Shots:
- The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)
- Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems & manufacturing operations
- Under its partnership with Teva, Alvotech is responsible for the development & manufacturing of AVT05 & AVT06, while Teva handles commercialization. AVT03 is partnered with Dr. Reddy’s, which serves as the applicant for the US submission
Ref: Globenewswire | Image: Alvotech | Press Release
Related News: Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand
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