PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
Biosimilar Efficacy Trials Can Be Waived under Certain Conditions: MHLW
Japan’s health ministry has clarified that comparative clinical efficacy trials for biosimilars can be omitted if sufficient data demonstrate biosimilarity to the reference biologic through pharmacokinetic (PK) or pharmacodynamic (PD) studies. The Ministry of Health, Labor and Welfare (MHLW) clarified…
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