This marks Celltrion’s second regulatory submission for an omalizumab biosimilar as the US formulation patent protecting originator Xolair is set to expire late next year.

Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair. Use of decentralized mode for its Phase III trials is a notable aspect.

Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair, as predicted by Scrip earlier. Use of decentralized mode for its Phase III trials is a notable aspect

Selexis and Generium have claimed the launch of an omalizumab biosimilar in Russia, with their Genolar version of Xolair marking the third biosimilar to be launched by the pair following development with Selexis’ SUREtechnology platform.