Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications
Accord Already Holds Final Approval For Lenalidomide Generic
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.
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Mylan’s proposed $12bn combination with Pfizer’s Upjohn unit is expected to close next month following a settlement agreement with the FTC, with a requirement to address competition concerns in ten markets. The FTC was however strongly divided on the deal, with dissenters labelling the directives of the Commission as “deeply flawed, favoring routine over rigor.”
Almost 500 days after the transaction was first announced, Viatris, the proposed combination of Mylan and Pfizer’s Upjohn, is set to receive word from the US Federal Trade Commission, representing the last major obstacle to getting the deal over the line.
Amgen’s management took a deep dive into biosimilar market dynamics during the company’s third-quarter earnings call, as the California-based biotech continued to enjoy success for biosimilars in the US and Europe.