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FDA Purple Book · Reference family

ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo)

ocrelizumab and hyaluronidase-ocsq 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

2024

Reference approved

Reference product

351(a)BLA 761371

Ocrevus Zunovo ocrelizumab and hyaluronidase-ocsq

Genentech, Inc.

Approved
Sep 13, 2024
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for ocrelizumab and hyaluronidase-ocsq, in chronological order.

  1. Reference approval

    Approval date of the reference ocrelizumab and hyaluronidase-ocsq product.

    1 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo)?

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

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