Jun 09, 2026
MoonLake Immunotherapeutics plans to submit an FDA Biologics License Application for Sonelokimab in hidradenitis suppurativa by the end of September following a positive pre-BLA meeting. The submission is supported by clinical trial data showing 43% of patients achieved high-level improvement by Week 12 in the Mira trial. The company is also expecting multiple Phase 3 data readouts throughout the year.
Jun 06, 2026
Recent research highlights advances in precision medicine for psoriatic arthritis, including a biopsy-driven treatment strategy that improved clinical outcomes and ongoing investigation into new biologic agents, combinations, and biomarker panels.
May 05, 2026
Johnson & Johnson said Tremfya met the primary endpoint in the Phase 3 FUZION study in active perianal fistulizing Crohn’s disease. At Week 24, both Tremfya dosing regimens showed statistically significant combined fistula remission versus placebo.
Apr 09, 2026
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
Mar 23, 2026
Bio-Thera Solutions expands its partnership with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, through an exclusive commercialization agreement for India. The India biosimilars market is projected to grow from $184 million to $1.02 billion by 2035, driven by patent expirations and strategic partnerships.
Mar 14, 2026
AbbVie reported Q4 earnings that beat consensus estimates with $16.62 billion in revenue, while facing competitive setbacks in psoriatic arthritis and Medicare pricing challenges for Botox.
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The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million.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.
Feb 21, 2026
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
Feb 23, 2026
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
Feb 21, 2026
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
Feb 21, 2026
Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar application targeting Bristol-Myers Squibb's Orencia, marking the first U.S. application for an off-patent version of the arthritis treatment that generated $2.7 billion in 2025.
Feb 18, 2026
Phase 3b TOGETHER-PsO trial shows concomitant use of ixekizumab and tirzepatide delivered superior skin clearance and weight loss versus monotherapy in adults with moderate-to-severe plaque psoriasis and obesity or overweight.
Dec 19, 2025
Takeda announced positive Phase 3 results for zasocitinib in adults with moderate-to-severe plaque psoriasis, meeting all 44 endpoints. The company is also conducting a Phase 3 trial in pediatric patients.
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.
Feb 13, 2026
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
