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Extra Indications Approved For Celltrion’s Remsima SC

Subcutaneous Biosimilar Infliximab Also Helps Minimize COVID-19 Risk

Executive Summary

The European Commission has granted an extension to Celltrion’s pan-European marketing authorization for subcutaneous biosimilar infliximab, which now covers indications for IBD and ankylosing spondylitis.

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Celltrion Calls For Harmonized Approach To ‘Biobetters’

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.

Hikma Adds Remsima SC To Celltrion MENA Collaboration

Hikma has added Celltrion’s Remsima SC subcutaneous formulation of biosimilar infliximab to a marketing alliance in the MENA region that already includes three other Celltrion biosimilars.

Celltrion’s Kim Emphasizes Innovation As Pipeline Grows

Celltrion will adopt a “next generation” innovative approach to developing biosimilars as it continues to bolster its pipeline, HoUng Kim, head of Celltrion Healthcare’s medical and marketing division, tells Generics Bulletin in an exclusive interview. But the firm sees the US interchangeability designation as an “unnecessary” regulatory barrier.

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