Alvotech Plant Faces FDA Setback on Simponi Biosimilar
Patients seeking a more affordable alternative to Johnson & Johnson’s anti-inflammatory drug Simponi may face delays. An FDA inspection this summer disrupted the approval process for a biosimilar developed by partners Teva and Alvotech.
FDA's Complete Response Letter
The FDA issued Alvotech a complete response letter (CRL) concerning their candidate, known as AVT05. This decision affects the company's application for both prefilled syringe and autoinjector versions of the Simponi biosimilar, whose generic name is golimumab.
The FDA highlighted "certain deficiencies" found during a July inspection of Alvotech’s manufacturing plant in Reykjavik, Iceland.
Alvotech stated in November that these manufacturing-related issues must be addressed before the FDA can grant approval for AVT05.
Impact on Patients and Partners
- The delay pushes back availability of a lower-cost Simponi alternative.
- Teva and Alvotech must resolve plant issues for regulatory clearance.
Summary
Alvotech’s manufacturing shortcomings identified by the FDA have stalled approval of their Simponi biosimilar, delaying a cost-effective option for patients.