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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.
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.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
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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.
The Top 5 Most-Read Ophthalmology Articles of 2024
December 30th 2024The 2024 surge in FDA approvals for aflibercept biosimilars reflects significant progress in offering cost-effective treatments for retinal conditions like neovascular age-related macular degeneration, although patent disputes pose challenges to their market entry and adoption.
Top 5 Most-Read Rheumatology Articles of 2024
December 30th 2024The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.
