Submission took place on September 9th and validation by EMA was communicated today. The EMA validation confirms that the application is sufficiently complete to begin a formal review process. The Company anticipates an EMA review for the biosimilar candidate, which was developed under the Xlucane™ name, will be according to standard timelines.
Xlucane™ is a biosimilar candidate to Lucentis® (ranibizumab), a VEGF-a inhibitor used in treatment of serious eye diseases, mainly wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
A trade name under which the biosimilar, if approved, will be marketed will be announced later in regulatory review process.
“This marks yet another important milestone for Xbrane. The team, together with our colleagues at
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