Hong Kong needs to formulate regulations for biosimilars

April 12, 2012 9:26 AM

Hong Kong, is one of two Special Administrative Regions (SAR) of the People’s Republic of China. A city-state situated on China’s south coast and enclosed by the Pearl River Delta and South China Sea, it is renowned for its expansive skyline and deep natural harbour.

With a land mass of 1,104 km2 (426 sq mi) and a population of seven million people, Hong Kong is one of the most densely populated areas in the world. As one of the world’s leading international financial centres, Hong Kong has a major capitalist service economy characterised by low taxation and free trade.

Among the widest range of healthcare services throughout the globe are on offer, and some of the SAR’s private hospitals are rightly considered to be among the very best of their type in the world. There are also strong public health systems in Hong Kong, and the Centre for Health Protection, founded after the SARS outbreak of 2003, is particularly worthy of mention.

Like elsewhere in the world, biosimilars are also a topic of discussion in Hong Kong. In a very recent article, which was published in  The Standard, health authorities have been urged to set guidelines for biosimilars to ensure drug safety.

“In comparison with chemical drugs that have been administered for years, the efficacy and safety of biosimilars are relatively less familiar to the pharmaceutical industry and the Hong Kong government,” said Vivian Lee Wing- yan, associate professor of the School of Pharmacy at the Chinese University of Hong Kong.

Unlike general chemical drugs, these medicines known as biologics are not composed of chemicals but are made up of molecules such as proteins, nucleic acids or complex combinations of these substances, or cells and tissues.

They are used for the treatment of rheumatoid diseases, cancer, diabetes and blood-related ailments, Lee said.

Several new-generation biologic medicines will come off-patent soon. The patents on at least one for rheumatoid arthritis treatment and two for cancer will expire in the next two to three years, she added.

Lee urged professionals in the industry and the government to jointly formulate regulations and guidelines for biosimilars. They should pay more attention to them because of the complexity in manufacturing and raise public awareness through education.

In addition, guidelines should be considered to monitor their efficacy and side-effects after registration.

“In the long run, a win-win situation can be achieved, with the medical system benefiting from the lower-priced biosimilars and comprehensive protection of the health of patients,” she said.


Sources: Wikipedia, The Standard Hong Kong

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