Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Accord Already Holds Final Approval For Lenalidomide Generic

16 Oct 2020

Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.

3d render of Europe map Earth globe — Mylan's generic lenalidomide product was backed by the CHMP • Source: Shutterstock

Mylan has been backed by the European Medicines Agency’s Committee for Medicinal Products for Human Use to receive a pan-European marketing authorization for the US firm’s generic to Celgene’s Revlimid (lenalidomide) capsules to treat multiple myeloma and follicular lymphoma.

Announcing its recommendation for Lenalidomide Mylan, the CHMP said studies demonstrated “the satisfactory quality of Lenalidomide Mylan and its bioequivalence...