Leuprolide Mesylate

Company's third biosimilar expands access to proven targeted biologic therapy with patient-centric support services and resources RALEIGH, N.C., Aug. 18, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced today the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab). IMULDOSA prefilled syringes, which would represent the majority of the presentations in the ustekinumab market, are priced at the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars at a 92% discount from STELARA. FDA-approved for the same indications as the reference product, IMULDOSA represents Accord BioPharma's third in-market biosimilar and furthers the company's mission to expand patient access to potentially life-changing biologic therapies.¹ Accord BioPharma is committed to providing patients with greater access to ustekinumab through this significant cost reduction. This IMULDOSA launch will lay the foundation for Accord BioPharma's immunology franchise, demonstrating the company's commitment to addressing critical needs in immune-mediated inflammatory conditions. Addressing Critical Patient Needs in the U.S. Millions of Americans suffer from chronic, immune-mediated inflammatory conditions, such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.² These conditions are often not only incredibly painful and debilitating, but can also impact a person's quality of life, emotional well-being, and self-image.³⁻⁵ While biologics such as STELARA have had a transformative impact on the lives of many people in the U.S., they often come with a high cost that can prohibit access. Accord BioPharma's ustekinumab biosimilar IMULDOSA has been proven to be highly similar to STELARA with no clinically meaningful differences.¹ Please see below for full Indications and Important Safety Information. As Accord BioPharma prepared for the commercial launch of IMULDOSA, the company solicited feedback from their patient advisory board on the development of patient support materials. The company is grateful for their invaluable input in these co-creation sessions. Expanding Access for Eligible Patients Accord BioPharma has priced IMULDOSA to maximize patient access across all formulations. The prefilled syringes feature the lowest WAC price among branded ustekinumab biosimilars at a 92% discount from STELARA, while the vial formulation offers a 33% discount. Accord BioPharma is launching IMULDOSA with a $0 co-pay program for eligible patients so that more people living with plaque psoriasis, psoriatic arthritis, and Crohn's disease and ulcerative colitis can receive a proven targeted biologic therapy. "At Accord BioPharma, we believe that cost shouldn't be a barrier to accessing proven, life-changing therapies," said Chrys Kokino, Accord U.S. President. "The launch of IMULDOSA represents our commitment to going beyond simply providing biosimilar alternatives to delivering comprehensive solutions that can make a meaningful difference in patients' lives. With our third biosimilar now available, we're demonstrating that Accord BioPharma is at the forefront of biosimilar transformation, backed by the 50-year heritage of our parent company, Intas Pharmaceuticals." Backed by Proven Heritage and Commitment Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market. "The launch of IMULDOSA in the United States represents our unwavering commitment to making high-quality, more cost-effective biologic therapies more accessible within immunology's critical therapeutic areas," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "Through Accord BioPharma, we are establishing ourselves in the U.S. as a trusted, reliable ally highly attuned to the needs of our stakeholders and dedicated to transforming patient care." Current Portfolio of Brands Accord BioPharma's portfolio has experienced sizable growth within the past year. In addition to launching IMULDOSA, Accord BioPharma recently assumed U.S. operations for the full UDENYCA® (pegfilgrastim-cbqv) franchise, including the UDENYCA pre-filled syringe, the UDENYCA autoinjector, and UDENYCA ONBODY®. The company is also marketing HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), and CAMCEVI® (leuprolide) 42 mg injectable emulsion. Please refer to the Important Safety Information and full Prescribing Information for all products. Intas Pharmaceuticals, Ltd. has an exclusive agreement with Bio-Thera Solutions to enable Accord BioPharma to bring Bio-Thera's golimumab candidate BAT2506 – a biosimilar to Simponi® (golimumab) – to the U.S. market, further expanding Accord BioPharma's pipeline. Accord BioPharma has also submitted Biologics License Applications to the FDA for biosimilar versions of several other biologics. Contact: [email protected] IMPORTANT SAFETY INFORMATION IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA. 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) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . IMULDOSA is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous infusion in 130 mg/26 mL (5 mg/mL) strength. For more information, please see the full Prescribing Information and Medication Guide. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide more 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. Johns Hopkins University, Department of Pathology. Prevalence of Autoimmune Diseases. 2025. 3. Bakshia, N., Hartb, A. , Lee, M., et al. PAIN 2021; 62:2466–2471 4. Armuzzi, A., Liguori, G. Digestive and Liver Disease 2021;53(7):803-808 5. Ponikowska, M., Vellone, E., et al. Psoriasis: Targets and Therapy 2025;15:175–183 All trademarks, logos and brand names are the property of their respective owners. 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

The WINDWARD study is a multinational, double-blind, 3-arm Phase 2 study to evaluate the safety and efficacy of mirivadelgat in adult subjects with PH-ILD. Mirivadelgat is a first-in-class oral small molecule with a novel mechanism of action, having the potential to provide a disease-modifying treatment for patients with PH-ILD, through its effect on both the cardiovascular and interstitial lung disease components of PH-ILD. PH-ILD is an underserved severe disease. Approximately 30% of ILD patients develop PH, with up to 100,000 diagnosed PH-ILD patients in the U.S.1 TAIPEI, May 15, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced the dosing of the first patient in the Phase 2 pulmonary hypertension-associated interstitial lung disease (PH-ILD) study (WINDWARD study). The WINDWARD study is a Phase 2, multinational, double-blind, 3-arm study to evaluate the safety and efficacy of mirivadelgat (FP-045), an oral aldehyde dehydrogenase 2 activator, in adult subjects (aged 18 to 85 years) with PH-ILD. The WINDWARD Phase 2 study is designed for 16-weeks to evaluate the safety and efficacy of mirivadelgat administered orally compared to placebo in 99 patients (33 evaluable subjects in each cohort) with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The primary endpoint will be the mean change from baseline to week-12 in the Pulmonary Vascular Resistance (PVR) assessed by right heart catheterization for mirivadelgat versus placebo in subjects with PH-ILD. Multiple secondary endpoints will be included, such as the mean change from baseline to week-12 of long-term prognostic risk factors, e.g., N-terminal pro-brain natriuretic peptide (NT-ProBNP) in subjects with PH-ILD and the mean change from baseline to week-12 of the 6-minute walk distance in subjects with PH-ILD. "Dosing of the first patient in the WINDWARD study is a testament to the dedication of our team to finding a potential therapy for patients with PH-ILD. This trial builds on rigorous foundations and incorporates a robust design to evaluate mirivadelgat 's safety and efficacy across several clinical endpoints, including improvements in Peripheral Vascular Resistance (PVR) and functional capacities in PH-ILD patients. We are committed to executing this study efficiently, generating high-quality evidence, and ensuring patient safety to advance mirivadelgat as a transformative option for patients with Pulmonary Hypertension associated Interstitial Lung Disease (PH-ILD)." Stated Bassem Elmankabadi, M.D., Senior Vice President, Clinical Development. "Mirivadelgat (FP-045) is a scientific breakthrough mechanism targeting ALDH2 activation. Preclinical data demonstrated mirivadelgat's disease modifying activity on lung fibrosis, heart hypertrophy, and fibrosis as well as pulmonary and cardiac function. The WINDWARD trial will validate its clinical impact, potentially ushering in a new treatment era for patients with limited options. This milestone underscores our leadership in leveraging cutting-edge science to improve lives." Stated Dr. Wenjin Yang, Ph.D., Chief Scientific Officer. Dr. Ben Chien, Ph.D., Chairman and CEO of Foresee Pharmaceuticals, stated: "Today's achievement reflects Foresee's unwavering mission to pioneer life-changing therapies. The initiation of Phase 2 for mirivadelgat is a strategic milestone that brings us closer to delivering hope to millions affected by the PH-ILD condition. We thank the investigators, patients, and our talented team for their relentless pursuit of innovation." About PH-ILD Pulmonary hypertension (PH) leads to abnormally high mean pulmonary arterial pressure (mPAP), and it is a complex and devastating disease that causes progressive vasoconstriction and vascular remodeling of the distal pulmonary arteries. A significant proportion of patients with Interstitial Lung Disease (ILD), a group of severe, progressive lung disorders that can damage the lungs and make it harder to breathe, such as Idiopathic pulmonary fibrosis (IPF), pulmonary fibrosis (PF), combined pulmonary fibrosis and emphysema (CPFE), and connective tissue disease (CTD) will develop PH as a result of their arteries in the lungs tightening so that blood can only go to areas of the lungs that are receiving the most air and oxygen. This tightening leads to high blood pressure throughout the lungs. The only approved treatment for PH-ILD is inhaled treprostinil. About Mirivadelgat Foresee is positioning mirivadelgat, as a first-in-class, once-a-day oral drug for the treatment of PH-ILD and other rare/severe diseases. Mirivadelgat and other Foresee oral ALDH2 activators have demonstrated compelling non-clinical efficacy across a broad panel of animal pharmacology and translational models, highlighting the pivotal role of ALDH2 activation in the modulation of mitochondrial stress, energetics, tissue inflammation, fibrosis, and muscle function, amongst some of its key functions. The efficacy observed in models of heart failure, pulmonary hypertension, muscle dysfuntion and pulmonary fibrosis/interstitial lung disease, is highly impressive, demonstrating disease modifying efficacy on lung fibrosis, heart hypertrophy and fibrosis as well as pulmonary and cardiac function. The body of data strongly supports the ongoing Phase 2 WINDWARD study. About Foresee Pharmaceuticals Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets, and secondly, its transformative preclinical and clinical first-in-class oral NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and launched in the U.S. and Germany. The China MAA of CAMCEVI 6-month was accepted for a substantive review. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, and the EU regulatory submission for the 3-month version of CAMCEVI has been completed in March 2025, and accepted for scientific assessment. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients has been initiated. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED