FDA Approves IMULDOSA® (ustekinumab-srlf), Accord BioPharma's Biosimilar to STELARA® (ustekinumab), for the Treatment of Chronic Inflammatory Conditions

PRNewswire
Ahmedabad (Gujarat) [India], October 14: Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that 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. The FDA approved IMULDOSA for all indications of its reference medicine, STELARA. Accord anticipates a commercial launch of IMULDOSA in the first half of 2025.
"For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs," said Chrys Kokino, U.S. president of Accord. "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."
For the millions of Americans living with chronic inflammatory conditions, which can be painful, and also can have a significant impact on quality of life, emotional well-being, and self-image, IMULDOSA has the potential to be an affordable treatment option that provides similar benefits to the current standard of care. It also marks the second biosimilar to be FDA-approved from Accord BioPharma, arriving shortly after the approval of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin®, earlier this year.
FDA approval of IMULDOSA was granted based on a comprehensive clinical development program. The data showed 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.
"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," said Binish Chudgar, Executive Chairman of the Board, Intas Pharmaceuticals. "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."
IMULDOSA was initially developed as DMB-3115 in 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. In 2021, Intas Pharmaceuticals acquired exclusive commercialization rights to DMB-3115 through a license agreement. As a global subsidiary of Intas Pharmaceuticals, Accord BioPharma will be responsible for U.S. commercialization of IMULDOSA.
In addition to IMULDOSA and HERCESSI, Accord BioPharma is planning on introducing several additional biosimilars to the U.S. market during the next five years.
References:
1. IMULDOSA (ustekinumab-srlf). Prescribing Information. Accord BioPharma; October 2024.
2. Johnson & Johnson Reports: Q4 and Full-Year 2023 Results.
3. Pahwa R, Goyal A, Jialal I. Chronic Inflammation. StatPearls Publishing; 2023.
4. Beese SE, Harris IM, Dretzke J, Moore D. Body image dissatisfaction in patients with inflammatory bowel disease: a systematic review. BMJ Open Gastroenterol. 2019 Feb 16;6(1):e000255.
5. Accord BioPharma. Data on file.
STELARA® is a registered trademark of Johnson & Johnson.
Contact:
Vibhuti Bhatt
Director
Email ID: vibhutibhatt@oneadvt.com
About Intas
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US.
Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US.
Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently; Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products.
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