Remsima's US FDA review held back by contradictory demands, says Celltrion
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.
Biomay has licensed a yeast-based expression system from fellow Austrian biotech VTU Technologies to use for the commercial production of its recombinant allergens.