Japan's MHLW approves 367 generics, but what does this mean?

Japan’s Ministry of Health Labor and Welfare (MHLW) approved 367 items of generic drugs last week. Launch of the approved generics will be in December when they are price listed into the National Health Insurance (NHI) reimbursement table, reports The Pharma Letter’s local analyst.

Based on the current rule, NHI price listing takes place twice a year in June and December. The NHI price listing of generics by MHLW is made upon manufacturers’ requests and confirmation of capability to maintain stable supply.

The best-selling product, with sales of 108 billion yen ($1.11 billion) last year (2012), is Swiss drug major Novartis’ (NOVN: VX) ARB anti-hypertensive drug Diovan (valsartan), which is among the original branded drugs that are anticipating entry of generic competitors in December.