The safety of monoclonal antibody use in pregnant women was examined. The use of the monoclonal antibodies in pregnant women is not defined; therefore, it is unknown whether they should be given only if needed, or they should be avoided during pregnancy. We studied 43 review reports of new monoclonal antibodies approved before FY2016 in Japan, and found that there were two types of summary of pregnant animal toxicology. According to toxicological studies, they were harmful for pregnant animals and fetal development, or their safety was not clear because the toxicological studies were not performed according to ICH guidelines (ICHS6 [R1]). The Pharmaceutical and Medical devices Agency (PMDA) evaluated the risk-benefit balance of these antibodies by pharmacological and immunological data. The PMDA concluded that the toxicological data was not sufficient for evaluation, and that the monoclonal antibodies should be avoided in pregnant women. The prescribing information for pregnant women was different among the Food and Drug Administration, European Medical Agency, and the Ministry of Health, Labour and Welfare. Moreover, the prescribing information for these drugs in Japan may be too simplified for both pregnant women and pharmacists. The understanding of these monoclonal antibodies by pregnant women is likely dependent on communication with the pharmacists. We found important scientific information in the review reports. As the risk-benefit balance is explained to patients by the pharmacists, pharmacists in Japan need to have more information regarding monoclonal antibodies.

We, members of Welfare Labor Science Research “Investigational research of problems to solute for the promotion of biosimilar use”, investigated problems for promotion of biosimilar use and made proposals to solute those problems for pharmaceutical industry, academia and government (see conclusion).

Development of biosimilars is expected to contribute to a decrease in currently soaring medical costs, thus increasing in the number of approved biosimilar products is encouraged in the recent government policy. The quality target product profile (QTPP) of biosimilars is equal to that of the reference product. During the comparability assessment and establishment of the control strategies, it is important to identify the critical quality attributes (CQA) and to determine their appropriate range, which is based on the risk assessment aimed to ensure the efficacy and safety. Knowledge around the quality attributes of biosimilars may be limited because the scale of clinical studies of biosimilars is smaller than that of other innovative products. However, after marketing authorization approval, lifecycle management of biosimilars is required, which is also the case for other innovative products. Therefore, during the development of biosimilars, it is necessary to obtain substantial knowledge of the impact of quality attributes on efficacy and safety, as well as the impact of process parameters on quality attributes. In this review, recent topics on the regulatory requirements, characterization, and control strategy of biosimilars are introduced.

Advances in biotechnology led to a variety of commercially available biologics with reported clinical efficacy. Many biosimilars have been developed and some are currently on the market in the EU, Japan and the US after the expiration of market exclusive rights of original innovator biologics. The market share of biosimilars is growing steadily year by year, representing global and Japanese biosimilars market at 1.6 billion dollars and 18.4 billion yen, respectively, in 2016. Moreover, the market share of biosimilars is expected to expand further in the future. As a result of calculating market shares of five biosimilars in Japan based on the unit sales of innovators and biosimilars, they are 4.2%–90.2%. It was revealed that the market shares are greatly different with each product. Various factors derived from each product and its clinical usage, such as the product property, its market environment, physician’s treatment decisions and policies, may influence the biosimilar penetration. So, some efforts including new government policymaking toward the further penetration of biosimilars in Japan should be considered from a variety of perspectives. The Japanese Government issued a basic policy on economic and fiscal management and reform 2017 where necessary governmental support to enhance R&D capability for originating innovative biologics as well as biosimilars in Japan was noted. It is expected that such support leads both the further penetration of biosimilars and accelerating the development of the biopharmaceutical industry in Japan in the future.

Regulations regarding reprocessed single-use medical devices (R-SUDs) were introduced in Japan in July 2017. R-SUDs are single-use medical devices collected from hospitals by the manufacturer for reuse after cleaning, sterilization, and performance testing. Regulations for R-SUDs have been implemented in some foreign countries already, but the regulations in each country differ. The regulations for R-SUDs in the United States (US) were referred to when drafting the regulations in Japan. Specifically, in the early phase of drafting the regulations, the technical aspects of the US regulations for R-SUDs were investigated regarding the review of medical devices, and the essential requirements were used as guidelines for the Japanese R-SUD regulations. This article describes the perspective of the author, who participated in the planning and drafting of the regulations. The important requirements for reprocessing SUDs are the reverse engineering of the original medical devices and the cleaning and sterilization methods, which were found to be suitable guidelines for the R-SUD regulations in Japan. The manufacturers, users, and patients need to fully understand the principles of R-SUDs, and the author hopes this article helps those seeking to reprocess SUDs or use R-SUDs to implement and follow the R-SUD regulations in Japan reasonably and effectively.