Stada And Xbrane Win EU Endorsement For Ranibizumab
Ximluci, Third Biosimilar Rival To Lucentis, Receives Positive Opinion From CHMP
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.
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Coherus BioSciences has heralded a “strategic inflection point” for the company after receiving USFDA approval for Cimerli as an interchangeable biosimilar rival to Lucentis. The firm has also revealed launch plans for the Bioeq-partnered ranibizumab product.
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.
Formycon has seen its FYB201 ranibizumab biosimilar rival to Lucentis recommended for approval by the EMA’s CHMP, under the name Ranivisio. Teva has rights to market the product in Europe and is preparing for launch.