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Sandoz
NEWS

Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)

Shots: The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027 Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy In Dec 2018, Sandoz partnered with…
January 15, 2026

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Fresenius Kabi
NEWS

Fresenius Kabi Launches an Additional Presentation of Otulfi (Biosimilar, Stelara)

Shots: Fresenius Kabi has launched Otulfi, an interchangeable biosimilar version of Stelara (ustekinumab), in a 45 mg/0.5 mL single-dose vial presentation for SC injection FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev.…
January 7, 2026

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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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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

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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NEWS

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
December 25, 2025

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Samsung Bioepis
NEWS

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan 

Shots:  Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation  Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026   It is also approved in Australia, Brazil, Canada,…
December 23, 2025

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NEWS

Biocon Biologics Signs In-Licensing Agreement with Yowa Kirin Biologics for Hulio (Biosimilar, Humira) 

Shots:  Biocon Biologics secured full global rights to Hulio (Adalimumab), a biosimilar of adalimumab, from Fujifilm Kyowa Kirin Biologics  As per the agreement, Biocon Biologics will take full responsibility for manufacturing, commercialization, and further development, while FKB will support development, offset certain development costs, and receive technology license fees and royalties for a specified tenure  Biocon Biologics…
December 23, 2025

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NEWS

Alvotech Reports the European Launch of Gobivaz (Biosimilar, Simponi)

Shots: Alvotech has reported the launch of Gobivaz (AVT05), a biosimilar version of Simponi (golimumab) for the treatment of several chronic inflammatory diseases, with commercialization led by Advanz Pharma In the UK, Gobivaz’s launch is supported by an NHS England tender award, while rollout across EEA markets will advance in line with country-specific pricing, reimbursement…
December 23, 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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