The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for tofacitinib (Xeljanz 5 mg), eliminating the Risk Evaluation and Mitigation Strategy (REMS) requirement that was initially approved on Nov. 6, 2012, and modified on June 19, 2015.1 The REMS consisted of a communication plan and a timetable for submission of REMS assessments.
CHS-0214 Shows Biosimilarity to Etanercept
CHS-0214, a proposed etanercept (Enbrel) biosimilar, met its primary endpoint of ACR20 at Week 24 in a Phase 3 clinical trial.2 In this study, CHS-0214 was compared with the safety and efficacy of etanercept in patients with moderate to severe rheumatoid arthritis (RA) that was inadequately controlled with methotrexate (MTX) monotherapy.
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Compared with etanercept, CHS-0214 had no clinically meaningful differences in safety and immunogenicity. This current study will continue for 52 weeks. It’s the second Phase 3 trial of CHS-0214, which is manufactured by Baxalta.
In November 2015, CHS-0214 met its primary endpoints for the treatment of patients with chronic plaque psoriasis.
Adalimumab Biosimilar Accepted for FDA Review
The FDA has assigned a decision due date of Sept. 25, 2016, for evaluating the biologics license application (BLA) for ABP-501, Amgen’s adalimumab (Humira) biosimilar.3 Submitted in 2015, patients with moderate to severe RA and moderate to severe plaque psoriasis met primary safety and clinical efficacy endpoints. ABP-501 showed no clinically meaningful differences to adalimumab in Phase 3 clinical trials.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Han DH. Xeljanz released from REMS requirement. MPR. 2016 Feb 10.
- Anekwe L. Baxalta’s Enbrel biosimilar measures up in late-stage study. Pharmafile.com. 2016 Jan 13.
- Levy J. FDA to review Amgen’s Humira biosimilar. Pharmafile.com. 2016 Jan 16.