Orphan Biosimilars: Developers See Big Prospects In Small Markets; Soliris Is One Target
Using lessons learned from the first wave of biosimilar approvals – and citing high prices in the US – some developers are starting to 'think small' with biosimilars for rare disease markets. Alexion’s Soliris is a case in point.
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Hard-won experience from the first wave of broad-market biosimilars will inform development of "orphan biosimilars," but Navigant Consulting says that biopharmas entering this orphan market will face a unique set of challenges.
China-Only Studies Are ‘Problematic,’ US FDA’s Pazdur Says Ahead Of Lilly/Innovent PD-1 Inhibitor Review
February advisory committee for sintilimab expected to address three main questions about applications relying on single-country data.
Instead of waiting until after regulatory events like COVID boosters and Aduhelm, FDA should describe its decision-making process along the way to help restore public faith in the agency, former deputy commissioner Josh Sharfstein says.