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Innovent Biologics Gains NMPA Approval for Additional Sulinno Indications
China's National Medical Products Administration (NMPA) has cleared Innovent Biologics' adalimumab biosimilar for more indications.
China’s National Medical Products Administration (NMPA) has approved Innovent Biologics’ adalimumab injection biosimilar (Sulinno) for new indications: pediatric plaque psoriasis and noninfectious intermediate uveitis, posterior uveitis, and panuveitis in adults for whom corticosteroid therapy may be inappropriate or ineffective.
Sulinno was previously approved by the NMPA for rheumatoid arthritis, ankylosing spondylitis, psoriasis and polyarticular juvenile idiopathic arthritis. Those approvals were issued in September 2020.
"There remains huge unmet medical need for the treatment of psoriasis and uveitis in China,” Qian Lei, senior director of Medical Sciences and Strategies of Special Diseases for Innovent, said in a statement, explaining the value of this medicine.
Psoriasis is a skin disease characterized by accelerated growth of skin surface cells, resulting in pain and psychological burden. Uveitis is a type of eye inflammation that can increase risk for glaucoma, macular edema, and cataracts.
FDA, EMA Approve Second Pair of Denosumab Biosimilars
February 17th 2025The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Disease Activity, Safety Remain Following Switch From Infliximab Biosimilar to Remicade in IBD
February 15th 2025Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
