Biotech Values

[DewDiligence]

Re: FoB pathway

…Aggarwal says that the FDA's latest stab at outlining the approval process for biosimilars highlights just how complex and expensive this will be. Add in an even tougher approval process that will be needed to achieve interchangeability—the right for pharmacists to substitute a branded biologic with a biosimilar—along with increasing signs that payers and providers won't settle for anything less, he adds, and you have a recipe for failure.

The recipe for most companies to fail is exactly how MNTA wants it. The higher the hurdle for FDA approval, the more valuable MNTA’s enabling technology becomes.