The potential for doctors to contribute to biosimilar guidelines
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 3
Abstract
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.
Authors and Affiliations
GaBI Journal Editor
Keywords
Related Articles
- EP ID EP355662
- DOI 10.5639/gabij.2012.0103-4.039
- Views 109
- Downloads 0
Critical immunogenicity differences will be obscured by a common INN for biosimilars
Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscat...
Generics substitution in primary care: summary of the Dutch community pharmacies guidelines
Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index drugs and t...
First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs), Kuala Lumpur, Malaysia, 8 October 2013
Introduction: In recent years a new category of medicinal products, the non-biological complex drugs (NBCDs) emerged. They are distinct from both the small molecules and the biological therapeutics by being composed of n...
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care
Oncologists urged to embrace biosimilars to help control spiralling costs of cancer care Oncologists have been urged to embrace biosimilar drug substitution to help control the spiralling costs of cancer care. However, t...
A bioethicist’s view of the use of biosimilars
In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From the ethical point of vi...