Biotech Values

[DewDiligence]

MNTA—When the FDA approves FoBs, are they 100% sure they are exact copies…?

Only when the FDA confers interchangeable status on the approved FoB, which has not happened for any of the FDA-approved FoBs to date. When the FDA approves an FoB without interchange status, the FoB has to be highly similar to the branded product in structure and PK/PD, which is a lower standard.

How difficult of a drug is Enbrel to copy? Any idea if other companies can do this as easily as MNTA?

Enbrel is somewhat harder than most biologics to reverse engineer because it’s a fusion protein. I don’t know which companies (other than MNTA) are capable of obtaining an FDA-approved, interchangeable Enbrel FoB; as a practical matter, few companies are developing Enbrel FoBs for the US market because of AMGN’s long-running patent protection.

For example, could MNTA show that a competitor’s Humira is not identical [to branded Humira]?

They probably could, once they are able to obtain the FoB on the open market following its commercial launch.