July 8, 2023

Complete Response Letter for AVT 02 biosimilar candidate for Humira – Alvotech

Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira (adalimumab). As the second of two BLAs submitted for AVT 02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation. The CRL […]

admin Health 0 51 sec read
October 12, 2021

Two studies of Remsima SC shows switching to subcutaneous therapy has no impact on treatment for inflammatory bowel disease – Celltrion Healthcare

Celltrion Healthcare announced two data sets relating to the use of the subcutaneous formulation of infliximab, Remsima SC (CT-P13 SC), in inflammatory bowel disease (IBD). The first study investigated clinical impact of switching from intravenous (IV) to subcutaneous (SC) treatment of infliximab in patients with Crohn’s disease (CD) or ulcerative colitis (UC) from the pivotal randomised controlled trial of CT-P13 […]

admin Health 0 1 min read

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