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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…
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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…
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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…
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The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product
In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…
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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.…
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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,…
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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 &…
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The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsA
Approval was supported by extensive clinical data, incl. P-III trial of Steqeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change…
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Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan
As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities
Ustekinumab is…
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The US FDA has approved Starjemza (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product
Approval 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…

