Biosimilars hold the potential to free up precious resources for reinvestment in new treatments in the developed nations, while improving market access for developing economies. Consequently, it is easy to see why these lower-cost alternatives to premium-priced biologics are among the hottest topics in the pharmaceutical industry.
However, in countries with no formal biosimilars regulatory guidance, such as China, domestic, non-innovator copies of multinational, branded biologics have been approved without clinical data to support comparability to the innovator brand; as a result, the quality of these non-innovator versions can be inferior. Chinese regulators are in the process of developing an abbreviated approval process for biologics that could open up the Chinese market to true biosimilars however. China is not alone in allowing follow-on biologics to be approved without clinical comparability data; non-innovator biologics are also available in South Korea, but a formal biosimilars pathway, based on the European process, has been in place since 2009. In order to understand how perceptions of biosimilars vary between these key Asian growth markets, we surveyed Chinese and South Korean specialists. Primary research in the G7 markets has highlighted that oncologists are more willing to adopt biosimilars than endocrinologists, and with this in mind, we surveyed both of these groups of specialists in China to understand if this trend exists in growth markets.
Questions Answered in This Report:
Understanding where biosimilars legislation is already in place and which non-innovator biologics are already available is critical to understanding the landscape and opportunity for biologics. Which countries have biosimilars legislation or guidance in the Asia-Pacific, and which biosimilars are in the pipeline in South Korea and China?
Familiarity with the concept of biosimilarity, perception of biosimilars’ similarity compared with the reference brand, and level of comfort with indication extrapolation are all key parameters for assessing future physician uptake of biosimilars. How does physician familiarity with biosimilars in China and South Korea compare with European physicians? Will South Korean and Chinese physicians accept a biosimilar that does not have supporting clinical data in all indications that the reference product has approval for?
The quality and physician acceptance of locally produced, non-innovator copy biologics is highly variable by drug class and therapeutic specialty in China and South Korea. Do surveyed oncologists in these countries differentiate between biosimilars and non-innovator biologics in terms of similarity to the originator brand?
Markets covered: South Korea and China.
Primary research: Online survey with 286 specialist physicians: 86 Chinese endocrinologists from Class IIIA hospitals who treat at least 40 type II diabetics per month; 100 Chinese oncologists from Class II or III hospitals who treat at least 10 breast cancer patients and 5 non-small-cell lung cancer patients per month; 100 South Korean oncologists who treat at least 10 breast cancer patients and 5 non-small-cell lung cancer patients per month.