Celltrion files for FDA approval for Remicade biosimilar

South Korean biopharmaceutical company Celltrion has applied for approval from the US Food and Drug Administration (FDA) to market a biosimilar version of Remicade (infliximab), it announced yesterday (August 11).

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk

More on this story

Americas

Hikma triumphs at SCOTUS in landmark skinny-label ruling

4 June 2026 Justices refuse to place generic drug makers “between a rock and a hard place,” in a landmark ruling clarifying induced patent infringement in pharma.

Americas

Heated LNP litigation puts Moderna and Acuitas in the spotlight

3 June 2026 A district court has thrown out one challenge over the vaccine delivery technology, while a separate appeal could affect protections available to government contractors during national emergencies.

Americas

J&J unit's valuable heart pump saved by 'rare' patent defence

1 June 2026 A district jury has handed a J&J unit a clean sweep in its defence against a rival's heart pump patent claims, delivering a win under the seldom-invoked reverse doctrine of equivalents.

More features

Hikma triumphs at SCOTUS in landmark skinny-label ruling

Pfizer strikes $10.5 billion oncology deal with Chinese biotech

Dehns appoints head of litigation following wave of senior hires

Chadha & Chadha hires former Remfry & Sagar patent partner

Heated LNP litigation puts Moderna and Acuitas in the spotlight

UPC dispute resolution forum opens with ceremony in Slovenia

J&J unit's valuable heart pump saved by 'rare' patent defence

Kirkland & Ellis adds leading barrister in London

Celltrion files for FDA approval for Remicade biosimilar

More on this story

Editor's picks

Editor's picks

More features