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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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