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biosimilar

Coherus Neulasta Biosimilar Autoinjector Gets FDA Approval

March 9th, 2023|Categories: Featured, Industry News|Tags: , |

The US Food and Drug Administration has approved the use of an autoinjector version ofUdenyca Coherus Biosciences biosimilar to Amgen’s Neulasta, a drug that reduces the chance of developing febrile neutropenia after chemotherapy. While this is the first approved autoinjector version of the drug, it’s far from the only biosimilar.

Polpharma Files for EU Approval of Tysabri Biosimilar

July 18th, 2022|Categories: Featured, Industry News|Tags: , , , |

Polpharma Biologics has filed for approval in the EU for its biosimilar of Tysabri, Biogen’s multiple sclerosis (MS) therapy. The application is the first of its kind in the EU, and covers the intravenous version of the drug. Biogen originally had 5 more years of exclusivity, but a key patent for the drug was revoked in a European court last year.

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