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Orphan Biosimilars: Developers See Big Prospects In Small Markets; Soliris Is One Target

 
• By Kate Rawson

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.

The initial market for biosimilars has centered on large-market opportunities like Genentech’s Rituxan and AbbVie’s Humira. But behind that first wave are unique opportunities in much smaller markets – with some companies already eyeing pure-play orphan biosimilars to treat rare diseases.

Given the biosimilars market is still in a prolonged early phase (especially in the US), it may seem premature to...

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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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More from Biosimilars & Generics

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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