Sound pharmacy practices for biosimilars Posted 12/05/2017

To address the four key considerations for biosimilar interchangeability Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen outlined five principles during his presentation at the SMi 3rd Annual Biosimilars USA Conference [1]. The fourth of these principles is that there should be sound pharmacy practices for biosimilars.
Issues A joint position paper on switching of biosimilars agreed [2], saying that switching is NOT recommended:
Policy considerations 1The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has stated that it ‘encourages’ the inclusion of protections for any framework permitting pharmacy-mediated interchangeability of biotherapeutics, such as ‘provisions permitting prescribers to pre-empt a generic drug substitution’. However, the IFPMA has also stated that ‘prescriber ‘opt out’ provisions are not the same concept as ensuring prescriber involvement in the decision to switch a patient. Therefore, these provisions should not be used to justify substitution of SBPs [Similar Biotherapeutic Products] that have not been designated as interchangeable’.
Related articles Safe switching for biosimilars Biosimilarity does not mean extrapolation of all indications Biosimilarity is not interchangeability
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Issues associated with establishing sound pharmacy practices for biosimilars include:
Dr Jordan believes that the following need to be taken into account when considering sound pharmacy practices for biosimilars:
Product-specific pharmacovigilance
1. Jordan B. Regulatory implications for implementing biosimilar interchangeability: addressing policy and practical concerns. SMi 3rd Annual Biosimilars USA Conference; 16-17 November 2016; Iselin, New Jersey, USA.
2. GaBI Online - Generics and Biosimilars Initiative. Pharma associations issue position paper on biosimilar switching [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/General/Pharma-associations-issue-position-paper-on-biosimilar-switching
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