Big Molecule Watch
August 4, 2022

Coherus Announces FDA Approval of CIMERLI (ranibizumab-eqrn)

On August 2, 2022,  Coherus BioSciences, Inc. announced that the FDA approved CIMERLI (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months of exclusivity.  Retina indications for which CIMERL is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV).  According to the press release, the launch of CIMERLI into the $7 billion anti-VEGF ophthalmology market in the United States is planned for early October 2022.

As previously reported, Coherus’ HUMIRA® biosimilar, YUSIMRY, was approved by the FDA in December 2021 and its launch is planned for next year, and its first FDA-approved product, UDENYCA®, was launched in January 2019

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