Biosimilars company Biocon Biologics Ltd (BBL), a subsidiary of biopharmaceuticals company Biocon Ltd (NSE: BIOCON), on Wednesday announced significant new data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam, focusing on the interchangeability of adalimumab and adalimumab-fkjp, as well as the biosimilarity of Bmab 1200 to ustekinumab in patients with chronic plaque psoriasis.
The first study, titled 'Multiple switching between the biosimilar adalimumab-fkjp low concentration and reference adalimumab high concentration in patients with chronic plaque psoriasis', evaluated pharmacokinetics (PK), efficacy, safety and immunogenicity in patients either receiving continuous adalimumab or undergoing repeated switches between adalimumab and adalimumab-fkjp. Results showed comparable Psoriasis Area and Severity Index (PASI) responses and safety profiles between both groups, affirming PK equivalence and supporting interchangeability. This study aims to meet FDA requirements for designation as "interchangeable."
The second study, 'A Randomized, Double-blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Reference Biologic-Ustekinumab', assessed 384 patients over 52 weeks. At the 28-week mark, Bmab 1200 demonstrated equivalent efficacy and comparable safety to ustekinumab, supporting its biosimilarity.
Biocon Biologics is committed to providing affordable access to high-quality biosimilars, having commercialized eight products across various global markets. The company continues to expand its pipeline, with 12 biosimilar assets under development targeting chronic conditions like diabetes, cancer and autoimmune diseases.
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