Drug Approval | July 24, 2024
Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
The transfer of the distribution rights will strengthen Sandoz's immunology and biosimilar portfolio
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
The SELECT-SWITCH study, first head-to-head Phase 3b/4 trial, compared switching to Rinvoq versus switching to another TNF inhibitor
Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
The approval marks a significant milestone for the American pharmaceutical company in the field of UC
The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone
Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris
Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries
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