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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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.