Biotech Values

[DewDiligence]

The shortcut is not having to prove that the Rituxan biosimilar has efficacy in NHL in a set of full-fledged phase-3 trials (plural), as would need to be done in a traditional BLA submission, but rather being able to show similar safety and efficacy to Rituxan in a less demanding phase-3 trial (singular). Moreover, phase-2 for the biosimilar can probably be eliminated altogether, so it can progress directly from phase-1 to phase-3.