WHO guidelines on biosimilars: Toward improved access to safe and effective products

Abstract

The World Health Assembly resolution on access to biotherapeutics in 2014 urges WHO and Member States to facilitate access to biotherapeutics while ensuring their quality, safety, and efficacy. While efforts to date have contributed to increased availability and better access to biotherapeutics, including biosimilars, huge gaps still remain, with lack of product access identified as a problem in many countries. A thorough review of the WHO guidelines on biosimilars issued in 2009 in view of technical developments, accumulated and emerging scientific evidence as well as experience in biosimilar evaluation since the release of the guidelines provided an opportunity to introduce greater flexibility and to reduce regulatory requirements in biosimilar development where possible. Based on the identification, draft revisions of the WHO guidelines were prepared with input from extensive consultation with various stakeholders and the broader public. The move toward a greater emphasis on quality and functional in vitro assessment enables the reduction of cost and timelines of development and supports streamlined regulatory approval as a first critical step toward product availability. This article includes the key updates that have been incorporated in the revised guidelines but are not restricted to these alone and should be read in conjunction with the guidelines.

Estimated Sustainable Cost-Based Prices for Diabetes Medicines

“…However, there are reasons to believe that the costs of bringing biosimilars to market may reduce in coming years. The FDA and the World Health Organization have recently updated their guidance for insulin biosimilars, no longer requiring comparative clinical trials if laboratory analyses and pharmacokinetic and pharmacodynamic studies show high similarity …”

“…The FDA and the World Health Organization have recently updated their guidance for insulin biosimilars, no longer requiring comparative clinical trials if laboratory analyses and pharmacokinetic and pharmacodynamic studies show high similarity. 38 , 39 …”

“…The FDA and the World Health Organization have recently updated their guidance for insulin biosimilars, no longer requiring comparative clinical trials if laboratory analyses and pharmacokinetic and pharmacodynamic studies show high similarity. 38,39 Governments have a range of policy tools, procurement mechanisms, and legal avenues available to reduce the prices of unaffordable medicines. These include, for example, price controls and joint procurement between different countries (pooled procurement).…”

Protein Drug Production

“…Theo hướng dẫn của Cơ quan Dược phẩm Châu Âu (EMA), các nghiên cứu tương đương PK/PD của thuốc tương tự sinh học với thuốc tham chiếu, có thể đủ để công bố tương đương lâm sàng. Chính vì thế, các cơ quan quản lý dược phẩm có qui trình phê duyệt riêng với thuốc tương tự sinh học và Tổ chức y tế thế giới (WHO) đã phát triển các tiêu chuẩn được chấp nhận trên toàn cầu để đảm bảo tính an toàn, hiệu quả và chất lượng của các loại thuốc tương tự sinh học vào năm 2009 [27]. FDA đã thiết lập quy trình cấp phép đối với thuốc tương tự sinh học năm 2010, cấp phép phê duyệt thuốc filgrastim vào năm 2015 (Zarxio, một thuốc tương tự sinh học với Neupogen của Amgen, đã được EMA phê duyệt ở Châu Âu vào năm 2009).…”

Biosimilar drug lag and evolution in Malaysia: A retrospective analysis of regulatory approvals

“…Although regulatory approval does not always imply market availability, it is a necessary condition for market entry in many countries. Therefore, the absence or delay in biosimilar approval in a country may result in a of affordable treatment alternatives to innovative biological products [9,10].…”