Local pharma cos eye biogenerics market

By agencies   |   Tuesday, 18 October 2005, 07:00 Hrs
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MUMBAI: Biologicals are opening up a new avenue for domestic pharmaceutical companies that are seeking options beyond generics for global markets. A few big domestic companies are exploring the idea of diversifying their portfolios to include biogeneric products, a newspaper reported.

Among those that are considering launching biological products are companies like Ranbaxy Laboratories, Dr Reddy’s Labs and Zydus Cadila. Even domestic major Cipla is likely to explore this opportunity, the Economic Times said.

These companies have made applications to the Genetic Engineering Approval Committee (GEAC) for permission to manufacture and market recombinant human
insulin. According to the proposal submitted to the government, Ranbaxy and Cadila intend to procure the insulin crystals from Biocon. Cipla has applied for permission to conduct bio-equivalence studies of recombinant human insulin, also prepared using crystals from Biocon. Ranbaxy has also applied for permission to manufacture and market human granulocyte colony-stimulating factor (HGCSF).

Biocon and Wockhardt are the only two domestic manufacturers of recombinant human insulin, both bulk (insulin crystals) as well as formulation. These two companies have already taken early steps to tap the global market for biological products, the paper said.

One of the reasons why other companies are likely to follow suit is that the pipeline for potential generic launches is dwindling. On the other hand, a large number of biologicals are slated to go off patent. This will pave the way for competitors to legally manufacture biogeneric versions of these products and market them. Hence, the opportunity in the biogeneric space is likely to grow significantly over the next 10 years. Frost & Sullivan estimates that the biogenerics markets in Europe and the U.S. alone has the potential to generate sales of $16.4 billion by 2011 at an average annual growth rate of 69.8 percent.

The European Medicines Evaluation Agency (EMEA) recently issued guidelines for generic versions of some biopharmaceutical products such as insulin (for diabetes treatment) and erythropoietin (EPO), used to treat anaemia due to kidney ailments and cancer. These guidelines will permit Indian companies to apply for approval to market generic versions of biotech products in Europe, the paper said.

Biocon and Wockhardt have lined up a slew of products for the European market. Wockhardt plans to launch EPO and insulin initially, while Biocon plans to launch insulin, human growth hormone, GCSF, for which guidelines have been issued. Biocon is targeting all major European countries such as Germany, the UK, France, Spain, Italy, the Netherlands and Poland.

Industry watchers say it’s just a matter of time before regulations governing biogenerics are cleared in the U.S. market. Once the market for biogenerics opens up in the U.S., the Indian industry could be looking at a sizeable opportunity there as well, the paper said.

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