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Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More
Two FDA advisory committees recommend the approval of Egalet's opioid Arymo to manage severe pain that requires daily, long-term treatment when alternatives are unavailable, with three abuse-deterrent labels. Read More
Sandoz’s application to produce a biosimilar of Amgen’s bone marrow drug Neulasta has been rebuffed by the agency, according to Sandoz’s parent company, Novartis. Read More
In a blow to the biosimilars industry, the federal appellate court has reiterated its position that biosimilars makers must give reference product holders six months’ notice before going to market. Read More
A Delaware federal court ruled that Mylan’s efforts to develop a generic version of Forest Laboratories’ Savella infringed on three of the company’s patents. Read More
An FDA advisory committee recommended FDA approve Amgen’s biosimilar of the AbbVie’s blockbuster drug Humira and Sandoz’s biosimilar of Amgen’s Enbrel. Read More