FDA Approves Imuldosa
FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara
RALEIGH, N.C., Oct. 14, 2024 /PRNewswire/ -- 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.
Stelara 's annual worldwide sales in 2023 amounted to $10.86 billion, underscoring the significant market potential for Imuldosa . 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 patients," said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. "As our presence in the biosimilar market continues to grow, so does our commitment to offering high quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need to thrive."
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.
Imuldosa Indications and Important Safety Information
Infections
- Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.
- Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:
- Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections.
- Psoriatic arthritis: cholecystitis.
- Crohn's disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
- Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
- Avoid initiating treatment with Imuldosa in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Imuldosa in patients with a chronic infection or a history of recurrent infection.
- Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Imuldosa and discontinue Imuldosa for serious or clinically significant infections until the infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular Infections
- Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.
- It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances).
Pre-treatment Evaluation for Tuberculosis
- Evaluate patients for tuberculosis infection prior to initiating treatment with Imuldosa . Avoid administering Imuldosa to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering Imuldosa . Consider anti-tuberculosis therapy prior to initiation of Imuldosa in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Imuldosa for signs and symptoms of active tuberculosis during and after treatment.
Malignancies
- Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.
- The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
- There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving Imuldosa for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment.
Hypersensitivity Reactions
- Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Imuldosa .
Posterior Reversible Encephalopathy Syndrome (PRES)
- Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.
- Monitor all patients treated with Imuldosa for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Imuldosa .
Immunizations
- Prior to initiating therapy with Imuldosa , patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Imuldosa should not receive live vaccines. Avoid administering BCG vaccines during treatment with Imuldosa or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Imuldosa because of the potential risk for shedding from the household contact and transmission to patient.
- Non-live vaccinations received during a course of Imuldosa may not elicit an immune response sufficient to prevent disease.
Noninfectious Pneumonia
- Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue Imuldosa and institute appropriate treatment
Most Common Adverse Reactions
The most common adverse reactions associated with ustekinumab products are:
- Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue
- Crohn's Disease, induction (≥3%): vomiting
- Crohn's Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis
- Ulcerative colitis, induction (≥3%): nasopharyngitis
- Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea
INDICATIONS
Imuldosa is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
- moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
- active psoriatic arthritis (PsA)
- moderately to severely active Crohn's disease (CD)
- moderately to severely active ulcerative colitis
Pediatric patients 6 years and older with:
- moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
- active psoriatic arthritis (PsA)
For more information, please see the full Prescribing Information.
About Accord BioPharma
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com.
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 Janssen Biotech Inc.
SOURCE Accord BioPharma
Posted: October 2024
Imuldosa (ustekinumab-srlf) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.