As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its…
As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its…
On Monday, Hikma announced a partnership with Celltrion to market YUFLYMA (CT-P17) in the Middle East and North Africa. CT-P17 is a high-concentration, low-volume and citrate-free adalimumab…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products. On June 23, 2022, CHMP…
Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on…
Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023. The announcement stems from Celltrion’s recently inked patent agreement with…
A recently-published study reported that Celltrion’s CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with reference drug HERCEPTIN when used to treat patients…
On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are…
On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent…
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to…
According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product. YUFLYMA was previously approved in Europe, and is a…