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
Issues associated with establishing sound pharmacy practices for biosimilars include:
- There may be medical or patient compliance reasons for prescribing a given originator or biosimilar
- Substitution of biosimilars without prescriber rights, e.g. ‘dispense as written’, can undermine these considerations
A joint position paper on switching of biosimilars agreed [2], saying that switching is NOT recommended:
- when the initial treatment choice, e.g. reference product or biosimilar, loses efficacy or when there are tolerability issues
- if the physician feels that on balance a switch is likely to compromise future treatment options for the patient, e.g. with an alternate biological therapy
Policy considerations
Dr Jordan believes that the following need to be taken into account when considering sound pharmacy practices for biosimilars:
- Pharmacy practices should limit biosimilar substitution to interchangeable biosimilars and preserve a prescriber’s right to opt-out1
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
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Safe switching for biosimilars
Biosimilarity does not mean extrapolation of all indications
Biosimilarity is not interchangeability
References
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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