Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant (Cervarix)
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2009
Reference approved
Reference product
Cervarix Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
GlaxoSmithKline Biologicals
- Approved
- Oct 16, 2009
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, in chronological order.
Reference approval
Approval date of the reference Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant product.
16 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant (Cervarix)?
No 351(k) biosimilars or interchangeable biosimilars referencing Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant are listed in the FDA Purple Book yet.
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