Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Complete Response Letter Flags Two Issues, Although No More Clinical Trials Required
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.