Formycon and Bioeq Confirms BLA Submission Strategy and Timeline for FYB201 (biosimilar, ranibizumab)

Shots:

• The companies confirm the planned timeline for resubmission of the BLA for FYB201 following a successful pre-BLA interaction with the US FDA
• In Nov’2020, the initial submission strategy of FYB201 (biosimilar referencing Lucentis) has been adjusted as part of a simplification of the approval procedure
• The BLA-submission is expected to be filed with the US FDA in H1’21 while the submission to the EMA is expected to follow-up. Additionally, the companies are seeking approval for FYB201 in Canada, Australia, the UK and Switzerland

Click here to­ read full press release/ article | Ref: Formycon | Image: Formycon