trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)
trastuzumab and hyaluronidase-oysk is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Herceptin Hylecta trastuzumab and hyaluronidase-oysk
Genentech, Inc.
- Approved
- Feb 28, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for trastuzumab and hyaluronidase-oysk, in chronological order.
Reference approval
Approval date of the reference trastuzumab and hyaluronidase-oysk product.
7 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)?
No 351(k) biosimilars or interchangeable biosimilars referencing trastuzumab and hyaluronidase-oysk 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.