Introduction: Biological drugs are improving therapeutic options for many diseases, but access to these therapies is being held back by costs. Biosimilars offer a lower-cost alternative to the corresponding original therapeutic protein, the reference product, with a comparable quality, safety and efficacy. Despite these apparent advantages, arriving at the best solution for patients will need improved communication between regulators and caregivers. Methods: Representatives from medical societies (European and national) which had issued or published a position paper on biosimilars met with regulators and related experts to discuss recent revisions of the regulatory assessment principles of biosimilars, review the current positions of societies on biosimilars, and improve dialogue between medical societies and regulators on biologicals, notably biosimilars. Results: The positions of the European regulators and medical societies are slowly converging. While many questions were answered, productive discussions identified areas of disagreement and uncertainties. The results of these discussions will inform debate and decision-making in the participants' organizations and home countries. Conclusions: The picture of biosimilars is becoming clearer, and stakeholders are beginning to understand better the basis of biosimilar development, on one hand, and the reasons for concerns, on the other hand. Different stakeholders - patients, doctors, pharmacists, payers - need different information. Above all, this must be a collaborative exercise. Copyright

Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016 / Annese, V.; Avendano-Sola, C.; Breedveld, F.; Ekman, N.; Giezen, T. J.; Gomollon, F.; Kurki, P.; Kvien, T. K.; Laslop, A.; Puig, L.; Thorpe, R.; Weise, M.; Wolff-Holz, E.. - In: GABI JOURNAL. - ISSN 2033-6403. - 5:2(2016), pp. 74-83. [10.5639/gabij.2016.0502.019]

Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016

Annese V.;
2016-01-01

Abstract

Introduction: Biological drugs are improving therapeutic options for many diseases, but access to these therapies is being held back by costs. Biosimilars offer a lower-cost alternative to the corresponding original therapeutic protein, the reference product, with a comparable quality, safety and efficacy. Despite these apparent advantages, arriving at the best solution for patients will need improved communication between regulators and caregivers. Methods: Representatives from medical societies (European and national) which had issued or published a position paper on biosimilars met with regulators and related experts to discuss recent revisions of the regulatory assessment principles of biosimilars, review the current positions of societies on biosimilars, and improve dialogue between medical societies and regulators on biologicals, notably biosimilars. Results: The positions of the European regulators and medical societies are slowly converging. While many questions were answered, productive discussions identified areas of disagreement and uncertainties. The results of these discussions will inform debate and decision-making in the participants' organizations and home countries. Conclusions: The picture of biosimilars is becoming clearer, and stakeholders are beginning to understand better the basis of biosimilar development, on one hand, and the reasons for concerns, on the other hand. Different stakeholders - patients, doctors, pharmacists, payers - need different information. Above all, this must be a collaborative exercise. Copyright
2016
Biologicals/biosimilars
Extrapolation
Interchangeability
Medical societies
Prescribers
Regulators
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/166118
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