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NP1986

08/21/12 9:16 PM

#147441 RE: DewDiligence #147368

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.

IMO, 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 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.