Interchangeable biosimilars to Prolia and Xgeva target osteoporosis and cancer-related bone complications in a $5 billion U.S. market
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility
Samsung Biologics will continue supplying products previously manufactured at the site to GSK
Company leadership is framing the move as transformational.
The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy
Its a major breakthrough for women’s ovarian cancer care in Europe
The trial, dubbed MALBEC, marks the first in a broader late-phase development push for MK-8748, with a second NVAMD study expected to begin later this year
A joint position paper warns that Europe is the only major global region without a dedicated biomanufacturing initiative
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