COVID-19 Vaccine, mRNA (Comirnaty)
COVID-19 Vaccine, mRNA is an FDA-licensed reference biologic from BioNTech Manufacturing GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
Comirnaty COVID-19 Vaccine, mRNA
BioNTech Manufacturing GmbH
- Approved
- Aug 27, 2025
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for COVID-19 Vaccine, mRNA, in chronological order.
Reference approval
Approval date of the reference COVID-19 Vaccine, mRNA product.
9 mo ago
Frequently asked questions
Are there biosimilars approved for COVID-19 Vaccine, mRNA (Comirnaty)?
No 351(k) biosimilars or interchangeable biosimilars referencing COVID-19 Vaccine, mRNA are listed in the FDA Purple Book yet.
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