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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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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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Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025
The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…
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Biocon Biologics has launched Yesintek (ustekinumab- kfce), a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial
The approval was…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
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The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab)
Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen
Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…

