In his presentation at the SMi 3rd Annual Biosimilars USA Conference, Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen, outlined five principles that address four key considerations for biosimilar interchangeability [1]. The second of these principles is that biosimilarity does not mean extrapolation of all indications.
Issues
Issues associated with extrapolation of indications for biosimilars include:
- Biosimilarity in one indication does not intrinsically prove biosimilarity in all other indications
- A pharmacist should never be asked to verify a patient’s medical condition before dispensing a medication
Examples
1. European epoetin alfa biosimilar initially not approved for subcutaneous route of administration due to inadequate evidence. The epoetin alfa biosimilar Binocrit was originally marketed in the European Union (EU) in August 2007 for anaemia and chronic kidney failure via the intravenous route only. However, in April 2016, the European Commission (EC) approved a type II variation for the addition of a subcutaneous route of administration for Binocrit’s nephrology (kidney function) indication [2].
2. Canadian biosimilar infliximab initially not approved for inflammatory bowel indications due to inadequate evidence. Inflectra was originally approved by Health Canada in January 2014 for treatment of patients with ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis. [3]. Then in June 2016 that approval was extended to cover three extra indications: Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC). Approval for CD and UC was originally not granted ‘due to differences between Inflectra and Remsima and their respective reference products’ [4].
Policy considerations
Dr Jordan believes that the following need to be taken into account when considering biosimilars and extrapolation:
- Only biosimilars that meet the regulatory criteria for full extrapolation should be interchangeable at the pharmacy
- Exception: label ‘carve-outs’ for exclusivity (IP protected indications)
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has stated that ‘competent authorities should designate interchangeability only if the SBP [similar biotherapeutic product] meets the regulatory requirements for all indications and conditions of use (for example, patient populations and routes of administration) for the RBP [reference biotherapeutic product] and is licensed for all accessible indications for the RBP’.
Related article
Product-specific pharmacovigilance
Sound pharmacy practices for biosimilars
Safe switching for biosimilars
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. New administration route for epoetin alfa biosimilar Binocrit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 28]. Available from: www.gabionline.net/Biosimilars/News/New-administration-route-for-epoetin-alfa-biosimilar-Binocrit
3. GaBI Online - Generics and Biosimilars Initiative. Infliximab SEB launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 28]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-SEB-launched-in-Canada
4. GaBI Online - Generics and Biosimilars Initiative. Health Canada approves Inflectra biosimilar for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 28]. Available from: www.gabionline.net/Biosimilars/News/Health-Canada-approves-Inflectra-biosimilar-for-extra-indications
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