On the Manufacturers of Biosimilars in Asia

Abstract

Over the past 2 decades, biosimilars have created an opportunity for access to affordable medicines globally. The development process includes robust analytical and functional comparability, equivalent pharmacokinetic profile, and demonstration of lack of any meaningful clinical differences. In this brief opinion article, we offer an overview of the major aspects that are involved in biosimilar development and regulatory requirements in Asia in order to facilitate a standardized process that can enable cost‐effective development of biosimilars.

Advancing Innovations in Biosimilars

“…They call for educational efforts to highlight the rigor of studies that support the approval of biosimilars—including the clinical pharmacology studies—and the benefits of biosimilars, thereby increasing the awareness, building the confidence, and ultimately improving biosimilar acceptance. Sheth et al 11 . share the view on the importance of education.…”

“…Arato 12 and Wang 10 discuss perspectives from Japan and Canada, respectively. European Public Assessment Report website 19 Health Canada website 20 Paper by Arato 11 , PMDA website 21 PMDA, Pharmaceuticals and Medical Devices Agency. a Products approved as generic drug under Abbreviated New Drug Application (ANDA) or 505(b) (2) NDA.…”

“…They call for educational efforts to highlight the rigor of studies that support the of biosimilarsincluding the clinical pharmacology studies-and the benefits of biosimilars, thereby increasing the awareness, building the confidence, and ultimately improving biosimilar acceptance. Sheth et al 11 share the view on the importance of education. The issue of patient out-of-pocket costs is discussed in a research article by Feng et al 17 In summary, biosimilars are only available for a small portion of the marketed biologic products, highlighting an urgent need to ramp up biosimilar development and increase efficiency in generating high quality data to support regulatory approval.…”

“…Other articles focus on characterizing the relationship between product quality characteristics (e.g., structural and functional characterization) and clinical performance to further streamline clinical development. [7][8][9] Global alignment of regulatory expectations for biosimilar approval makes biosimilar development more efficient and attractive to sponsors, and we are happy to see articles in this issue from regions around the world; in addition to the United States, this includes articles with viewpoints from Canada, 10 Europe, 7 India, 11 and Japan. 12 Finally, other articles focus on the importance of educating clinicians and patients about biosimilars and assessing the cost to patients.…”