Biosimilars Wedge Issue: Actavis Splits With GPhA In Supporting Calif. Notification Bill
PhRMA, BIO and Abbvie also back California bill that would require pharmacists to notify physicians of biosimilar substitution while GPhA, Boehringer Ingelheim and Novartis oppose it.
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The partners’ flexibility allows them, together and separately, to establish solid footholds in a still-evolving field with plenty of potential but also uncertainties.
Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.