Biotech Values

[DewDiligence]

MNTA TEVA GTCB et al – How is automatic substitution of biosimilar drugs handled by the EU?

It’s a trick question because automatic substitution is not addressed by the EU per se, but rather by the individual countries:

• France, Italy, and Spain do not permit automatic substitution, which makes biosimilar drugs in these countries effectively the same as branded drugs from a selling and marketing standpoint.

• In the UK, Rx’s are generally written by a drug’s International Nonproprietary Name (INN) rather than the brand name; as long as a biosimilar has the same INN as the brand on which it is based, substitution by the pharmacist is permitted.

• In Germany, Rx’s are generally written by the brand name; substitution by the pharmacist is allowed unless the Rx explicitly precludes it (the same approach used in the US for small-molecule generics).

The upshot of all this is that marketing an FoB in the EU is not as simple an undertaking as it will be in the US under most of the proposed FoB bills that Congress has considered to date. On the other hand, biosimilars are already being sold in the EU, and all member countries support the general idea of FoB’s as a means of reducing healthcare costs.