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Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market
Date:4/7/2008

single-dose, randomised, double-blind, two-way crossover trial and used an active control. The trial involved 36 patients and was carried out by Prof. Bernd Jilma, MD, of the Medical University of Vienna (Department of Clinical Pharmacology).

The trial confirms data from the Indian market, where Neukine has been approved for therapy since 2004. Mani Iyer, Director IBPL, explains: "Over 3,000 cancer patients have already been treated with Neukine in India. No severe adverse reactions were reported, other than those commonly associated with Filgrastim. We are very confident that our joint clinical trials with Kwizda Pharma will demonstrate the quality of Neukine to the European authorities."

Logistics & Products

IBPL operates an EMEA-certified manufacturing facility in India since March 2007 and is now due to launch its products on the European market. As part of its business strategy, IBPL is working with Kwizda Pharma, which is helping to secure EU approval and will provide support with marketing logistics. Kwizda Pharma (established 1853), which has a well-established clinical background and extensive experience with regulatory procedures, is now offering its expertise to companies that manufacture biosimilar products, particularly those based in India.

Dr. Richard A Kwizda on the future prospects of this approach: "India has an excellent R&D basis and a skilled workforce, which makes its biosimilars attractive products for the European market. Our company supports Indian-based manufacturers of biosimilars to secure approval for the European market in a timely and cost-efficient manner."

About Kwizda GmbH

Kwizda GmbH is a privately owned group of companies and has been operating since 1853 (pharmaceutical division). Kwizda Pharma is a leading Austrian manufacturer and wholesaler of proprietary, in-licensed and third-party pharmaceuticals, OTC drugs and hospital infusions. In 2007, the company recorded sales of approximately
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SOURCE Kwizda Pharma GmbH
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