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NEWS

Jacobio Pharma Forge ~$2B+ Partnership with AstraZeneca for JAB-23E73

Shots: Jacobio Pharma entered a global exclusive licensing agreement with AstraZeneca for JAB-23E73, granting AstraZeneca exclusive development & commercialization rights outside China, while both companies will jointly develop & commercialize in China As per the deal, Jacobio will receive $100M upfront, and is eligible up to $1.91B in development & commercial milestones, and tiered royalties…
December 22, 2025

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NEWS

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval 

 Shots:  The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva  Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications   Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights  Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…
December 22, 2025

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INSIGHTS+

The US FDA New Drug Approvals in November 2025 

Shots:  Innovation surged in November, with cutting-edge science and strategic collaborations reshaping the drug development landscape across oncology, renal disease, hereditary conditions, and more  The US FDA cleared five standout therapies, including Bayer’s Hyrnuo (Sevabertinib), UCB’s Kygevvi (Doxecitine + Doxribtimine), and Arrowhead’s Redemplo, underscoring a month of meaningful clinical progress  November 2025 closed with five approvals, matching last year’s total, signaling sustained momentum and a steady…
December 9, 2025

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NEWS

Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Shots: Crescent granted Kelun exclusive rights to research, develop, manufacture & commercialize CR-001 in Greater China, while Kelun granted Crescent similar exclusive rights for SKB105 globally (excl. Greater China) Kelun will receive $80M upfront, ~$1.25B in milestones, tiered mid–single to low-double-digit royalties & potential change-of-control payments, while Crescent will get $20M upfront, ~$30M in milestones…
December 5, 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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Samsung Bioepis
NEWS

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…
December 1, 2025

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NEWS

The US FDA Approves Lupin’s Armlupeg (Biosimilar, Neulasta) 

Shots:  The US FDA has approved Armlupeg (pegfilgrastim-unne) as a biosimilar version of Neulasta (pegfilgrastim)   Armlupeg (6 mg/0.6 mL) is administered as a single-dose SC injection. It is indicated to reduce the incidence of febrile neutropenia in pts with non-myeloid cancers undergoing myelosuppressive CT and to improve survival following acute myelosuppressive radiation exposure   Armlupeg will be produced at Lupin’s Biotech facility…
December 1, 2025

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