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Detailed market examination under way

Mr Habil Khorakiwala

G. Naga Sridhar

Hyderabad, July 9 Pharmaceutical and biotech major Wockhardt Ltd is gearing up to launch its insulin in the US and European markets as the regulation for biogenerics (or biosimilars) is likely to be in place in these regions soon.

“We will be filing for approvals in the insulin segment in the US and Europe soon. Currently, a detailed market examination is under way in the light of extremely positive signals from the US Senate on the generic biotech drugs’ front,” Mr Habil F. Korakiwala, Chairman, Wockhardt Ltd, told Business Line here.

The company, which has been active in biopharmaceuticals, currently has Wosulin (recombinant insulin) in the Indian market in addition to Biovac-B (hepatitis B vaccine), and Wepox (erythropoietin).

Wosulin is the first r-DNA insulin developed and manufactured outside the US and Europe through the latest yeast based expression system.

While Biovac-B is a WHO GMP certified hepatitis B vaccine, Wepox has been created by mammalian cell culture and meets European Pharmacopoeia standards for the treatment of anaemia caused by cancer and chronic renal failure.

“Though we are equally strong in other segments, for time being insulin will be our first product for the US and Europe. It may take 18 months for approvals once the regulation is in place and we expect to see our insulin there by early 2009,” Mr Korakiwala said.

On Wockhardt’s expectations on the US market, he said: “In the biotech field, the US market is three times larger than that of Europe. It is a multi-billon dollar market and we are very positive about it. The things were moving in the right direction as the work to be done for clearing European regulations is nearly similar to those in the US.”

Europe and US together account for over half of Wockhardt’s sales (The total sales stood at Rs 523 crore in the first quarter ended March 31, 2007).

“We look forward to a great opportunity in biogenerics in the US and Europe,” Mr Korakiwala said.

The company had “nearly completed” the development of Glargine (a novel long-acting insulin) for Indian market, he added.

According to reports, a US Senate panel voted on June 27 to set a path for generic drug makers to seek approval for cheaper, copycat versions of expensive biotechnology medicines.

Brand-name manufacturers would receive 12 years of exclusive marketing time before generic competition could start under a bill that was cleared by the Senate Health, Education, Labour and Pensions Committee.

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