Fulphila is a fillip for Biocon’s fortunes
The recent US launch of Biocon’s Fulphila (pegfilgrastim-jmdb) biosimilar co-developed with Mylan led the Indian firm’s Biologics sales to more than double to Rs3.67 billion (US$50.0 million) in its financial second quarter ended 30 September 2018.
You may also be interested in...
Lupin’s first US biosimilar application, for a rival to Neulasta, has been accepted for filing by the FDA. If approved, the product would join an already crowded market for pegfilgrastim in the US.
Alvogen can sell in the US generic lenalidomide on a volume-limited basis after March 2022, and without volume limitations in early 2026, after settling patent litigation with Celgene relating to the originator’s Revlimid. Dr Reddy's has also settled in Canada.
Alvogen’s Lotus subsidiary and Cambrex are expanding their manufacturing capabilities in Taiwan and Canada respectively. As several firms reveal the results of FDA inspections, the agency slaps United Exchange Corporation with a warning letter.