A new medicine to protect newborns and infants from RSV infection and a new treatment for DLBCL are among a dozen drugs that have been recommended for pan-EU approval.

Stada and Xbrane have celebrated an endorsement from the EMA’s CHMP for their Ximluci ranibizumab biosimilar rival to Lucentis. The development follows a setback for a parallel filing in the US.

Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.

Xbrane has set out its plans to resubmit its application for a biosimilar rival to Lucentis in the US, after receiving details from the FDA on additional information needed for the agency to accept the BLA for review.