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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.
Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD
April 3rd 2025The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
