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INSIGHTS+

Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
April 7, 2026

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NEWS

Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics

Shots: Alteogen has granted Biogen exclusive rights to ALT-B4 (berahyaluronidase alfa) to develop & commercialize SC formulations of two biologics, with an option for Biogen to develop a third product As per the deal, Alteogen will receive $20M upfront, $10M upon initiation of second product development, along with ~$549M in development, regulatory, & sales milestones…
March 26, 2026

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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
March 3, 2026

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INSIGHTS+

Key Biosimilars Events of January 2026   

Shots:  Global biosimilar activity accelerated across ophthalmology, oncology, immunology, and diabetes, with new or advancing alternatives to Lucentis, Eylea, Stelara, Lantus, Avastin, Opdivo, and Neulasta, expanding patient access across Europe, the US, India, Canada, Ghana, and MENA  Regulatory and commercialization momentum remained strong, marked by FDA, EC, Health Canada, and Ghana FDA milestones, alongside Samsung Bioepis’…
February 3, 2026

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NEWS

Boehringer Ingelheim and Simcere Pharmaceutical ~$1.26B Deal to Develop SIM0709

Shots: Boehringer Ingelheim and Simcere have entered a license and collaboration agreement to develop SIM0709, a preclinical TL1A/IL-23p19 bispecific antibody, for the treatment of inflammatory bowel disease (IBD) As per the deal, Boehringer Ingelheim gains global rights to the asset excluding Greater China, while Simcere is eligible for an upfront payment, milestones up to €1.058B…
January 28, 2026

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INSIGHTS+

2025 Drug Approvals Outlook: A Year of Precision Across Therapeutic Frontiers 

Shots: Precision, convenience, and disease modification define 2025 drug approvals as regulators reward biologically clear, patient-specific therapies that fragment legacy markets, elevate rare diseases, and prioritize meaningful outcomes over broad labels. Innovation is shifting from complexity to usability with oral, subcutaneous, topical, and on-demand therapies improving access and adherence across neurology, cardiology, endocrinology, ophthalmology, and…
January 6, 2026

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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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Elanco
NEWS

Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…
January 1, 2026

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NEWS

Samsung Biologics Expands U.S. Manufacturing Footprint with Acquisition of Human Genome Sciences from GSK

Shots: Samsung Biologics’ US subsidiary entered a definitive agreement to acquire 100% of Human Genome Sciences from GSK, securing its first US based manufacturing site in Rockville, Maryland As per the deal terms, Samsung Biologics will acquire the Rockville assets for $280M, with closing expected by end of Q1’26, while retaining 500+ employees to ensure…
December 22, 2025

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