Ustekinumab biosimilar (Accord BioPharma)

The European Medicines Agency’s human medicines committee again decided not to recommend the renewal of the conditional marketing authorization for PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna. The treatment has gone through multiple reviews by the committee. Friday’s decision is the fourth time the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended against the drug. The CHMP first decided against Translarna in September 2023, then confirmed that decision in January 2024, following a re-examination requested by PTC Therapeutics. In June, the committee reviewed the drug after the European Commission asked the committee to consider additional data — but the committee’s decision remained the same. PTC Therapeutics asked the committee again to reconsider in July, which led to this fourth decision. Since its initial authorization in 2014, PTC Therapeutics has carried out two more studies in an attempt to show the drug’s effectiveness. The first study failed to confirm the efficacy of the treatment, though the data suggested that a subgroup of patients — those with a progressive decline in their ability to walk — might see more efficacy. A second study did not reach statistical significance in that subgroup of patients. The drug will remain available while the EMA reviews CHMP’s recommendation. “CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna,” PTC Therapeutics CEO Matthew Klein said in a statement . Leerink Partners wrote Friday that they expect this to be “the final negative opinion,” adding that although PTC Therapeutics resubmitted an NDA to the FDA in late July, there have been no more updates in the US, and they “remain skeptical on the likelihood of US approval.” In addition to the Translarna decision, here’s a look at the medicines that CHMP recommended ahead of a potential thumbs-up from the European Commission:

With the approval of IMULDOSA, Accord BioPharma's biosimilar portfolio continues to grow while expanding treatment options appropriate for patients 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 IMULDOSA 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. Contact: [email protected] SOURCE Accord BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED