Formycon and Bioeq Adjust Submission Strategy for Lucentis Biosimilar

In an update on development of a ranibizumab biosimilar candidate, FYB201, for the treatment of macular degeneration, Formycon said it is hoping the FDA will grant approval for large-scale commercialization of the agent and that the approval process will be simplified.

In February, Formycon and its licensing partner, Bioeq, said the FDA had requested additional information related to a manufacturing change and that it would require resubmission of the application for FYB201. A piece of equipment was shifted to a new location, and the change was unrelated to product quality or other product characteristics, Formycon and Bioeq said.

The processing equipment had been moved based on the request of European health authorities, and because of this, the FDA requested additional manufacturing data to support the biologics license application (BLA). The BLA was withdrawn while these data were generated.

The companies are aiming at the market for the Lucentis reference product. Lucentis is a Roche product and garnered sales of $1.12 billion in the third quarter of 2020, down 14% from the year-ago comparable quarter.

In the update, Formycon and Bioeq said they had adjusted their resubmission strategy for FYB201 and intended to file the application with the FDA sometime in the first half of 2021. They said the delay was not expected to have any effect on timing for the launch for FYB201 in the United States or European Union.

Ranibizumab is used to treat wet age-related macular degeneration, a disease that causes excessive formation of blood vessels in the retina of the eye, resulting in a progressive loss of central vision, severe visual impairment, or blindness.

Ranibizumab is also used in the treatment of diabetic macular edema, diabetic retinopathy, myopic choroidal neovascularization, and macular edema following retinal vein occlusion.