Weekly Top News – IBD – March 30, 2020

AVT02 (adalimumab biosimilar) / Alvotech, CiplaAlvotech and DKSH partner on adalimumab in Asia (Generics Bulletin - Informa) - Mar 26, 2020 - "Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020."

ozanimod (RPC1063) / BMSInduction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Mar 25, 2020 - P3; N=675; Recruiting; Sponsor: Celgene; Trial primary completion date: Feb 2020 --> Mar 2022

Humira (adalimumab) / Eisai, AbbVieObservational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA ) (clinicaltrials.gov) - Mar 26, 2020 - P=N/A; N=98; Completed; Sponsor: AbbVie; Active, not recruiting --> Completed

ozanimod (RPC1063) / BMSA Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Mar 25, 2020 - P3; N=535; Recruiting; Sponsor: Celgene; Trial primary completion date: Apr 2021 --> Mar 2023

ozanimod (RPC1063) / BMSAn Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Mar 25, 2020 - P3; N=1040; Recruiting; Sponsor: Celgene; Trial completion date: Oct 2024 --> Jun 2024; Trial primary completion date: Dec 2022 --> Mar 2024

ozanimod (RPC1063) / BMSInduction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - Mar 25, 2020 - P3; N=675; Recruiting; Sponsor: Celgene; Trial completion date: Mar 2022 --> Jun 2022; Trial primary completion date: Mar 2020 --> Mar 2022

filgotinib (GLPG0634) / GileadGalapagos CEO talks next steps as coronavirus stalls the biotech's top drug (BioPharma Dive) - Mar 25, 2020 - "As the companies await the agency's decision, they're investigating filgotinib across other immune-related diseases. A federal database of clinical trials shows 14 ongoing studies testing the drug in Crohn's disease, ulcerative colitis and psoriatic arthritis, among other conditions....The new coronavirus, however, has prompted Gilead and Galapagos to pause enrollment for more than half of these trials."