FDA Approves FYB201/Cimerli Biosimilar to Lucentis

The FDA has approved Cimerli (ranibizumab-eqrn), a biosimilar drug interchangeable with Lucentis (ranibizumab injectable), according to a joint press release from Polpharma Biologics Group, Formycon AG, and Bioeq AG.

FYB201 was created by Bioeq, a joint venture between Polpharma Biologics and Formycon. A license deal for the exclusive commercialization of FYB201 under the trade name Cimerli in the United States was signed by Coherus BioSciences at the end of the year.

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

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.[1]

Analytical, nonclinical, clinical, and manufacturing data are all used to support FDA approval and interchangeability designation. In patients with wet AMD, Cimerli was found to have similar efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Lucentis.

Clinical readouts from the randomized, double-masked, parallel group, multicenter phase 3 study (COLUMBUS AMD) have been published in the peer-reviewed journal, Ophthalmology.[2]

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

“As the impact of serious retinal diseases continues to rise in the US, 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,” Michael Soldan, CEO of Polpharma Biologics Group, said in the news release.

* Cimerli is a trademark of Coherus BioSciences, Inc.
** Lucentis® is a registered trademark of Genentech Inc.

References

1 U.S. Food and Drug Administration (FDA) website. Available from: https://www.fda.gov/ (Accessed August 2022)
2 Science Direct: Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular     Degeneration - ScienceDirect