The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.
The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.
Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns
March 21st 2023At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?
Biorationality: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars Role Within Big Pharma
March 13th 2023Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.
Biosimilars Regulatory Roundup for November 2022—Podcast Edition
December 4th 2022On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.
FDA Approves Autoinjector Version of Neulasta Biosimilar
March 6th 2023The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.
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