Cimerli (ranibizumab-eqrn)

aBL 761165

Cimerli (ranibizumab-eqrn)

aBL 761165

U.S. License Holder:

Coherus Biosciences / Bioeq

Date of License:

August-02-2022 (Interchangeable)

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

CIMERLI (ranibizumab-eqrn), a vascular endothelial growth factor (VEGF) inhibitor, is 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);

Myopic Choroidal Neovascularization (mCNV).

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Ranopto® (Bioeq / Teva) (December-2023)

Biosimilars Approved In The E.U.

Ongavia (Teva / Bioeq) (May-2022 in the United Kingdom)
Ranivisio (Teva / Bioeq) (August-2022)

Related News

Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf)
Robert S. Schwartz, Ph.D.
May 3, 2024
The State of Biosimilars in 2023
April Breyer Menon Ha Kung Wong
March 17, 2023
Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar Interchangeability
April Breyer Menon Ha Kung Wong
November 30, 2022
Venable’s BiologicsHQ Monthly Injection – October 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
November 14, 2022
Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 11, 2022
Venable’s BiologicsHQ Monthly Injection – August 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 8, 2022
First Interchangeable FDA Approval without a Switching Study
April Breyer Menon Ha Kung Wong
August 31, 2022

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