The top 10 diseases have shifted from communicable to non-communicable sicknesses such as strokes and asthma, thanks to the worldwide use of antibiotics and vaccines as well as improved living standard, an expert said Wednesday.
Medicine and technologies, particularly biotherapeutics and biosimilars, are expected to play a significant role in the treatment and care of many non-communicable diseases, which also include cancer and diabetes, he added.
|The International Symposium on Procedures and Data Requirements for Changes to Approved Biologicals is under way at the Sheraton Seoul Palace Gangnam Hotel, southern Seoul, on Wednesday.|
“Many countries in the Western Pacific have established regulatory biosimilar guidelines in the past decade and have registered biosimilar products for private sector distribution,” said Shin Jin-ho신진호, a medical officer at World Health Organization’s Western Pacific chapter. “However, there are many challenges and barriers for low- and middle-income countries.”
Shin made these and other points in an international symposium on “procedures and data requirements for changes to approved biologicals” held in Seoul.
Biotherapeutics, especially biosimilars, are now a significant growth area of the pharmaceutical industry worldwide. Biosimilar drug prices are 30 percent lower than the original drug and are improving access to treatments worldwide. However, low- and middle-income countries in the Western Pacific such as Samoa, Philippines, Vietnam, and Cambodia are struggling with the lack of universal health coverage.
“The barriers these countries face are due to weak government financing, feeble regulatory authority assuring the quality and safety of medicines, unreliable supply system, and low capacity of health technology assessment,” Shin said. “They also lack the accuracy of the burden of disease date due to the inefficiency of disease surveillance.”
Shin commented on the importance of national regulatory agencies (NRA) as an entry point toward achieving universal health coverage. The NRA is responsible for ensuring that products released for public distribution -- typically pharmaceuticals and biological products, such as vaccines -- are evaluated properly and meet international standards of quality and safety.
Critical control functions such as a published set of requirements for licensing, surveillance of vaccine field performance, regular inspections for good manufacturing practice, and evaluation of clinical performance can guarantee top vaccine quality.
Shin praised the Korean government which invested heavily in domestic biopharmaceutical companies by providing capital and administrative assistance, adding that a strong support system can go a long way to achieving universal health coverage.
According to the Korea Pharmaceutical Manufacturers Association, the biosimilar market Korea will grow to 150 billion won ($130 million) by 2019, nearly doubling in size from its 2013 value.
The legislative basis for the regulation of biosimilars and its guideline in Korea was established in 2009, co-developed by the World Health Organization guidelines and the Ministry Of Food And Drug Safety.
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