This article was originally published in RAJ Devices
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Industry associations in the US and Canada have welcomed revisions to the proposed US-Mexico-Canada trade agreement that remove potentially damaging provisions around biologic data exclusivity and include measures favorable to generics, including incentives for generic competition.
NeuClone has reported that its NeuCeptin proposed biosimilar trastuzumab has successfully met all primary and secondary endpoints in a Phase I clinical trial.
Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.