Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Huge Costs, Amount of Application Data Required Will Be Major Challenges in Development of Biosimilars: Open Forum
Industry officials discussed challenges to promoting the development and use of biosimilars at an open forum on October 8. Most agreed that the high costs of development and the huge amounts of data required in applications for marketing authorization will…
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REGULATORY
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