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Canadian report into international policies for biosimilars Posted 16/11/2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report that investigates different international policies on the use of biosimilars [1].

CADTH is an independent, not-for-profit organization responsible for providing healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies in Canada.

The report, which was published by CADTH on 25 October 2018 as part of its Environmental Scan series, had the objective of identifying and comparing international policies to facilitate the adoption of biosimilars.

In 2016, according to CADTH, the 30 top-selling biologicals accounted for 24% of pharmaceutical sales in Canada. The Patented Medicine Prices Review Board (PMPRB) identified a list of 13 biologicals – for which biosimilars have been recently launched or are expected to be launched in the next three years – that accounted for C$3.6 billion in sales in 2016 in Canada.

Canada’s drug regulatory agency, Health Canada, has to date approved nine biosimilars [2]. These biosimilars could potentially be used as low-cost alternatives to high-cost biologicals. However, for a healthcare system to realize these cost savings, successful market uptake of biosimilars will depend on various factors, such as number and timing of entrants into the market, patient and healthcare provider’s understanding and acceptance of biosimilars versus originator biologicals, cost of biosimilars, pricing policies, payer coverage and utilization policies, and policies around interchangeability and substitution.

CADTH therefore carried out a literature search of international policies around these factors to facilitate the appropriate use of biosimilars in Canada in order to have the potential to reduce healthcare expenditure in the country. The search covered documents in English and French published between 1 January 2013 and 17 August 2018.

The findings cover post-marketing policies established in the US, Australia, New Zealand, Finland, France, Germany, The Netherlands, Norway, and the UK to facilitate the appropriate use of biosimilars. They cover the issues of interchangeability, switching and substitution, supply side policies, prescribing incentives, initiatives to promote the use of biosimilars and improve their understanding, and policies specific to biosimilars for the treatment of cancer.

The report identified a range of policies and initiatives that have been proposed and implemented in international jurisdictions to promote biosimilar use through various complementary levers. No policy was identified that focused specifically on oncology biosimilars, although the vast majority of policies reported were meant to include biosimilars for all indications, including cancer treatment.

The report concluded that it had identified a number of policy options for the Canadian healthcare system. However, ‘whether similar policy mechanisms can be applied in the Canadian setting will depend on a complex interplay of factors and the coordinated engagement of a number of stakeholders’.

The findings of the report on the issues of interchangeability, switching and substitution, supply side policies, prescribing incentives, and initiatives to promote the use of biosimilars and improve their understanding covered in more detail in the following series of four articles. 

Related articles
International promotion and education for biosimilars

International prescribing incentives for biosimilars

International supply side policies for biosimilars

International policies for interchangeability, switching and substitution of biosimilars

References
1. CADTH Environmental Scan. International Policies on the appropriate use of biosimilar drugs. October 2018 [homepage on the Internet]. [cited 2018 Nov 15]. Available from: www.cadth.ca/sites/default/files/pdf/es0333_international-policies-on-use-of-biosimilar-drugs.pdf
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada

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Source: CADTH

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