Scope and aim
Assessment of bioequivalence is considered one of the key elements in the development and registration of new medicinal products. In case of generic medicinal products it is the essential basis for product approvals worldwide. At the same time, it is quite apparent that bioequivalence regulations and guidances still differ to certain extent from country to country and region to region. This does not only complicate the processes for pharmaceutical industry, but also impedes a comparison between products registered and marketed in different parts of the world. As the underlying scientific basis for deeming a new generic drug product as safe and effective is the same all over the world, it seems reasonable to combine the experience gathered from regulatory procedures in the different regions and harmonize them around the globe accordingly. Finally, ethical considerations also should be taken into account in order to avoid unnecessary repetition of BE studies only due to slightly deviating requirements.
Global Bioequivalence Harmonization Initiative (GBHI)
Already several years ago the European Federation for Pharmaceutical Sciences (EUFEPS), with its Network on Bioavailability and Biopharmaceutics (BABP) in the lead, has started an initiative to harmonize the requirements for bioequivalence assessment. This intention was from the beginning encouraged by the European Medicines Agency (EMA) as well as the US Food and Drug Administration (FDA). In order to support the intended process of global harmonization scientifically, a series of International Conferences was started by EUFEPS in collaboration with the American Association of Pharmaceutical Scientists (AAPS). The first one was held in 2015 in Amsterdam/The Netherlands followed by a second one in 2016 in Rockville/USA and a third one in 2018 again in Amsterdam. All conferences were characterized by open discussions and constructive exchange between regulatory scientists, academia and industry and, thus, contributed significantly to the debate on a worldwide harmonization of bioequivalence requirements. Also regulators and speakers from other countries/regions, e.g. Canada, Chile, China, India, Japan, Jordan, Mexico, and Brazil, attended and contributed to the discussions. Such global participation forms an ideal platform for scientists from the pharmaceutical industry and academia to exchange their experience and views with the regulators. Scientific consensus achieved at the end of processes such as these, should constitute the most appropriate basis for harmonization.
In order to disseminate the outcome more intensively, conference reports have been edited. The first two have been published in the European Journal of Pharmaceutical Sciences and the third is in preparation.
4th GBHI Conference and expected outcome
This 4th conference of the Global Bioequivalence Harmonization Initiative will take place in Bethesda/Washington, USA, from December 12-13, 2019.
Topics of this conference were selected by an International Scientific Planning Committee with the intention of identifying differences with realistic chances for harmonization based on the scientific state of the art. To achieve this objective, the BE-related topics selected for discussion include BE assessment for implants/long-acting injectables and for orally inhaled products as well as the necessity of fed BE studies in case of immediate release products.
Moreover, aspects which remained still unresolved in the previous conference will be taken up again with the intention to achieve further consensus. This may also include preliminary discussion on the definition of a Global Reference Product.
Based on the positive experience with the previous GBHI conferences in 2015, 2016 and 2018, the Scientific Committee expects intensive discussions between the regulatory scientists of the involved Agencies and the auditorium. Attendees may receive useful information for advanced designing of BE programs to find acceptance in all regions.
This process should be in the interest of and supported by the regulatory agencies, industry and academia, on a global level. Scientists from all countries and regions of the world (Africa, Asia/Pacific, Australia, China, Europe, India, Japan, North and South America) are invited to contribute actively during the open discussions. Attendees are thus encouraged to share their experience in the issues under discussion.
Henning Blume, SocraTec C&S, Oberursel/Germany
Mehul Mehta, FDA, Silver Spring/USA
Scientific Planning Committee
Gerald Beuerle, ratiopharm, Ulm/Germany
Henning Blume, SocraTec C&S, Oberursel/Germany (chair)
Angelica Dorantes, FDA, Silver Spring/USA
Georg Hempel, University of Münster/Germany
Wenlei Jiang, FDA, Silver Spring/USA
Andreas Kovar, Sanofi, Frankfurt/Germany
Mehul Mehta, FDA, Silver Spring/USA
Henrike Potthast, BfArM, Bonn/Germany
Gustavo Mendes Lima Santos, ANVISA, Brasilia/Brazil
Barbara Schug, SocraTec R&D, Oberursel/Germany
Anne Seidlitz, University of Greifswald/Germany
Nilufer Tampal, FDA, Silver Spring/USA
Yu-Chung Tsang, Apotex, Toronto/Canada
Jan Welink, MEB, Utrecht/The Netherlands