Biosimilar Development News
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Sandoz Announces Collaboration With mAbxience To Expand Patient Access To Life-Enhancing Biosimilar Medicines
9/18/2026
Sandoz, the global leader in affordable medicines, today announces a licensing, development, manufacturing and commercialisation agreement with mAbxience, marking another significant step to broaden patient access to high-quality biosimilar medicines worldwide.
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Henlius HANDAYUAN Received DRAP Approval In Pakistan
9/16/2026
Shanghai Henlius Biotech, Inc. announced that the company’s business partner Getz Pharma (Private) Limited (Getz Pharma) has received the relevant registration certificates from the Drug Regulatory Authority of Pakistan (DRAP) for the approval of Henlius’ self-developed and manufactured adalimumab biosimilar HANDAYUAN under the trade name Adaliget, covering all indications of the reference biological product approved in Pakistan.
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Shilpa Biologicals And SPIMACO Bio Sign Strategic License Agreement For PD-1 Biosimilar For MENA Market
9/16/2026
Shilpa Biologicals Private Limited, an integrated biologics development and manufacturing organisation, announces an exclusive Middle East and North Africa (MENA) strategic licensing and commercialization agreement with SPIMACO Bio of Saudi Arabia for portfolio of PD-1 inhibitor biosimilars across the Middle East and North Africa (MENA).
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Dr. Reddy's Laboratories Launches NIVORZ (Nivolumab Biosimilar) In India
9/15/2026
Dr. Reddy’s Laboratories Ltd. today announced the launch of NIVORZ (Nivolumab Biosimilar) in India. NIVORZ is a biosimilar to Opdivo (nivolumab).
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Bio Usawa And Axmed Partner To Expand Access To Affordable Biologic Medicines Across Africa
9/14/2026
Bio Usawa and Axmed have entered into a strategic collaboration to expand patient access to advanced, affordable biologic medicines across African health systems.
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Indian Pharmacopoeia Commission (IPC) Organizes National Conference On Quality And Safety Of Biosimilars: Strengthening India's Biopharma SHAKTI Vision
9/11/2026
The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India, organized a two-day National Conference on “Quality and Safety of Biosimilars: Strengthening India’s Biopharma SHAKTI Vision” on September 10–11, 2026, at the Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru.
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U.S. Generic & Biosimilar Medicines Save $496B In Just 1 Year
9/10/2026
The Association for Accessible Medicines and the Biosimilars Council today released the 2026 U.S. Generic & Biosimilar Medicines Savings Report – Forward for America. AAM’s annual savings report highlights that generic and biosimilar medicines created $496B in savings in 2025 for patients and the overall healthcare system.
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Henlius Open Day 2026: Systematic Global Expansion Drives C-MNC Vision, Innovation Fuels New Peaks
9/9/2026
Henlius successfully hosted its Open Day 2026 event with great fanfare. The company's management team gathered together with leading experts and scholars from across the industry to engage in in-depth discussions centered on Henlius's "Globalization 2.0" strategy, the global value of biosimilars, the latest advancements in innovative R&D, future strategic planning, and cutting-edge technology and therapeutic modalities.
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Sandoz Invests In New Drug Substance Facility In Ljubljana, Slovenia, To Expand Biosimilar Manufacturing Capacity
9/8/2026
Sandoz, the global leader in affordable medicines, today announces plans to build a new biosimilar drug substance facility in Ljubljana, Slovenia.
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Samsung Bioepis Gains Marketing Approval In Japan For 130mg Intravenous Infusion Of Ustekinumab Biosimilar
9/3/2026
Samsung Bioepis Co., Ltd. today announced the marketing approval of Ustekinumab BS Intravenous Infusion 130mg 「NIPRO」, a biosimilar referencing Stelara1 (ustekinumab), indicated for an induction therapy for moderate-to-severe active Crohn’s disease where other treatments are ineffective.