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Celltrion Plans EU Filing For Remsima SC As Phase III Completed

Executive Summary

Celltrion is preparing to make a filing in the second half for the regulatory approval in the EU of a subcutaneous version of its infliximab biosimilar Remsima, the first biosimilar with a changed formulation, in an effort to diversify its portfolio and boost the product's market competitiveness.

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Intensifying competition in the global biosimilars space and a temporary drop in its factory utilization rate took a toll on Celltrion's earnings in the third quarter, but analysts still expect a rosy outlook next year amid the expected US launches of biosimilar rituximab and trastuzumab, and the first subcutaneous version of Remsima on the horizon in Europe.

Celltrion Hit By Truxima Price Cut, Temporary Utilization Rate Drop

Intensifying competition in the global biosimilars space and a temporary drop in its factory utilization rate took a toll on Celltrion's earnings in the third quarter, but analysts still expect a rosy outlook next year amid the expected US launches of biosimilar rituximab and trastuzumab, and the first subcutaneous version of Remsima on the horizon in Europe.

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