European and Japanese generics groups view opportunities on biosimilars

The European Generic Medicines Association (EGA) participated in several meetings with Japanese government officials and regulators, the Japanese Generic Medicines Association (JGA), the Nippon Keidanren (Japanese Industry Association) and the European Union Delegation to Japan to promote regulatory cooperation on generic and biosimilar medicines as part of the EU-Japan free trade negotiations.

Japan and the EU share similar objectives to promote generic and biosimilar medicines as key components of sustainable health care models. The EGA is supporting efforts to improve regulatory cooperation in this field, notably on the single development for the approval of biosimilar and complex specialty generic medicines to avoid the unethical duplication of clinical studies and on the mutual recognition of Good Manufacturing Practice (GMP) inspections to reduce duplicative inspections. Biosimilars are therapeutically similar copies of biologic drugs.

“Japan is facing an increasing demand for health care due to its aging population. Regulatory cooperation with the EU will help Japan reach its generic medicines targets and will increase the use of biosimilar medicines making healthcare more sustainable for Japan and for patients,” said Adrian van den Hoven, director general of the EGA.

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