12 January 2016, Brussels, Belgium
GaBI organized the ROUNDTABLE ON BIOSIMILARS with participation by European Regulators and Medical Societies on 12 January 2016 in Brussels, Belgium.
The Roundtable on Biosimilars with participation by European Regulators and Medical Societies is an interactive meeting for academics, medical practitioners/specialists who are key opinion leaders in dermatology, gastroenterology, oncology, (clinical) pharmacology, rheumatology, bone marrow transplantation from various medical societies in Europe from Austria, Belgium, Czech Republic, Finland, Germany, Italy, The Netherlands, Norway, Portugal, Spain and the UK to discuss and exchange information with European regulatory experts on biosimilars focusing on the key issues: comparability, extrapolation, interchangeability and substitution, as well as pharmacovigilance. Thirty-three participants, speakers included, attended the meeting.
Regulators and learned societies, especially medical societies, have prominent roles in guiding the rational use of new medicines, including biosimilars. The guidance of regulators and medical societies should ideally be synergistic and complimentary. The Roundtable on Biosimilars intends to identify areas of consensus, address uncertainty or disagreement concerning the use of biosimilars, and to promote a dialogue between medical societies and regulators on biologicals, including biosimilars.
The meeting focuses on identifying the specific information required by medical specialists/prescribing physicians to enhance their knowledge and trust in the regulation/licensing of biosimilars, and to discuss the need for a direct interface between EU medical societies and regulators
A meeting report of this event has been published in GaBI Journal.
You can download the speakers’ presentation of this roundtable meeting:
European medical societies’ position papers on biosimilars: concerns and controversies
Analytical comparability covering product manufacturing, characterisation, purity and stability of biosimilars
Clinical and non-clinical comparability for biologicals/biosimilars
Unwanted immunogenicity of biotherapeutic products including biosimilars
Principles of extrapolation of indications
Interchangeability and substitution of biosimilars – a German perspective