Full label approval given by FDA for eye disease drug, CIMERLI

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Age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases can now be treated after the U.S. Food and Drug Administration (FDA) approved a biosimilar product interchangeable with an injection.

The approval of CIMERLI (ranibizumab-eqrn) interchangeable with Lucentis, a ranibizumab injection was jointly announced by Polpharma Biologics BV, Formycon AG and Bioeq AG today (August 3).

Joint venture

FYB201 was developed by Bioeq, a joint venture between Polpharma Biologics and Formycon.

At the end of 2019, Coherus BioSciences, Inc. entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI in the US.

The companies said CIMERLI obtained approval from the FDA for the treatment of nAMD and other serious retinal diseases including diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

Retinal diseases

They said 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.

FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. The efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI were found to be comparable to the reference drug Lucentis in patients with nAMD.

Stefan Glombitza, CEO of Formycon AG, 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. 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.” 

Peer-reviewed journal

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

CIMERLI belongs to the anti-vascular endothelial growth factor (VEGF) therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits VEGF, which is responsible for the excessive formation of blood vessels in the retina. The commercial launch of CIMERLI in the US by Coherus, is planned for early October in both 0.3mg and 0.5mg doses.

AMD is the leading cause of vision loss in adults aged over 60 years old in the U.S., and advanced age-related AMD is the world’s leading cause of irreversible blindness. As many as 11 million people in the US are living with a form of age-related AMD, a number which is expected to double to nearly 22 million by 2050. 

Due to a projected increase in the incidence of diabetes across the U.S. over the next two decades, the burden of diabetic-related eye diseases, like DME and DR, are also likely to rise.  As the prevalence of serious retinal diseases increases, so do the costs of treating these diseases. The estimated global cost of visual impairment from AMD is more than $300 billion, including more than $250 billion in direct health care costs.

Advanced biosimilars

“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 added.

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