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Samsung Bioepis and Organon
NEWS

Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada

Shots: Samsung Bioepis & Organon have expanded their development & commercialization agreement for Pyzchiva, a biosimilar version of Stelara (ustekinumab), with launch expected in 2026 As per the deal, Organon will gain exclusive commercialization rights to Pyzchiva in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, & regulatory activities. The addition of Pyzchiva expands the…
3 days ago

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NEWS

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…
May 20, 2026

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TOP 20

Top 20 Biopharma Companies of 2026    

Shots: The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
April 10, 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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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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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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Celltrion
NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…
December 18, 2025

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NEWS

Samsung Bioepis & Johnson & Johnson have Entered into an Agreement for the Commercialization of Pyzchiva (Biosimilar, Stelara) Across EU 

Shots:  Samsung Bioepis has signed a confidential settlement and license agreement with Johnson & Johnson for the commercialization of Pyzchiva, its Stelara (ustekinumab) biosimilar in Europe  Ustekinumab is an IgG1κ monoclonal antibody targeting IL-12 and IL-23. PYZCHIVA, developed by Samsung Bioepis, received European Commission approval as a Stelara biosimilar in April 2024  PYZCHIVA was introduced in the EU by Sandoz in July…
November 6, 2025

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Biocon Biologics
NEWS

Biocon Biologics Receives Health Canada Approval for Yesintek & Yesintek IV (Biosimilar, Stelara)  

Shots:  Biocon Biologics has received Health Canada’s NOC for Yesintek & Yesintek IV, biosimilars to Stelara, with approval on Oct 17 and commercial availability expected in mid-October  Approval was supported by data showing YESINTEK is highly similar to Stelara with no meaningful differences in efficacy, safety, or immunogenicity. It will be offered via the My…
October 23, 2025

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