Multi-dimensional Focus on the Management and Clinical Use of Biosimilar Products / 中国药房

OBJECTIVE：To provide reference for summarize the management and clinical use levels of biosimilar products . METHODS：Related policies and regulations about approval and application of biosimilar products were retrieved from domestic and foreign supervision departments and WHO. The biosimilar products were described from multi-dimensional aspects of whole life cycle of drugs ，generic name and prescription ，indication extrapolation ，clinical drug exchange ，pharmacovigilance，medical insurance payment system ，education and training. RESULTS & CONCLUSIONS ：Biosimilar products refer to therapeutic biological products which are similar to the reference drugs which have been approved for marketing in terms of quality ，safety and effectiveness. In R&D ，production，circulation，use and supervision links，the management of biosimilar products has its own characteristics in different countries/areas/organization. In the R&D stage ，biosimilar products do not need to independently verify their safety and effectiveness ，but only step by step use analytical methods to gradually clarify their high similarity with reference drugs in terms of structure and function. The name of biosimilar products in China is the same as that of the original drugs ，and the general name was used in prescription. For FDA to approve the indication extrapolation of biosimilar products ，it needs to be based on the data and information at the time of application ，the safety and effectiveness information of reference drugs ，and the consideration of relevant scientific elements of indications. It needs to be evaluated and used conditionally under supervision. The standard of FDA approval is strict，that is to say ，the approval standard of realizing interchangeability is higher than that of biological similarity which has no such concept in China. The enterprise community ，regulatory agencies ，academic institutions and hospital drug rooms need to communicate and exchange ，and further strengthen post market risk control and safety monitoring. China’s medical insurance department should establish an appropriate payment system and encourage the use of biosimilar products through the payment system. Meclical workers should learn the characteristics of biosimilar products so that they can make good use of biosimilar products in practice on the basis of understanding their technical evaluation.

What do oncologists need to know about biosimilar products?

Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic product. Biosimilar products for erythropoietin, granulocyte colony-stimulating factor, trastuzumab, and rituximab are already available, and the regulatory processes in various countries are constantly evolving. It is important that oncologists be familiar with the potential issues surrounding the clinical use of biosimilar products. In this review article, we provide background information about biosimilar products and their regulatory approval processes, followed by a discussion of individual biosimilar drugs.

Japanese regulation of biosimilar products: past experience and current challenges.

Seven biosimilar products have been approved in Japan since the March 2009 publication of the 'Guideline for quality, safety and efficacy assurance of biosimilar products' by the Ministry of Health, Labor and Welfare (MHLW). Four years previously, the 'Guideline on similar biological medicinal products' was issued in the European Union (EU), and 13 products as of February 2016 have been approved as biosimilar. The US Food and Drug Administration (FDA) approved the first biosimilar product in the US in March 2015 and final Guidance was issued at the end of April 2015. Over the past decade, the challenges regarding the development of biosimilar products have been discussed extensively. In this article, the data packages of biosimilar products in Japan are compared with those overseas in order to clarify the concepts used by the Japanese regulatory authority, i.e., the Pharmaceuticals and Medical Devices Agency (PMDA). The challenges in the development of biosimilar products in Japan are also addressed.