Pavblu (aflibercept-ayyh)

aBL 761298

Pavblu (aflibercept-ayyh)

aBL 761298

U.S. License Holder:

Amgen

Date of License:

August-23-2024

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

PAVBLU (aflibercept-ayyh) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD);

Macular Edema Following Retinal Vein Occlusion (RVO);

Diabetic Macular Edema (DME);

Diabetic Retinopathy (DR).

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:24-cv-00039 (N.D.W. Va.) (transferred from 1:24-cv-00264 (C.D. Cal.)) / MDL 1:24-md-03103 (N.D.W. Va.)

U.S. Patent Nos.
9,222,106 (Enhanced Expression and Stability Regions) 9,254,338 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 9,315,281 (System and Methods for Use in Dispensing Biopharmaceutical Materials) 9,816,110 (CHO Integration Sites and Uses Thereof) 10,130,681 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,415,055 (Enhanced Expression and Stability Regions) 10,464,992 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 10,669,594 (Compositions and Methods for Detecting a Biological Contaminant) 10,828,345 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,888,601 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 10,905,786 (Sterilisation Method) 10,918,754 (Sterilisation Method) 11,066,458 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,084,865 (VEGF Antagonist Formulations Suitable for Intravitreal Administration) 11,104,715 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,160,918 (Medical Device Packaging and Related Methods) 11,253,572 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,306,135 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,472,861 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,505,593 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,535,663 (Methods for Producing Aflibercept in Chemically Defined Media Having Reduced Aflibercept Variants) 11,542,317 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,548,932 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,555,176 (Cell Culture Medium for Eukaryotic Cells) 11,559,564 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,680,930 (Methods and Systems for Chromatography Data Analysis) 11,707,506 (Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders) 11,753,459 (Anti-VEGF Protein Compositions and Methods for Producing the Same) 11,769,597 (Methods of Associating Genetic Variants with a Clinical Outcome in Patients Suffering from Age-Related Macular Degeneration Treated with Anti-VEGF) 11,788,102 (CHO Integration Sites and Uses Thereof) 11,793,926 (Medical Device Packaging and Related Methods)

Plaintiffs
Regeneron Pharmaceuticals, Inc.

Defendants
Amgen, Inc.

Supreme Court Appeal(s)
24-2351

Status
Case Ongoing; Preliminary Injunction Denied, Federal Circuit Appeal (Preliminary Injunction) Pending, Temporary Injunction Pending Appeal Denied

BPCIA
Y

Related News

Spotlight On: Biosimilar Litigations
April Breyer Menon Ha Kung Wong
November 30, 2024
Amgen Launches Pavblu™ as the First EYLEA® Biosimilar in the U.S.
Robert S. Schwartz, Ph.D.
November 14, 2024
Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction
Robert S. Schwartz, Ph.D.
October 24, 2024
Venable’s BiologicsHQ Monthly Injection – September 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
October 11, 2024
Preliminary Injunction Against Amgen’s EYLEA® Biosimilar Pavblu™ Denied
Robert S. Schwartz, Ph.D.
September 25, 2024
Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval
Robert S. Schwartz, Ph.D.
August 28, 2024
Fifth EYLEA® Biosimilar FDA-Approved: Amgen’s Pavblu™ (aflibercept-ayyh)
Robert S. Schwartz, Ph.D.
August 28, 2024

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha