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The Birth Of An Orphan Biosimilar Market

 
• By Paul Zhang, Triona Bolger, Varun Renjen, Brian Sattin, Anny Lin, and Aditya Venugopal

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.

Biosimilars have attracted great interest from traditional biologics powerhouses and start-ups alike as a large estate of patents is expiring and clear regulatory pathways are emerging across major markets. Unsurprisingly, the first salvo of the modern era "biosimilar" is aimed at blockbusters, such as Abbvie Inc.'s Humira (adalimumab) and Genentech Inc.'s Rituxan (rituximab), based upon their aging patent lives and lucrative commercial potential; many more oncology and auto-immune biologics will soon face a similar fate.

Biosimilar versions of orphan biologics, on the other hand, have not been earnestly pursued yet, even though biologics comprised 67.5%...

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