pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)
pembrolizumab and berahyaluronidase alfa-pmph is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. 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
Keytruda Qlex pembrolizumab and berahyaluronidase alfa-pmph
Merck Sharp & Dohme LLC
- Approved
- Sep 19, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pembrolizumab and berahyaluronidase alfa-pmph, in chronological order.
Reference approval
Approval date of the reference pembrolizumab and berahyaluronidase alfa-pmph product.
9 mo ago
Frequently asked questions
Are there biosimilars approved for pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)?
No 351(k) biosimilars or interchangeable biosimilars referencing pembrolizumab and berahyaluronidase alfa-pmph are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.