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NEWS

Mabwell’s Adalimumab Injection (Biosimilar, Humira) Granted Marketing Approval in Indonesia

Shots: Mabwell’s Adalimumab Injection 9MW0113 (marketed as JUNMAIKANG in China), a Humira biosimilar, has received marketing authorization from Indonesia’s BPOM Adalimumab Injection 9MW0113, co-developed by Mabwell and Junshi Biosciences. Mabwell has submitted registration applications in multiple countries, including Jordan and Peru, and has agreements in over ten markets Adalimumab is a TNF blocker, binds TNF‑alpha…
January 1, 2026

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NEWS

Biocon Biologics Signs In-Licensing Agreement with Yowa Kirin Biologics for Hulio (Biosimilar, Humira) 

Shots:  Biocon Biologics secured full global rights to Hulio (Adalimumab), a biosimilar of adalimumab, from Fujifilm Kyowa Kirin Biologics  As per the agreement, Biocon Biologics will take full responsibility for manufacturing, commercialization, and further development, while FKB will support development, offset certain development costs, and receive technology license fees and royalties for a specified tenure  Biocon Biologics…
December 23, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…
December 16, 2025

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INSIGHTS+

Key Biosimilars Events of November 2025  

Shots:        Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma  Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…
December 2, 2025

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NEWS

EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

Shots: EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology As per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…
October 17, 2025

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NEWS

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Shots: BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio As per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…
October 15, 2025

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NEWS

Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region

Shots: Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology As…
October 8, 2025

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NEWS

Algen Biotechnologies Collaborates with AstraZeneca to Advance Drug Discovery in Immunology

Shots: Algen has entered into a multi-target collaboration with AstraZeneca to accelerate novel immunology target discovery, leveraging the AlgenBrain platform As per the deal, AstraZeneca will receive exclusive rights to develop and commercialize therapies for selected targets identified through the partnership in exchange for ~555M incl. upfront, development, regulatory & commercial milestone payments  AlgenBrain models disease…
October 7, 2025

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NEWS

Monte Rosa Therapeutics Enters a ~$5.7B with Novartis to Develop Degraders for Immune-Mediated Diseases

Shots: Monte Rosa has collaborated with Novartis to develop novel degraders for immune-mediated diseases, leveraging Monte Rosa’s QuEEN discovery engine As per the deal, Novartis will gain an exclusive license to an undisclosed discovery target & options to license 2 programs from Monte Rosa’s preclinical immunology portfolio The deal is valued at ~$5.7B, with Monte…
September 16, 2025

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