Biosimilar Development News
-
Positive Top-Line Efficacy And Safety Data From Global Phase III Clinical Trial Of Tanvex Trastuzumab Biosimilar Candidate, TX05
2/20/2021
Tanvex BioPharma, Inc. today announced results from a Phase III study evaluating efficacy and safety of its trastuzumab biosimilar candidate, TX05, compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer.
-
Somru BioScience And Veeda Clinical Research Announce Joint Venture Global Biotherapeutic Contract Research Organization (CRO) In India
2/18/2021
Ingenuity BioSciences Pvt. Ltd – Veeda Clinical Research, one of India’s leading and largest independent CRO companies, and Somru BioScience Inc., a leading Canadian-based biotechnology company based in Charlottetown, Prince Edward Island, are proud to announce the establishment of an innovation-centric bioanalytical laboratory in Ahmedabad, India.
-
Fresenius Kabi Canada launches IDACIO® (adalimumab injection), A Biosimilar To HUMIRA® (adalimumab) For The Treatment Of Multiple Chronic Inflammatory Diseases
2/18/2021
Fresenius Kabi Canada, a healthcare company specializing in drugs and infusion, transfusion and clinical nutrition technologies, today announced the launch of IDACIO ® , an adalimumab biosimilar, in Canada.
-
Coherus BLA Filing For Adalimumab Biosimilar Candidate Accepted By FDA For Review
2/17/2021
Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) has accepted for review the 351(k) Biologics License Application (“BLA”) for CHS-1420, a Humira® (adalimumab) biosimilar product candidate, and has set a Biosimilar User Fee Act action date for December 2021.
-
Paras Biopharmaceuticals Finland Oy Affordable Healthcare Efforts Viewed In Over 90 Countries: Biosimilar Technologies Get Attention
2/16/2021
Paras Biopharmaceuticals Finland Oy (Paras Biopharma) is a Finland-based microbial biologics company which focuses on the development of technologies for biosimilars and biologics in an efficient manner.
-
Biocon Biologics Joins Hands With IDF In Its Mission To Promote Diabetes Care, Prevention And Effective Management Worldwide
2/16/2021
Biocon Biologics Ltd., a fully integrated ‘pure play’ biosimilars company and a subsidiary of Biocon Ltd., is pleased to partner with The International Diabetes Federation (IDF) as the first biosimilar insulins company to promote and support IDF’s Core Mission initiative and activities.
-
Sandoz Canada Completes Its 5th Biosimilar Launch With New Biosimilar Hyrimoz® (adalimumab)
2/16/2021
Sandoz Canada Inc. announced today the launch of Hyrimoz® (adalimumab injection, reference biologic drug: Humira®), which was authorized for sale in Canada by Health Canada on November 4, 2020 as one of the four Sandoz biosimilars to be authorized in Canada in the last 11 months.
-
Celltrion Healthcare Receives European Commission (EC) Approval For The First High Concentration, Low-Volume And Citrate-Free Biosimilar Adalimumab, Yuflyma (CT-P17)
2/15/2021
Celltrion Healthcare today announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases.
-
Fujifilm Kyowa Kirin Biologics And Mylan EPD Announce Launch Of ‘Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]’ In Japan
2/15/2021
Fujifilm Kyowa Kirin Biologics Co., Ltd. and Mylan EPD G.K., a company of the Viatris group, today announced that “Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]”, a biosimilar to AbbVie's Humira (Adalimumab (Genetical Recombination)), the top-selling drug in the world*, has launched in Japan. This is the first launch of a biosimilar to Humira in Japan. Mylan EPD G.K. is in charge of the commercialization.
-
North America Accounts For Almost Half Of The Global Rituximab Biosimilars Market, Europe Follows With Second-Largest Share
2/11/2021
According to The Business Research Company’s research report on the rituximab biosimilars market, North America was the largest region in the rituximab biosimilar market, accounting for 48% of the total in 2020. It was followed by Western Europe and Eastern Europe, and then the other regions.