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news.Biocon Biologics, a subsidiary of Biocon, has launched Yesintek (ustekinumab-kfce), a biosimilar to Stelara, in the US.
The therapy gained approval for treating Crohn's disease and ulcerative colitis among others. Credit: derneuemann on Pixabay.
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Yesintek is claimed to be one of the first Stelara (ustekinumab) biosimilar market entrants in the US.
The therapy gained approval for treating various conditions which includes Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
It is available in the same formulations as Stelara, including 45 mg/0.5 ml PFS, 90 mg/ml PFS, 45 mg/0.5 ml vial, and 130 mg/26 ml vial.
Biocon Biologics CEO and managing director Shreehas Tambe said: “The launch of Yesintek marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars.
“It also represents our first product launch in the US since becoming a fully integrated global biosimilars organisation. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population.”
At its launch, the monoclonal antibody will be covered by commercial payors and also have a patient assistance programme.
Biocon stated that the copay programme is “competitive with the originator offering” and patients that meet the programme criteria need not pay anything.
Yesintek targets the mediated signalling of interleukin 12 (IL-12) and IL-23, which is related to the immune-mediated conditions.
Clinical studies indicate that Yesintek has similar safety, efficacy, immunogenicity, and pharmacokinetic profile to that of Stelara.
In December last year, the US Food and Drug Administration (FDA) granted approval for the antibody.
The approval was supported by a comprehensive nonclinical, clinical, and analytical data package determining that Yesintek is extremely similar to its reference, Stelara.
The Phase III STELLAR-2 trial compared the antibody with its reference in individuals with moderate-to-severe chronic plaque psoriasis.
Findings indicated no clinically meaningful differences between the two in terms of pharmacokinetics, efficacy, immunogenicity, and safety.
