Reply to Comment on “Market Exclusivity for Drugs with Multiple Orphan Approvals (1983–2017) and Associated Budget Impact in the US”
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DOI: 10.1007/s40273-020-00973-9
Abstract: We appreciate the interest that Manning and readers have shown in orphan drug policy [1]. The incentives established in the 1983 Orphan Drug Act have undoubtedly become a success story helping to create new markets… read more here.
Keywords: market exclusivity; generic biosimilar; market; drug ... See more keywords
On safety margin for drug interchangeability
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DOI: 10.1080/10543406.2016.1265540
Abstract: ABSTRACT As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can… read more here.
Keywords: safety; generic biosimilar; biosimilar drug; drug ... See more keywords