Tag Archives: biosimilar

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Home News New Drugs FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin Print this page January 18, 2019 — FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »

FDA approves first biosimilar to Roche cancer drug Rituxan

(Reuters) – Celltrion Inc’s Truxima on Wednesday became the first biosimilar to Roche Holding AG’s $ 7-billion-per-year cancer drug Rituxan to be approved in the United States to treat non-Hodgkin’s lymphoma. FILE PHOTO: The logo of Celltrion is seen at company’s headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji The approval by the… Read More »

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta Print this page REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients… Read More »