneration drug “Eylea” won’t be disturbed....

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