Related coverage linked through entity extraction aliases.
May 05, 2026
Risankizumab data in Crohn’s disease showed 55% clinical remission at week 12 in AFFIRM, durable efficacy through 148 weeks in SEQUENCE, and the lowest 24-month switch rate in a U.S. claims analysis.
Apr 29, 2026
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Apr 25, 2026
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
Mar 24, 2026
The FDA has eased biosimilar approval procedures as these therapies have generated $56 billion in savings since 2015. New guidance eliminates comparative efficacy studies, potentially saving manufacturers $100 million per product and cutting development time by 50%. Despite growth to 23% of the biologics market, a "biosimilar void" threatens $232 billion in missed savings over the next decade.
Mar 11, 2026
The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
Mar 05, 2026
Protagonist Therapeutics reported fourth quarter and full year 2025 financial results, with two NDAs submitted and multiple Phase 3 trials advancing. The company holds $646 million in cash and expects regulatory decisions in 2026.
Mar 02, 2026
AbbVie announced positive topline results from the Phase 3 AFFIRM study showing risankizumab subcutaneous induction achieved superior clinical remission and endoscopic response rates versus placebo in adults with moderately to severely active Crohn's disease.
Feb 21, 2026
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
Feb 13, 2026
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
Feb 13, 2026
The European Commission has approved Gotenfia (golimumab), a biosimilar to Simponi developed by Bio-Thera and marketed by STADA, for chronic inflammatory autoimmune diseases across the EU and EEA.
