One reason perhaps is that although the Russians seem to be keen on such a regime, the US has not elicited enough concessions in principle on law enforcement to make this worthwhile from their perspective (notwithstanding the probable lack of practical effect of such an agreement also).
The bottom line is that for the time being, from a regulatory perspective each biosimilar version of an approved biological product will be regarded as, in effect, a completely new and distinct drug.
Although my conversation with Ms. Gentile certainly helped put things in perspective, it was the surprise phone call I received from an anonymous espnW supporter that really had an effect on my view of the situation.
Is the magnitude of effect, if any, associated with acupuncture for a given clinical indication 'worth it' from the perspective of patients, payers, or policymakers?