Features
March / April 2019

Generics: Industry Perspectives from Four Locales
Emily Burke
Tsunehiro Togashi
Richard Simon Regalado Binos
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The market for generic drugs continues to grow. Consider these developments

  • The US FDA approved a record number of generics in 2018.1
  • Generics are taking an increasing share of the value market around the world. In North America between 2006 and 2016, volume grew from 52% to 70% while value rose from 16% to 23%. And a record 86% of prescriptions were reportedly dispensed as unbranded generics in 2017.2
  • The global generic drug market was valued at around $244.5 billion USD in 2017, growing at a compound annual growth rate of around 8% during 2010-2017.3
  • One estimate anticipates a compound annual growth rate of more than 10% from 2018 to 2022.4

In recognition of the growth and importance of generics to the pharmaceutical market, Pharmaceutical Engineering takes a look at what’s happening in some very diverse global markets. Four articles provide “snapshots” of developments with generics, biosimilars, the drug shortage problem, and expansion into nondomestic markets, just to name a few trends. A technical case study of an innovative approach to lyophilization using QbD to revalidate a commercial injectable drug product as part of a transfer to a new line.

The Generics Cover Story in this issue of Pharmaceutical Engineering contains four articles:

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India: Highlights of some changes in India that demonstrate the growing commitment to quality and GMP by Pharmaceutical Engineering freelance writer Emily Burke.

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China: Information about regulatory reforms in China and predictions from market observers about the impact on quality by Pharmaceutical Engineering freelance writer Emily Burke.

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Japan: Tsunehiro Togashi, Managing Director of CM Plus Singapore Pte. Ltd., works in Japan and other Asian markets. He gives an overview of established generics producers in Japan and their journey to expand into the Southeast Asia market and beyond.

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The Philippines: Richard Simon R. Binos, Health Systems and Market Access Officer of the Pharmaceutical & Healthcare Association of the Philippines, provides a look into the burgeoning biosimilars market.

Varied Views

Each article provides an overview as described above to expand ISPE members’ knowledge and understanding about the activities and trends impacting colleagues in other countries. Each article offers different viewpoints and varied approaches.

These articles are not meant to be all-inclusive about the respective countries and are limited to exploration of generics and/or biosimilars. One author (Burke) is an industry observer, while the others are part of the action—these different views provide a variety of insights and information for Pharmaceutical Engineering readers.

These profiles do not encompass a complete worldview of the generics market. They provide a unique perspective and may bring new information and updates to ISPE members about activities in the important sector of generics.

Pharmaceutical Engineering welcomes additional submissions on generics topics and comments. More information about generics and biosimilars will help all members around the world to learn more about the progress that is being made with the production of these drugs.