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FDA accepts biologics license application for proposed biosimilar to Neulasta
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The FDA accepted Mylan’s biologics license application for MYL-1401H — a proposed biosimilar to pegfilgrastim — for filing through the 351(k) pathway.
MYL-1401H — developed under a partnership between Mylan and Biocon — is intended to reduce the duration of neutropenia and the incidence of fever that is associated with neutropenia in adults treated with chemotherapy for certain types of cancer.
This acceptance of an application for review is the second for the partnership within the past 2 months, Rajiv Malik, president of Mylan noted in a press release.
“The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim (Neulasta, Amgen) in Europe, Australia and Canada and reinforces our dedication and commitment to establishing a global platform for this product,” he added. “Once approved, proposed biosimilar pegfilgrastim will complement Mylan's broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer.”
The FDA goal date is set for Oct. 9, 2017, the release said.
“We are extremely pleased with the regulatory progress of our biosimilars in the United States,” Arun Chandavarkar, PhD, CEO and joint managing director of Biocon, said in a press release.
“...Once approved, our proposed biosimilar pegfilgrastim will provide a high-quality alternative to branded pegfilgrastim for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer care affordable and accessible for patients across the globe.”