Pharmaceutical firms launch Stelara biosimilars
Several pharmaceutical companies are unleashing biosimilars to Johnson & Johnson's Stelara.
Teva and Alvotech are offering Selarsdi (ustekinumab-aekn) injection, which is a biosimilar to Johnson & Johnson's Stelara for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis.
This is the second biosimilar now available in the U.S. market under the Teva and Alvotech strategic partnership. The FDA has provisionally determined that Selarsdi will be interchangeable with Stelara, following the expiration of exclusivity for the first interchangeable biosimilar, on April 30, 2025.
“Biosimilars like Selarsdi create opportunities for cost savings across the healthcare system, and we are proud to be able to introduce our second biosimilar treatment option in partnership with Alvotech to U.S. patients and providers,” said Thomas Rainey, senior vice president, U.S. biosimilars at Teva. “The U.S. availability of Selarsdi reinforces Teva’s overall strategy to identify strategic business partners to develop and manufacture biosimilars while leveraging Teva’s commercial presence and experience to bring this and other products to the U.S. market.”
[Read more: FDA accepts Alvotech, Teva's BLAs for Simponi biosimilars]
“The U.S. launch of Selarsdi is an important step for our partnership and reaffirms a joint commitment to providing more affordable treatment options for U.S. patients,” said Anil Okay, chief commercial officer for Alvotech. “Alvotech’s fully integrated approach to development and manufacturing, coupled with our focus on biosimilars, enables us to continue expanding a portfolio of high-quality biologics and contribute meaningfully to lowering healthcare costs world-wide.”
Biocon Biologics is offering Yesintek (ustekinumab-kfce).
Yesintek is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases.
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Yesintek will be available in all the same formulations currently provided by Stelara. 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.
Shreehas Tambe, CEO & managing director of Biocon Biologics 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 United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population."
Laura Wingate, chief education, support & advocacy officer of the Crohn's & Colitis Foundation, said, "The burden of Crohn's disease and ulcerative colitis on patients' daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available."
Yesintek will have commercial payor coverage at launch and also have a robust patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients that meet the program criteria may pay as little as $0, the company said.
Josh Salsi, head of North America, Biocon Biologics, said, "For healthcare providers, switching to Yesintek offers a seamless treatment experience covering the same indications and dosing options. Patients can feel confident that Yesintek comes from Biocon Biologics, a company with extensive biosimilar expertise in immunology."
Sandoz is releasing Pyzchiva (ustekinumab-ttwe). The biosimilar was developed by Samsung Bioepis and commercialized by Sandoz.
Keren Haruvi, president of Sandoz North America, said, “This is an important moment for millions of patients living with chronic autoimmune diseases. The launch of Pyzchiva reinforces our commitment to broaden access to treatment options for patients, while helping to build a more sustainable healthcare system in the U.S. so that everyone can access the medicines they need, when they need them.”
Leah M. Howard, J.D., the president and CEO of the National Psoriasis Foundation, said, “Psoriasis and psoriatic arthritis are chronic diseases that can be treated with biologics, but those medications are often not as accessible or affordable as they should be for those who could benefit most from them. Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them.”
Sandoz said it is providing comprehensive support resources for patients who are prescribed Pyzchiva, including information about insurance coverage/benefit investigation, self-injection training, and a co-pay program for commercially insured patients.
This launch is in accordance with the settlement and license agreement with Johnson & Johnson for the U.S. market, previously announced by Samsung Bioepis. Sandoz entered into a commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva in the United States, Canada, the European Economic Area, Switzerland, the UK and Brazil. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.