Pilot plant to check biosimilar products

Pilot plant to check biosimilar products

The National Centre of Genetic Engineering and Biotechnology (Biotec) is working with King Mongkut University of Technology Thonburi to set up a pilot plant to conduct production tests for biosimilar medicine products.

Published on November 6, 2007

Biotechnology researchers could bring their research projects related to the development of biosimilar medicines into real production at the plant, said Biotec's director Morakot Tanticharoen.

Biosimilar medicines are follow-on versions of original generic medicines.

They are independently developed after the patent protecting the original product has expired.

Morakot said biosimilar medicines would be an alternative for the country to produce its own medicines at a lower cost. However, research and development to find new processes to develop the medicines - which had to have the same mechanism of action as the original medicines - was required.

To reduce import substitution of drugs, she said the country should push research and development of biosimilar medicines so technology to produce drugs at a lower cost should be available.

"We should encourage local researchers to conduct research and development projects to find a new manufacturing process to produce drugs for which the patent is coming close to expiry," she said.

Many countries such as India are now putting strong efforts into biosimilar medicine research as they see this as a way to help their country reduce drug prices for their people, and if successful they also have a chance to produce lower-cost drugs for export.

Morakot said that in India researchers surveyed for drugs for which the patent was soon to expire and then began to research new methods to produce the drugs by using biotechnology to bring the production cost down. Once the patent expires, they have a technique to immediately produce the drug.

Morakot said there was also a group of biotechnology researchers conducting biosimilar medicine research in Thailand. Their projects could have market potential, he said. "There should be a place to allow them to test practical production of their products."

The idea was raised two years ago among biotechnology researchers and it has recently been approved by the National Science and Technology Development Agency.

The establishment of the pilot plant is expected to cost around Bt300 million to Bt400 million. As the plant will be built at KMUTT, the university will also take care of the construction and the budget.

Morakot said Biotec would oversee the training of personnel in biosimilar medicine as well as providing tools and facilities for research.

She said that as the plant would offer test runs for real production of biosimilar medicine products, it would be built under Good Manufacturing Practise standards.

"The plant will be key infrastructure for biosimilar research as it will help researchers test the production of their products to evaluate the possibility of producing the drugs for commercial use," she said.

Potential products from biosimilar technology include human growth hormones and vaccines.

Pongpen Sutharoj

The Nation