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FDA approves Bioeq’s Lucentis biosimilar

​​​​​​​Cimerli is the only biosimilar approved for all five Lucentis indications.

The Food and Drug Administration has approved Cimerli (ranibizumab-eqrn), a biosimilar product interchangeable with Genentech’s Lucentis (ranibizumab injection), that was developed by Bioeq, a joint venture between Polpharma Biologics and Formycon.

At the end of 2019, Coherus BioSciences entered into a license agreement for the exclusive commercialization of FYB201 under the brand name Cimerli in the United States.

Cimerli obtained approval from the FDA for the treatment of age-related neovascular (wet) macular degeneration and other serious retinal diseases, such as diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

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Cimerli is the first and only interchangeable biosimilar with an exclusivity for 12 months after market launch that is indicated for the treatment of all five Lucentis indications and, as such, is a new medical option for patients with serious retinal diseases.

Cimerli belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits vascular endothelial growth factor, which is responsible for the excessive formation of blood vessels in the retina.

The commercial launch of Cimerli in the United States by Coherus is planned for early October in both 0.3 mg and 0.5 mg doses.

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“As the impact of serious retinal diseases continues to rise in the U.S., it is critical that treatment options are both efficacious and affordable. Advanced biosimilars to Lucentis can change patients’ lives while also minimizing the financial impact of the cost of treatment on healthcare systems,” said Michael Soldan, CEO of Polpharma Biologics Group.

“Polpharma Biologics is proud to have collaborated with Formycon and Bioeq on the development of ranibizumab biosimilar, and we are excited about our contribution to this valuable treatment option that we expect to positively impact many patients lives,” he said.

“We are very delighted about the full label approval as it will allow to offer this highly effective treatment option to an increasing number of patients with retinal diseases,” said Stefan Glombitza, CEO of Formycon AG. “At the same time, we would like to thank our partners Bioeq and Polpharma Biologics for the excellent joint development work and are pleased that Coherus acts as commercialization partner for the U.S.”




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