The Hindu Business Line : Patent for biosimilar drugs may be made mandatory

New Delhi, May 5 Indian pharmaceutical companies wanting to make cheaper copies of biopharmaceutical drugs may have to go through the patenting process before they can market the product. The Indian drug regulator is considering a proposal wherein generic versions of bio drugs, called biosimilars, may be mandated to apply for patents.

Biopharmaceutical drugs are medicines produced using a living system or genetically modified organism. Compared to traditional chemical medicines, even a minor change in the conditions, formulation or the processes can change the final product drastically.

Biosimilar medicines are supposed to be replicate versions of original biopharmaceutical medicines designed to treat the same diseases as the innovator’s product. However, compared to generic versions of chemistry based medicines, biosimilar medicines are extremely complex.

Complexities involved

Small changes in the manufacture of biopharmaceutical and biosimilar medicinal products can dramatically affect the safety and efficacy of the therapeutic molecule. “We are looking at this issue in detail. There is considerable debate surrounding the definition, licensing and marketing of biosimilar medicines. We may make patenting necessary for biosimilar products due to the complexities involved,” said a Government source, adding that a final view is yet to be taken. When contacted, Mr Tapan Ray, Director General, Organisation of Pharmaceutical Producers of India, said that stringent norms governing biosimilar drugs will be good for the consumers. “The very nature of a biologic means it is practically impossible for two different manufacturers to produce two identical biopharmaceuticals if identical host expression systems, processes and equivalent technologies are not used. This has to be demonstrated in an extensive comparability programme. Therefore, a generic biopharmaceutical cannot exist.”

Identity questions

Mr Ray said that biosimilar drugs cannot be identical to the innovator reference products, which means that substitution could have clinical consequences as patients could respond differently to the two products.

At present there are no clear Indian guidelines for the approval of biosimilars. Global biopharmaceutical market was estimated at $63 billion in 2005. The Indian Biotechnology industry is also gaining momentum, with revenues of over $2 billion in 2006, 70 per cent of which is biopharmaceuticals.

“This exploding scenario can put immense pressure on the government to facilitate the growth of biogenerics without stringently regulating the equivalence issues. This emphasises a need to establish guidelines for the approval of biogenerics in India, on the lines of regulated markets,” Mr Ray said.

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