The indication approved by the MHRA is use in adults for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularisation. It will be available as a 10 mg/ml solution for injection, and each vial contains 2.3 mg of ranibizumab in 0.23mL solution .
MHRA grants MA for FYB201. Teva will market the biosimilar under name Ongavia throughout the UK 
FDA accepts BLA for review with a target action date of August 2022 
Bioeq has positive pre-BLA filing meeting with US FDA .
Formycon and Bioeq announce that marketing authorization application (MAA) for FYB201 has been submitted to the European Medicines Agency .
Formycon plans to re-file its BLA-submission with the FDA in H1 2021. Submission to the EMA is expected to follow .
Formycon and Bioeq announce their intention to obtain regulatory approval for ranibizumab biosimilar in Canada, Australia, the UK and Switzerland .
Coherus Bioseciences has conducted a pre-BLA meeting with the US FDA for the planned submission of a BLA. It plans to launch in the US in 2023 if approved .
Bioeq holds the exclusive global marketing rights for the product, and is actively seeking partners to out-license the drug. In Nov 19, Bioeq entered into an agreement with Coherus for the marketing and distribution of ranibizumab biosimilar in the US .
In its latest half-year report, Formycon reports that its development activities in the second half of 2020 will focus on preparations for submission to the EMA and re-submission to the FDA .
FDA requests additional data as the contract manufacturer of the active ingredient of FYB201 had moved part of the process equipment to another part of its site after batches of FYB201 for process qualification had already been produced. FDA has asked for additional data from the new production environment. As Formycon estimates this will take at least 4 months they have withdrawn the licence application and will resubmit after incorporating the new data .
Filed in the US by licence partner Bioeq AG .
Bioeq aims to file a license application with the Food and Drug Administration (FDA) before the end of 2019 and Coherus plans to launch the product on the US market in 2021 .
Development going ahead in US in collaboration with Bioeq, who will distribute and market FYB201 .