The Organisation of Pharmaceutical Producers of India (OPPI) has initiated efforts to gather views of the experts and recommend a possible regulatory pathway for approval of biologicals in India with the biotech industry in the country witnessing a boom time.

The Medical Committee of the OPPI recently organized a symposium on 'Biosimilars- regulatory pathway and public health' here, involving national and international experts and medical professions, as part of the attempt to suggest a regulatory pathway based on scientific and clinical experience in the interest of public health.

Prof. Dr. Rolf G. Werner and Dr. William Bennett, international experts in this area, presented papers at the symposium. Prof. Paul Declerck, Professor of Pharmaceutical Biotechnology at the University of Leuven, Belgium, an acknowledged expert in Biopharmaceuticals, dealt in detail with the requisites in the area.

"To ensure patient safety, the following should be prerequisites for granting biosimilar marketing authorization: a distinct brand name, an adapted Summary of Product Characteristics (SPC), sufficient clinical data and an adequate pharmacovigilance plan, he said.

According to latest industry reports, the biotech Industry in India has crossed a turnover of US$ 2b in 2006. Almost 70 per cent of this turnover is derived from biopharmaceuticals. In the recent past, biopharmaceutical drugs have out-performed the pharmaceutical market as they address the unmet therapeutic needs including many genetic diseases. They also command a premium price in the market, OPPI said.

"While the law allows introduction of generics after the patent expires, developing generic version of biopharmaceuticals is more complex than developing a generic copy of chemical based compounds through reverse engineering. This is one of the reasons why even in advanced countries like USA the regulatory pathway for approval of a biologic is not completely finalised, although EMEA (European Medicines Evaluation Agency) now has guidelines for approval of biologicals," a release said.

Indian Pharmaceutical Industry, which has achieved a position of distinction globally by achieving domestic sales of US $ 8b in addition to exports of US$ 5b in year 2006, is looking at this segment with a great interest. To illustrate the proliferation of biopharmaceuticals in India, the first Erythropoietin (EPO) in a pre-filled disposable syringe, was launched in this country in 1995 by Johnson & Johnson. EPO is used for treatment of anaemia due to chronic renal failure. Today, there are more than 18 EPOs in the Indian market. The story is more or less the same about several vaccines, insulin, etc.

"However, the most important aspect of a biological which is patient safety has not been given due consideration. Because biotech medicines are structurally very complex, difference in the cell line, manufacturing process and even changes in excipients and the surrounding environment can make major difference in the product's side effect such as immunogenicity and also efficacy. Substituting the biotech medicine with a generic version, therefore can raise serious health concerns," it said.