Tags : Plaque Psoriasis

Biosimilars

Henlius Present Results of HLX03 (biosimilar, adalimumab) in P-lll Study

Shots: The P-III HLX03-Ps03 study involves comparing the efficacy, safety and immunogenicity assessing of HLX03 (80mg, qd) with reference adalimumab in 262 Chinese patients in the ratio of (1:1) with moderate to severe plaque psoriasis Result: On 1EPs % improvement of PASIwk16 (83.48% vs 82.02%), least square mean difference (1.46%), no significant differences between the […]Read More

Regulatory

UCB Reports the FDA’s and EMA’s Acceptance of BLA and

Shots: The marketing application submissions are based on three P-III studies- BE VIVID, BE READY, BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO All 3 P-III studies met their 1EPs, demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured […]Read More

Regulatory

Amgen Receives Health Canada’s Marketing Authorization Transfer of Otezla for

Shots: Health Canada’s marketing authorization transfer of Otezla from Celgene follows Amgen’s acquisition of the global rights of Otezla completed in Nov’2019 The addition of Otezla bolster Amgen’s portfolio of innovative biologics and biosimilar products and complements its expertise in mod. to sev. PsO and active PsA Otezla is a selective PDE4 inhibitor, inhibiting the […]Read More