Accord BioPharma, Inc., a U.S. division of
Intas Pharmaceuticals focused on oncology, immunology, and critical care treatments, recently announced that the FDA has approved
IMULDOSA (ustekinumab-srlf), a biosimilar to
STELARA® (ustekinumab). This approval covers all the same chronic inflammatory conditions as its reference drug, including
psoriasis,
psoriatic arthritis,
Crohn's disease, and ulcerative colitis. IMULDOSA is expected to be launched commercially in the first half of 2025.
STELARA, the reference drug, had impressive global sales of $10.86 billion in 2023, indicating a significant market opportunity for IMULDOSA. Chrys Kokino, the U.S. president of Accord, commented that this approval represents a significant milestone in providing affordable treatment alternatives to meet patient needs. This approval is Accord's second biosimilar, following the recent approval of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin®.
IMULDOSA’s FDA approval was based on extensive clinical trials that demonstrated its equivalence to STELARA in terms of pharmacokinetics, safety, tolerability, and efficacy. The company claims that IMULDOSA adheres to current FDA biosimilar guidelines.
Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals, expressed pride in adding IMULDOSA to Accord's biosimilar lineup. He emphasized the company's aim to offer high-quality, affordable treatment options to patients, underscoring their growing presence in the biosimilar market.
IMULDOSA, initially developed as DMB-3115 by Dong-A Socio Holdings and Meiji Seika Pharma in 2013, was acquired by Intas Pharmaceuticals in 2021 through a licensing agreement for exclusive commercialization rights. Accord BioPharma will handle the U.S. commercialization of IMULDOSA.
Looking ahead, Accord BioPharma plans to introduce several more biosimilars to the U.S. market over the next five years.
IMULDOSA is indicated for treating various chronic inflammatory conditions in both adults and pediatric patients aged six and older. However, it comes with several safety warnings. Ustekinumab products, including IMULDOSA, may increase the risk of infections and reactivation of latent infections. Serious infections reported in clinical trials include diverticulitis, cellulitis, sepsis, pneumonia, and more. Patients should be evaluated for tuberculosis prior to starting IMULDOSA, and treatment should be avoided in patients with active tuberculosis. The drug may also elevate the risk of malignancies and hypersensitivity reactions, including anaphylaxis.
Additionally, there is a theoretical risk for particular infections in individuals genetically deficient in IL-12/IL-23, who may be vulnerable to infections from mycobacteria, salmonella, and BCG vaccinations. Patients treated with IMULDOSA should receive all age-appropriate immunizations before starting therapy. Live vaccines should be avoided during treatment, and caution is advised when administering vaccines to household contacts of patients receiving IMULDOSA.
Non-live vaccines administered during IMULDOSA treatment may not provide adequate disease protection. There have been reports of noninfectious pneumonia and cases of posterior reversible encephalopathy syndrome (PRES) in patients using ustekinumab products. Therefore, patients need to be monitored for signs of these conditions.
Finally, common adverse reactions to ustekinumab products include nasopharyngitis, upper respiratory tract infections, headaches, and fatigue, among others.
Accord BioPharma, Inc., aims to make high-quality, affordable therapies accessible to more patients, enhancing the overall patient experience and addressing critical medical needs. Their biosimilar portfolio is rapidly expanding, with a focus on providing cost-effective alternatives to high-priced biologics.
How to obtain the latest research advancements in the field of biopharmaceuticals?
In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!
