Tag Archives: biosimilar

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 »

Novartis abandons effort for U.S. approval of biosimilar rituximab

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo (Reuters) – Novartis International AG said on Friday that its Sandoz division is abandoning an effort to gain U.S. regulatory approval for a biosimilar of rituximab, a medication used… Read More »