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Celltrion Calls For Harmonized Approach To ‘Biobetters’

As Latest Data Shows Benefits Of Subcutaneous Infliximab Biosimilar Remsima SC

 
• By Dave Wallace

A standardized, globally-accepted approach to ‘biobetters’ – biosimilars that offer improvements over the original reference drug – is needed to reduce trial duplication and allow products to come to market more quickly, Celltrion tells Generics Bulletin, at the same time as the company published data showing the benefits of its Remsima SC unique subcutaneous formulation of infliximab.

Good Better Road Sign Divergent Arrows
Celltrion has highlighted divergent approaches to biobetters • Source: ferhat ozyurt / Alamy Stock Photo

Celltrion says a standardized, globally-accepted approach to ‘biobetters’ – biosimilars that offer improvements over the original reference biologic – is needed to reduce unnecessary trial duplication and allow biobetter products to come to market more quickly, following mixed experiences internationally with registering its Remsima SC subcutaneous version of biosimilar infliximab.

Remsima SC was based on Remicade, but offered a unique subcutaneous route of administration that meant that it could not be considered in the same way as a regular biosimilar, unlike the

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