Biotech Values

[DewDiligence]

(MNTA)—From the Same FierceBiotech write-up:

Barclays analysts wrote Tuesday that the draft guidelines set a “high bar” to win interchangeability, “most notably requiring switching studies include two exposure periods for each product” [emphasis added].

Having two exposure periods for the branded product and the FoB hardly seems like an onerous requirement for most biologics; it involves a total of four individual switches.

For a drug dosed every 3 months or longer, four switches might results in inordinately long clinical trials; however, for a typical biologic that is dosed every 1-4 weeks, four switches is no big deal, IMO.