GPhA Battles State Biosimilar Bills; 5 Passed, 10 Rejected
Generic Pharmaceutical Association wants to assure legislation on biologics substitution does not impose more restrictions than required for small molecules; opposes measures pushed by Amgen and Genentech.
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Sandoz has begun a global Phase III trial with its biosimilar version of Amgen's Enbrel (etanercept), targeting psoriasis rather than the more lucrative indication for rheumatoid arthritis, with the aim of winning quicker regulatory approval which can be built on as it gains insights testing the medicine.
The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.
The partners’ flexibility allows them, together and separately, to establish solid footholds in a still-evolving field with plenty of potential but also uncertainties.