Biotech Values

[DewDiligence]

Re: Musings on competitive landscape for FoB’s

Do you think the EU and other jurisdictions will eventually introduce guidelines on interchangeability for biosimilars? AFAIK, only the FDA has developed guidelines to address this.

A key difference: US had the Hatch-Waxman framework to build on when devising the 351(k) pathway for FoB’s; this framework is lacking in other countries, which makes it harder for them to incorporate interchangeable FoB’s. Note that the EMA does not even approve interchangeable small-molecule drugs; instead, small-molecule generics are handled at the country level.

…the need to market biosimilars that are not interchangeable may actually be a positive for Sandoz and other big players, as it places a higher [financial] barrier to entry than for small-molecule generics. I think there may be several players initially, but being unable to compete on price alone will probably mean that many smaller players will not survive.

Quite so. Small generic-drug companies may be able to compete in their home market or a small regional superset, but they lack the marketing and regulatory infrastructure to develop global FoB brands as the big players are seeking to do.