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FDA Purple Book · Reference family

amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)

amivantamab and hyaluronidase-lpuj is an FDA-licensed reference biologic from Janssen Biotech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2026

Reference approved

Reference product

351(a)BLA 761484

Rybrevant Faspro amivantamab and hyaluronidase-lpuj

Janssen Biotech, Inc.

Approved
Feb 13, 2026
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for amivantamab and hyaluronidase-lpuj, in chronological order.

  1. Reference approval

    Approval date of the reference amivantamab and hyaluronidase-lpuj product.

    4 mo ago

Frequently asked questions

Are there biosimilars approved for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)?

No 351(k) biosimilars or interchangeable biosimilars referencing amivantamab and hyaluronidase-lpuj are listed in the FDA Purple Book yet.

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