FDA Approves Ranibizumab-eqrn Biosimilar, Interchangeable with Lucentis

Officials with the FDA have approved FYB201 (Cimerli; Polpharma Biologics), or ranibizumab-eqrn, as the first and only biosimilar interchangeable with Lucentis.

FYB201 is an anti-vascular endothelial growth factor (VEGF) therapy, which is a class of biologics that have significantly helped retinal patients maintain or regain vision. The treatment inhibits VEGF, which is responsible for the excessive formation of blood vessels in the retina.

The biosimilar obtained approval for the treatment of age-related neovascular macular degeneration as well as other serious retinal diseases, such as diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. These approvals make ranibizumab-eqrn the only biosimilar approved for all 5 Lucentis indications.

“We are very delighted about the full label approval as it will allow [us] to offer this highly effective treatment option to an increasing number of patients with retinal diseases,” Stefan Glombitza, CEO of Formycon AG, said in a press release.

The biosimilar was developed by Bioeq, which is a joint venture between Polpharma Biologics and Formycon. In 2019, Coherus BioSciences, Inc, entered into a license agreement for exclusive commercialization under the brand name Cimerli. Commercial launch is expected in October 2022, with 0.3 mg and 0.5 mg dosages.

The FDA approval and interchangeability designation are based on a totality of evidence, including analytics, nonclinical, clinical, and manufacturing data. The efficacy, safety, pharmacokinetics, and immunogenicity of FYB201 were found to be comparable to Lucentis in patients with age-related neovascular macular degeneration.

Age-related neovascular macular degeneration is the leading cause of vision loss among adults 60 years of age or older in the United States, and advanced age-related disease is the world’s leading cause of irreversible blindness. According to the press release, as many as 11 million people in the United States are living with a form of age-related macular degeneration, which is expected to double to nearly 22 million by 2050. Rates of diabetic-related eye diseases are also likely to rise due to a projected increase in the incidence of diabetes across the United States in the next 2 decades.

Importantly, as the prevalence of serious retinal diseases increases, the costs of treating these diseases is also growing, according to the press release. The estimated global cost of visual impairment from age-related macular degeneration is more than $300 billion, including more than $250 billion in direct health care costs.

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

Reference

US Food and Drug Administration (FDA) Approves FYB201/Cimerli (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis. News release. Polpharma Biologics; August 3, 2022. Accessed August 3, 2022. https://polpharma-test.bisons.dev/en/knowledge/latest-news/article/u-s-food-and-drug-administration-fda-approves-fyb201-cimerlitm-ranibizumab-eqrn-the-first-and-only-biosimilar-interchangeable-with-lucentis-r