Replies to post #208155 on Biotech Values

[jbog]

BICK,

Didn't read everything but my takeaway at this point is interchangeability will be governed more by trials than the lab. Deep pockets can win this one.

[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.

[indigokid]

After reading this article I think Barclays is incorrect. I think MNTA has specifically planned for all of the guidelines for an interchangeable Humira. Amgen went for biosimilar not interchangeable as have most other players and will likely miss the bar for interchangeability.