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INSIGHTS+

Key Biosimilars Events of December 2025  

Shots:        Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications  Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon,…
January 6, 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

CivicaScript Launches Insulin Glargine-yfgn and Ustekinumab-aauz (Biosimilar, Lantus and Stelara) in the US  

Shots:  CivicaScript has reported that Insulin Glargine-yfgn and Ustekinumab-aauz, biosimilar versions of Lantus and Stelara, are now available in the US  Civica insulin glargine-yfgn is an interchangeable Lantus® insulin for adults and children with diabetes, developed through a Civica-led collaboration. It is marketed nationally by CivicaScript and branded as CalRx in California through the state’s CalRx program  Ustekinumab-aauz is an IL-12/23 antagonist indicated for select…
January 5, 2026

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NEWS

Denali Therapeutics Announces Publishing of P-I/II Study of Tividenofusp Alfa (DNL310) in NEJM for Hunter Syndrome (MPS II)

Shots: The NEJM published results from the P-I/II study of Denali Therapeutics’ tividenofusp alfa (DNL310) for the treatment of Hunter syndrome (MPS II) The study evaluated treatment in 47 ERT-naïve (n=15) and previously treated (n=32) study participants (aged 0.3–13 [median, 5] years) demonstrating reduced levels of mean CSF levels of HS, mean urine HS levels,…
January 2, 2026

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NEWS

BioAtla and GATC Health Announce $40M SPV Transaction to Advance Ozuriftamab Vedotin into P-III Study for 2L+ OPSCC

Shots: BioAtla and GATC Health announce  into a $40M special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC, into a registrational P-III study for 2L+ oropharyngeal squamous cell carcinoma (OPSCC) Under the agreement, BioAtla will receive $5M upfront to support operations and P-III study execution, with the remaining $35M expected to close…
January 2, 2026

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Samsung Bioepis
NEWS

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
January 2, 2026

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NEWS

Delcath Systems Publishes Subgroup Analyses of The P-III Study on Unresectable Metastatic Uveal Melanoma Patients

Shost: Delcath Systems has reported the publication of subgroup analyses from the Phase 3 (FOCUS) study in the Journal of Cancer Research and Clinical Oncology, evaluating the efficacy and safety of the HEPZATO KIT on melphalan/hepatic delivery in pts with unresectable metastatic uveal melanoma In the subgroup analyses (n=91) of the P-III (FOCUS) Study pts,…
January 2, 2026

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NEWS

Intelligent Bio Solutions and Syrma Johari MedTech Collaborate to Advance Global Production Capability and Margin Expansion

Shots: Intelligent Bio Solutions has entered into a strategic manufacturing partnership with Syrma Johari MedTech to scale production of its Intelligent Fingerprinting Drug Screening Reader and support long-term margin improvement Under the agreement, the partnership advances INBS’ global manufacturing strategy by diversifying suppliers, strengthening supply chain resilience, expanding capacity, and increasing flexibility ahead of anticipated multi-region…
January 2, 2026

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