FDA Approves Lynparza (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment ofAdult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
June 1, 2023
Recalls: Adverse events can be reported to the FDA’s MedWatch program.
June 1, 2023
June 1, 2023 - Coherus BioSciences announced plans to launch Yusimry its Humira biosimilar, Yusimry (adalimumab-aqvh) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
- The expected launch date for Yusimry is July 2023.
- Yusimry is a biosimilar to Humira and does not have an interchangeability designation.
- Yusimry is a citrate free formulation approved in the following dosage forms:
- Single-dose prefilled pen (Yusimry Pen): 40 mg/0.8mL
- Single-dose prefilled glass syringe: 40 mg/0.8 mL
- Yusimry is administered via subcutaneous injection.
- The FDA approval of Yusimry is based on clinical data that demonstrates Yusimry is biosimilar to Humira.