Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
The biosimilar Ustekinumab has been developed and manufactured by the company
The biosimilar Ustekinumab has been developed and manufactured by the company
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics
Rymti is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis
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
Safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications1,2
The aim is to provide further insights into patients' lives in the effort to deliver better outcomes for people with psoriatic arthritis (PsA)
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