J&J's Once-Monthly Simponi Approved for Three Rheumatic Indications
Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
Simponi, which is injected subcutaneously, is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy used only once a month. Other TNF drugs, such as Enbrel, marketed by Wyeth and Amgen, and Abbott Laboratories’ Humira, are generally injected once every week or two weeks. The drug is available in two dosage forms, a prefilled syringe and an autoinjector designed to meet the needs of arthritis patients.
Simponi is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.
The drug will be co-marketed by Centocor and Schering-Plough. Centocor, which developed the drug, will handle US sales, and Schering-Plough will market the drug in most countries outside the US. The drug is a follow-up to Remicade, which also co-marketed by the two companies.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Beyond SaaS: How Service-as-a-Software and Agentic AI Are Powering Labs of the Future
July 18th 2025Globally, scientific labs generate unprecedented volumes of data through cloud-based platforms, yet most of this valuable information remains fragmented and buried across different systems. While traditional software-as-a-service (SaaS) solutions have addressed the accessibility problem, labs still struggle with data overload, forcing scientists to spend countless hours searching for information that should be readily available. This whitepaper presents AI-powered SaaS, the next advancement in lab informatics that is transforming how lab workers interact with their data, enabling natural language conversations that deliver contextualized insights exactly when needed.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
