Golimumab

Johnson & Johnson on Tuesday said the FDA authorised a broader label for Simponi (golimumab) to treat children with moderately to severely active ulcerative colitis (UC) weighing at least 15 kg.  This marks only approved UC treatment enabling monthly maintenance dosing for this population and the first paediatric indication for the injectable anti-TNF therapy, which was previously cleared for adults with the same condition. "The approval…represents a meaningful milestone, offering a therapy with well-established efficacy and safety along with subcutaneous dosing, for younger patients where treatment options have historically been limited,” said Chris Gasink, VP of medical affairs, gastroenterology and autoantibody at Johnson & Johnson Innovative Medicine. The regulatory decision was backed by data from the PURSUIT programme, particularly the Phase III open-label PURSUIT 2 trial, wherein 32% of paediatric patients achieved clinical remission at week 6 — the study's primary endpoint. Moreover, 58% achieved a clinical response and 40% showed endoscopic improvement at week 6, with 57% of early remitters maintaining symptom control through week 54. J&J noted that Simponi — available as a prefilled syringe — will be dosed in children on a weight-based schedule, with patients aged 12 and older able to self-inject after proper training. Besides UC, the TNFα inhibitor holds FDA approvals for treating moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis in adults.

Sept. 22, 2025 -- Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. "We look forward to working with Advanz Pharma to increase access for patients and healthcare professionals to golimumab, as the reference biologic Simponi® is an important treatment option for a number of immune-mediated diseases,” said Joseph McClellan, Chief Scientific and Technical Officer for Alvotech. “The positive CHMP opinion for Gobivaz® is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe,” said Nick Warwick, Chief Medical Officer, Advanz Pharma. The CHMP opinion recommends granting of a marketing authorization for Gobivaz® 50 mg/0.5mL and 100mg/mL in a pre-filled syringe and autoinjector, for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adult patients and juvenile idiopathic arthritis across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein. Gobivaz® remains under EMA regulatory review with a final decision by the European Commission pending. Alvotech is responsible for the development and commercial supply of Gobivaz®. Advanz Pharma is responsible for registration and has exclusive rights for commercialization in Europe. In April 2024 Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and Simponi® (golimumab) in patients with moderate to severe rheumatoid arthritis. In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants. AVT05 is a biosimilar candidate for Simponi® (golimumab) and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Sources [1] Simponi product information Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. The content above comes from the network. if any infringement, please contact us to modify.