Biosimilar Development News
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Samsung Bioepis Presents Phase 1 Study Results Of SB17 (Ustekinumab), A Proposed Biosimilar To Stelara, At 2023 AAD Annual Meeting
3/17/2023
Samsung Bioepis Co., Ltd. today announced that SB17, a proposed biosimilar to Stelara1 (ustekinumab), demonstrated pharmacokinetic (PK) bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in Phase 1 clinical study with healthy volunteers.
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Stevanato Group Collaborates With Recipharm To Develop And Manufacture Pre-Fillable Syringes For Use In A New Soft Mist Inhaler For The Inhalation Of Sensitive Biological Products
3/16/2023
The new strategic collaboration aims to provide innovative primary packaging to pharmaceutical and biopharmaceutical companies using Recipharm’s proprietary soft mist inhalers.
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Sandoz Signs Memorandum Of Understanding To Build New Biologics Production Plant In Slovenia, To Support Increasing Global Demand For Biosimilar Medicines
3/9/2023
Sandoz, a global leader in generic and biosimilar medicines, today signed a Memorandum of Understanding (MOU) to build a new biologics production plant in Lendava, Slovenia.
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Biosimilars Canada Announces Board Chair And Vice-Chair
3/9/2023
Biosimilars Canada is pleased to announce the unanimous election of Mr. Mike Woolcock, Senior Vice President of the Apobiologix division of Apotex, as Chair of the Biosimilars Canada Board.
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Global Rituximab Biosimilars Market Report 2023: Major Players Include Pfizer, Mylan, Amgen, Teva Pharmaceutical Industries And Celltrion Healthcare
3/7/2023
The "Rituximab Biosimilars Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering.
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Biosimilars Key To Lowering Drug Prices; National Alliance Of Healthcare Purchaser Coalitions Releases Playbook To Help Employers Adopt
3/7/2023
Broader acceptance and use of biosimilars – lower-cost versions of patented and branded drugs – by employers and other healthcare purchasers are key to preserving economic competition in the marketplace.
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FDA Approves UDENYCA® Autoinjector
3/6/2023
Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) approved a single-dose, prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
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Participants Dosed On Adessia In Germany In A Phase 1 Trial, A First For An Adalimumab Biosimilar Candidate Developed In Africa
3/6/2023
MiGenTra, a Berlin-based healthcare transforming company, reported today that the first participants in a Phase 1 clinical trial for Minapharm Pharmaceuticals adalimumab biosimilar candidate (brand name: Adessia) were dosed on February 24, 2023 in Germany.
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Biosimilars Forum Applauds Congressman Hudson For Supporting Biosimilars Through Shared Savings Legislation
3/3/2023
Juliana M. Reed, executive director the Biosimilars Forum, released the following statement after Congressman Richard Hudson (R-NC) introduced legislation to establish a shared savings reimbursement model for biosimilars in Medicare Part B.
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FDA And FTC Collaborate To Advance Competition In The Biologic Marketplace
3/2/2023
The U.S. Food and Drug Administration regulates biological products, or biologics, which have transformed the treatment of many illnesses and are the fastest-growing class of medications in the U.S. Biologics offer hope and healing to millions of Americans, but they can be expensive.