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An increasing number of biologics and biosimilar products are appearing in the Thai market, but there are challenges concerning IP protection and regulation, say Alan Adcock and Atthachai Homhuan of Tilleke & Gibbins.
In 2002, the Thai government initiated a universal scheme to bring equitable healthcare access to the general public. Under the scheme, hospitals receive per capita funding based on 47 million people. At the outset, funding was approximately $38 per person; now, it is $83. Although per capita funding has more than doubled, the current figure is still low. This budget constraint has led the Thai government to favour generic companies as opposed to originator companies.
The Thai Food and Drug Administration (FDA Thailand) defines a biological product as any allergen, antigen, vaccine, hormone, cytokine, enzyme, product derived from stem cells or tissues, human whole blood and plasma derivative, therapeutic serum, immunoglobulin, or monoclonal antibody which is obtained from one of the following procedures:
- Microbial or eukaryotic cells culture;
- Extraction of substances from biological tissues, including human, animal, and plant tissue;
- Recombinant DNA techniques;
- Hybridoma technique; or
- Propagation of microorganisms in embryos or animals.
FDA Thailand’s definition of a biological product is quite broad, ranging from the well-established structure molecule to cells and tissues. Most biological products have a relatively large molecular weight and are more complex than conventional chemical drugs.
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Alan Adcock, Atthachai Homhuan, Tilleke & Gibbins, Thai Food and Drug Administration, biologics, biosimilar, patent, Thai Patent Act, MA licences,