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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 Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis) 

Shots:  The CHMP has recommended Samsung Bioepis’ Byooviz  (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26  Byooviz 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 to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…
December 2, 2025

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NEWS

Cosmo and Glenmark Reports the EC Approval on Winlevi to Treat Acne Vulgaris Across 17 countries in EU 

 Shots:  The EC has approved Cosmo Pharmaceuticals and Glenmark Pharmaceuticals’ Winlevi (clascoterone 10 mg/g cream) for the Treatment of Acne Vulgaris in 17 countries in Europe  Winlevi is authorized in the EU for treating acne vulgaris in adults and adolescents aged 12 to <18 years, with adolescent use limited to facial application  Following approval, Glenmark will begin commercializing Winlevi across 17 European countries, including Belgium, France, Spain,…
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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INSIGHTS+

Disease of the Month – Telangiectasia 

Shots:  Telangiectasia refers to the presence of small, visible red blood vessels, often called broken capillaries, that appear close to the surface of the skin. While common, they are often misunderstood, making awareness and early understanding essential  At PharmaShots, our Disease of the Month report is crafted to make complex medical information accessible and relevant…
November 26, 2025

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NEWS

Formycon Launches Epruvy (Biosimilar, Lucentis) in the Germany

Shots:  Sandoz commercializes Epruvy (Biosimilar, Lucentis) across Germany in PFS and vial forms, following an agreement with Formycon and Bioeq   Epruvy (ranibizumab)was approved by the EMA in Sep'24 to treat severe visual impairments like nAMD and other retinopathies and is marketed by Sandoz in Germany under a Bioeq license   Epruvy is available in vials and pre-filled syringes, offering a convenient treatment option in Germany  Ref: Formycon | Image: Formycon  | Press Release Related…
November 20, 2025

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NEWS

Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)   

Shots:  The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026   The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy  Intas has an exclusive…
November 20, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in October 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 October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…
November 18, 2025

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