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The potential for doctors to contribute to biosimilar guidelines

Author(s): GaBI Journal Editor

Journal: Generics and Biosimilars Initiative Journal
ISSN 2033-6403

Volume: 1;
Issue: 3-4;
Start page: 152;
Date: 2012;
Original page

Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European regulatory authorities. This level of distrust may reflect a lack of engagement by the regulatory authorities with the medical community during the development of the guidelines, with the result that their views were not taken into account before publication of the guidelines, according to Hans C Ebbers and co-authors. The authors suggest that the situation can be resolved by doing more to build confidence among physicians and patients in the regulatory process by encouraging representatives of medical associations to contribute more to public consultations. This would ensure guidelines for the approval of biosimilars meet the needs of all stakeholders, and enable more patients to gain access to them.
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