Japan

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Ahead of being spun out of its parent company Samsung Biologics later this year, Samsung Bioepis has struck an agreement to bolster its presence in another Asian market and one of the largest global pharma markets.

Continuing in its medium-term business plan and company reform, Sawai forecasts its revenue to exceed ¥200bn in the coming fiscal year.

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Three $1bn+ alliances were penned in February, and one exceeded $2bn.

Aurion Biotech is developing a cell therapy for corneal diseases that is cheap enough to produce and can be scaled that it should reach the masses in a way that other cell therapies cannot.

Select Indian drug manufacturers have missed some analyst estimates while Japanese firms continue in their efforts to leave the country’s generic drug supply crisis in the past.

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.