International recommendations for the use of biosimilars issued
medwireNews: An international taskforce has developed consensus-based recommendations for the evaluation and use of biosimilars to treat rheumatic diseases.
“In the European Union, the USA, Japan and other countries, biosimilars of adalimumab, etanercept, infliximab and rituximab have been approved,” write the authors in the Annals of the Rheumatic Diseases.
However, they note that “little has been published to guide healthcare providers in critically evaluating and differentiating the scientific data available for each of these molecules.”
The taskforce of 25 experts from eight European countries, Japan, and the USA was led by Jonathan Kay (UMass Memorial Medical Center, Worcester, Massachusetts, USA), and comprised specialists in rheumatology, dermatology, and gastroenterology, in addition to pharmacologists, patients, and a regulator.
Kay and colleagues undertook a systematic literature review of published studies and abstracts presented at the ACR and EULAR annual meetings, and used the evidence obtained to develop five overarching principles and eight recommendations, which were accepted when at least 80% of the group agreed.
The five overarching principles recommend that:
- treatment is based on shared decision-making between patients and rheumatologists;
- financial differences in healthcare systems must be considered when choosing an appropriate therapy;
- in a highly regulated area, an approved biosimilar has an equivalent efficacy and safety profile to its reference product;
- patients and healthcare providers should be informed about the nature of biosimilars and their approval process to avoid the misconception that they are of lesser quality than originator drugs; and
- additional safety and efficacy data should be obtained following approval and marketing of biosimilars.
The eight consensus recommendations specify that approved biosimilars can be used in the same way as their reference products, and that their availability must significantly lower the cost of treatment. A single switch to a biosimilar product is recommended, provided that patients and healthcare providers are aware of the change, but the authors stress that the safety of multiple switching between biosimilars needs to be assessed using registries.
The taskforce reached “a high level of agreement” on these principles and recommendations, with between 88% and 100% of the group agreeing on each point.
“The group believed that adequate evidence exists to support the decision to switch from a biologic, which no longer is protected by patent, to its biosimilar,” write Kay and colleagues, noting that “there is sufficient evidence about safety and efficacy of biosimilars to allow for extrapolation of indications.”
And the authors conclude: “Biosimilars now provide an opportunity to expand access to effective but expensive medications, increasing the number of available treatment choices and helping to control rapidly increasing drug expenditures.”
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