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FDA Purple Book · Reference family

ado-trastuzumab emtansine (Kadcyla)

ado-trastuzumab emtansine 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

2013

Reference approved

Reference product

351(a)BLA 125427

Kadcyla ado-trastuzumab emtansine

Genentech, Inc.

Approved
Feb 22, 2013
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for ado-trastuzumab emtansine, in chronological order.

  1. Reference approval

    Approval date of the reference ado-trastuzumab emtansine product.

    13 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for ado-trastuzumab emtansine (Kadcyla)?

No 351(k) biosimilars or interchangeable biosimilars referencing ado-trastuzumab emtansine are listed in the FDA Purple Book yet.

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