NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…

ByDipanshu DixitFebruary 20, 2026

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’…

ByDipanshu DixitFebruary 3, 2026

NEWS

Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand

Shots: Alvotech has entered into supply & commercialization agreements with Sandoz for multiple biosimilar candidates across Canada, Australia, & New Zealand In Canada, the deal includes one ophthalmology biosimilar in a prefilled intravitreal syringe, while in Australia & New Zealand, it covers 3 biosimilar candidates across immunology & gastroenterology in multiple formulations As per the…

ByRidhi RastogiFebruary 2, 2026

NEWS

Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea)

Shots: Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…

ByDipanshu DixitJanuary 29, 2026

NEWS

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Shots: The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU) The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05 NOV05 is…

ByPrince GiriJanuary 27, 2026

NEWS

Ocugen Reports Positive Preliminary P-II (ArMaDa) Data of OCU410 in Geographic Atrophy (GA) Secondary to Dry AMD

Shots: Ocugen has reported preliminary 12mos. data from its P-II (ArMaDa) trial (n=51) of OCU410 (AAV5-RORA) in GA secondary to dry AMD, with ~50% of pts evaluated to date Trial showed a 46% reduction in GA lesion growth vs control (medium + high dose), with the medium dose achieving a 54% reduction; 50% pts achieved…

ByRidhi RastogiJanuary 16, 2026

NEWS

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Shots: The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab) BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…

ByDipanshu DixitJanuary 13, 2026

NEWS

Bio Usawa Receives the Ghana FDA Approval for BioUcenta (Biosimilar, Lucentis)

Shots: The Ghana FDA has approved BioUcenta, a biosimilar version of Lucentis (ranibizumab) for diabetic macular edema, age-related macular degeneration, and diabetic retinopathy The Ghana FDA approval followed a rigorous, science-based review referencing comprehensive data previously evaluated and accepted by the EMA BioUcenta is exclusively licensed to Bio Usawa for Sub-Saharan Africa by Bioeq AG Ref: Bio Usawa | Image: Bio Usawa | Press Release Related News: CuraTeQ Biologics Reports Positive P-III study…

ByDipanshu DixitJanuary 12, 2026

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…

ByDipanshu DixitJanuary 2, 2026

NEWS

Outlook Therapeutics Shares Update on FDA Review of ONS-5010/Lytenava for Wet AMD

Shots: The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of…

ByDipanshu DixitJanuary 1, 2026

NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Key Biosimilars Events of January 2026

Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand

Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea)

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Ocugen Reports Positive Preliminary P-II (ArMaDa) Data of OCU410 in Geographic Atrophy (GA) Secondary to Dry AMD

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Bio Usawa Receives the Ghana FDA Approval for BioUcenta (Biosimilar, Lucentis)

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

Outlook Therapeutics Shares Update on FDA Review of ONS-5010/Lytenava for Wet AMD

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