FDA-approval granted to Accord BioPharma’s IMULDOSA®
The U.S. Food and Drug Administration (FDA) has approved IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. This approval comes from Accord BioPharma (NC, USA), a division of Intas Pharmaceuticals (Ahmedabad, India), adding to their growing biosimilar portfolio.
Approval of IMULDOSA was granted based on a comprehensive clinical development program, with the data showing that IMULDOSA is similar to its reference product STELARA in terms of pharmacokinetic characteristics, safety, tolerability and efficacy and that IMULDOSA adheres to current biosimilar guidance from the FDA.
“For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs,” explained Chrys Kokino, U.S. President of Accord BioPharma. “The approval of IMULDOSA, our second biosimilar, is evidence of our growing momentum in the industry and our leadership in supporting families with accessible options to address urgent and critical medical conditions.”
IMULDOSA has the potential to be an affordable treatment option for those suffering from chronic inflammatory conditions, offering similar benefits to the current standard of care. It also marks the second FDA-approved biosimilar from Accord BioPharma, the first being HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin®, which was approved earlier in 2024. In addition to IMULDOSA and HERCESSI, Accord BioPharma plans to introduce several additional biosimilars to the U.S. market during the next 5 years.
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Binish Chudgar, Executive Chairman of the Board at Intas Pharmaceuticals, explained:
“We’re proud to add IMULDOSA to our U.S. biosimilar portfolio, which represents an affordable treatment option for patients living with painful inflammatory conditions. It is Accord BioPharma’s goal to go beyond biology and continuously work to provide affordable world class treatments to the patients. As our presence in the biosimilar market continues to grow, so does our commitment to offering high quality, affordable and effective alternatives to reference drugs, to the patients in need.”
