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

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.

Celltrion is taking a major step forward in the US with its first direct launch of a biosimilar through its own front-end operation. The Korean firm’s Vegzelma rival to Avastin will be looking to compete with multiple other versions of bevacizumab already in the market.