16 June 2022

Will Authorised Biologics Deter Biosimilars Utilising JFTC's Expertise in Drug Pricing

In the US, the impact of authorised biologics on biosimilars is post-regulated by the competition authorities, while in Europe, pharmaceutical regulatory authorities consider competition impacts in addition to post-regulation by the competition authorities.

In Japan, it is pre-regulated by the Ministry of Health, Labour and Welfare (MHLW) and the Central Social Insurance Medical Council (CSIMC), which consider competition at the point of drug price listing.

Should the MHLW and CSIMC consider competition in drug pricing, it would be necessary to formulate systems to utilise the expertise of a competition expert, namely the Japan Fair Trade Commission.

In this webinar, Takanori Abe will unpack the impact of authorised biologics on biosimilars, from the perspective of competition policy and health policy, exploring issues such as:

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