Japan

Generics Bulletin reviews the latest regulatory developments across the world.

While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.

As efforts to improve diversity in clinical trials gain momentum globally, regulators in the UK, the EU, Canada, Australia and Japan were asked about their efforts to support representative enrolment. 

Celebrating its first birthday as a transformed and integrated company, Biocon casts a wider net for its ustekinumab biosimilar.

This year, regulators questioned the US interchangeability designation and the need for comparative efficacy trials, while finding ways to promote biosimilar development and accessibility. Will this momentum continue in 2025? Generics Bulletin spoke to experts from across the industry to hear their views.

Medtech innovators in the APAC region have in recent years seen a slowdown in investment following a combination of rising costs, supply chain challenges and inflationary pressures. But there is light at the end of the tunnel, says MedTech Innovator APAC leader Fredrik Nyberg.

The divestment decision comes years after it slimmed down amid challenges in the Japanese generic market.

Sawai has teed up multiple new launches in Japan after reporting the listing of five generics across ten presentations in the country’s National Health Insurance drug price list. The new registrations come after the firm reported lukewarm first-half results amid ongoing domestic supply issues.

As it delivered financial first-half results, Japan’s Towa raised its full-year forecast after seeing continued strong demand in Japan and in anticipation of a lower than predicted R&D spend.

After past challenges caused by reimbursement drug price cuts imposed by the Japanese government, Chemiphar has managed to keep its operating profits in the black in the second quarter of its 2024 financial year.