ABP 206 (nivolumab)

ABP 206 Approval Pending

ABP 206 (nivolumab)

ABP 206 Approval Pending

U.S. License Holder:

Amgen

Date of License:

aBLA accepted by FDA on an undisclosed date prior to September-2026

Last Update:

September-15-2026

approved_indications FDA-Approved Indications

ABP 206 (nivolumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2025-00601

U.S. Patent No.
9,856,320 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Amgen Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-22

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted, Discretionarily Denied by PTO Director; Request for Director Review of Decision Denying Institution Denied

IPR2025-00602

U.S. Patent No.
10,174,113 (Treatment of PD-L1-Negative Melanoma Using an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Amgen Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-20

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted, Discretionarily Denied by PTO Director; Request for Director Review of Decision Denying Institution Denied

IPR2025-00603

U.S. Patent No.
11,332,529 (Methods of Treating Colorectal Cancer)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Amgen Inc.

§ 102 Challenge
Y: Claims 1-18

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-18

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Adverse Judgment Due to Disclaimer)

IPR Status
Adverse Judgment Prior to Institution Due to Disclaimer

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:26-cv-01134 (D. Del.)

U.S. Patent Nos.
8,008,449 (Human Monoclonal Antibodies to Programmed Death 1 (PD-1) and Methods for Treating Cancer Using Anti-PD-1 Antibodies Alone or in Combination with Other Immunotherapeutics) 9,856,320 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling) 10,072,082 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling) 12,479,917 (Methods of Treating NSCLC Comprising Administering Platinum Doublet Chemotherapy Followed by an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody) 12,590,153 (Treatment of PD-L1-Negative Melanoma Using an Anti-PD-1 Antibody and an Anti-CTLA-4 Antibody) 12,590,154 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling) 12,624,107 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb & Sons LLC; Ono Pharmaceutical Co., Ltd.

Defendants
Amgen Inc.

Status
Case Ongoing

BPCIA
Y

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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