On 14 August 2024, Celltrion received FDA approval for its global phase 3 clinical trial of CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).
Celltrion reports that global market sales for Cosentyx® reached US $4.98 billion in 2023, and that Novartis’ “material patent” to secukinumab will expire in January 2029 in the US and July 2030 in Europe.
The FDA approved Novartis’ Cosentyx® in October 2023 for moderate to severe hidradenitis suppurativa. Cosentyx® was also approved in June 2023 by EMA for the same indication.
Bio-Thera is also developing a biosimilar to Cosentyx®, BAT2306, and commenced a phase 3 clinical trial in November 2022, which is estimated to be completed in the second half of 2024.