Pyzchiva® — Venable's BiologicsHQ

U.S. License Holder:

Samsung Bioepis / Sandoz

Date of License:

June-28-2024 (Interchangeable)

Last Update:

Nov-15-2024

FDA-Approved Indications

PYZCHIVA (ustekinumab-ttwe) is a human interleukin -12 and -23 antagonist indicated for the treatment of:

Adult patients with:

Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy;

Active psoriatic arthritis (PsA);

Moderately to severely active Crohn's disease (CD);

Moderately to severely active ulcerative colitis.

Pediatric patients 6 years and older with:

Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy;

Active psoriatic arthritis (PsA).

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Eksunbi (Samsung Bioepis) (September-2024)
Pyzchiva® (Sandoz / Samsung Bioepis) (April-2024)

Biosimilars Approved In South Korea

Epyztek (Samsung Bioepis) (April-2024)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2023-01103

U.S. Patent No.
10,961,307 (Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 102 Challenge
Y: Claims 1-4, 6-22, 24-34

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-34

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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Pyzchiva® (ustekinumab-ttwe)

Pyzchiva® (ustekinumab-ttwe)

FDA-Approved Indications

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Biosimilars Approved In South Korea

Inter Partes Review Proceedings

IPR Case No(s):

IPR2023-01103

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