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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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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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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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TOP 20

Top 20 Generic Pharma Companies of 2025 

Shots:  Generic medicines play a pivotal role in offering cost-effective alternatives to high-priced pharmaceuticals. They often serve as a critical lifeline in developing and underdeveloped nations, helping to address both chronic and infectious diseases.  In 2024, the global generics market was valued at $445.62B, with projections to reach approximately $468.08B in 2025 and ~$728.64B by…
October 8, 2025

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NEWS

Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC  

Shots:  Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara  The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis  Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…
August 18, 2025

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VIEWPOINTS

Enhancing Accessibility to Medicine: Joshua Salsi from Biocon Biologics in Conversation with PharmaShots 

Shots:  Biocon Biologics’ Yesintek, biosimilar to Stelara, has secured broad market access through inclusion in the formularies of all major pharmacy benefit managers (PBMs)  Yesintek offers strong financial support and a smooth transition process, positioning it as a preferred option for patients needing ustekinumab therapy  Joshua Salsi, Head of North America Commercial at Biocon Biologics,…
August 4, 2025

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Bio-Thera New
NEWS

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots: The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product Opinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK &…
June 23, 2025

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