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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In this month’s stock column, after the Nasdaq Biotech Index (NBI) shot up over 10% at end of June, Scrip focuses on the biopharma companies that propelled that surge. It looks as if investors have been influenced by the BIO Convention held in San Diego, the industry’s biggest forum for self-promotion.
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.
Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows
Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.