Shots:

• The US FDA offers a general advice letter with comments & recommendations for the resubmission of the BLA for the biosimilar candidate to Lucentis, based on the preliminary review. In 2022, the company is anticipated to resubmit the BLA
• Xbrane withdrew the BLA for its biosimilar candidate to Lucentis at the end of May while the FDA stated that additional information was necessary to make the decision to accept the BLA and initiate a full review within 60 days post resubmission
• The company will advance its biosimilar candidate towards approval in the US to offer patients with serious eye disease an affordable therapy option

Ref: XBRANE | Image: XBRANE