Purple Book reference family · 351(a) biologic
pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)
pembrolizumab and berahyaluronidase alfa-pmph is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
351(a) biologicBLA 761467 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761467
Keytruda Qlex pembrolizumab and berahyaluronidase alfa-pmph
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference pembrolizumab and berahyaluronidase alfa-pmph product.
10 mo ago
pembrolizumab and berahyaluronidase alfa-pmph: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for pembrolizumab and berahyaluronidase alfa-pmph.
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