Biosimilar Development News

31. Celltrion USA Announces Submission Of The Biologics License Application (BLA) Of Novel Subcutaneous Formulation Of CT-P13 To U.S. Food And Drug Administration 12/22/2022

    Celltrion USA today announced the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA) for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the U.S. Food and Drug Administration (FDA).

32. Update On U.S. Regulatory Status Of AVT02, Alvotech’s Proposed High-Concentration, Interchangeable Biosimilar To Humira® 12/22/2022

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the FDA has granted a new Biosimilar User Fee Amendment (BsUFA) goal date of April 13, 2023, for Alvotech’s original Biologics License Application (BLA) for AVT02 as biosimilar to Humira®.

33. Sandoz Canada Supports Ontario Policy Change To Cover Biosimilars Which Will Generate Significant Cost Savings And Improve Patient Access To Quality Medicines 12/22/2022

    Sandoz Canada, a global leader in generic pharmaceuticals and biosimilars, welcomes the Ontario Government introduction of biosimilars switch policy to expand the use of biosimilars available on the market and generate significant cost savings to the province healthcare system.

34. Mabwell Bioscience Partners With Binnopharm Group To Market 9MW0113, 9MW0321 And 9MW0311 In Russia And Eurasian Economic Union Countries 12/20/2022

    Mabwell Bioscience (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, today announced the company has entered into an licensing agreement with the Russian pharmaceutical company Binnopharm Group, for 9MW0113, 9MW0321 and 9MW0311, its Adalimumab and Denosumab biosimilars, under which Binnopharm Group will have exclusive rights to develop, register, manufacture and market the drugs with a status of local product in Russia and Eurasian Economic Union countries

35. Canada’s Largest Public Drug Plan Announces Transition To Cost-Saving Biosimilar Medicines 12/20/2022

    Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, today welcomed the announcement by Ontario Health Minister Sylvia Jones that the province will implement a “switching” or transitioning policy to expand the use of biosimilar biologic medicines for the Ontario Drug Benefit (ODB) program in 2023.

36. Ontario Expanding Safe Use Of Biosimilars 12/20/2022

    Ontario is joining several other provinces and territories by expanding the use of biosimilar drug treatments for Ontarians. Starting March 31, 2023, Ontario Drug Benefit (ODB) recipients who are on an originator biologic will begin to transition to a Health Canada approved biosimilar version of the drug at no cost.

37. Dr. Reddy’s Successfully Completes Phase 1 Study Of DRL_TC, A Proposed Biosimilar Of Tocilizumab 12/19/2022

    Dr. Reddy’s Laboratories Ltd. DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 study.

38. Paras Biopharmaceuticals Creates Excellence With ‘Continuous Biomanufacturing’: Achieves Objectives Of ‘High Productivity & Biomanufacturing Innovation’ 12/19/2022

    With 6 years of dedicated work at Paras Biopharmaceuticals and the use of Paras Biopharmaceuticals’ unique technology platform (which comprises of Bioproduction technologies for economical production of biologics), the company is pleased to announce that an excellent scale-up production process is achieved with “Continuous Biomanufacturing”. These developments are described at https://www.parasbiopharma.com/biosimilars/biosimilars.

39. Prime Therapeutics To Retain Humira® Alongside Biosimilars On NetResults™ Formulary In 2023 12/16/2022
40. Xbrane Provides An Update On Ranibizumab Biosimilar Candidate FDA Filing 12/15/2022

    Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") updates the timing for re-submission of the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS to first quarter of 2023.