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.
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.
Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.