A biosimilar product for treating the negative effects that cancer
chemotherapy can have on the white blood cells of patients is safe and exhibits an identical pharmacokinetic and pharmacodynamic profile compared to a reference product. This is the result of a clinical phase I trial conducted jointly by the Austrian company Kwizda Pharma GmbH and the Indian manufacturer INTAS Biopharmaceuticals Ltd (IBPL). Upon completion of an upcoming clinical phase III trial, both companies will lodge an application to get the product approved for the European market. The market launch is planned for early 2010.
Neutropenia – a condition whereby the concentration of neutrophils (a type of white blood cell) in the blood is too low – is a serious side effect of cancer chemotherapy and can prevent the treatment from being successful.
Granulocyte colony stimulating factor (G-CSF) is a human protein that can reverse neutropenia by initiating the production of neutrophils. Recombinant forms of the protein have already been approved for the European market. However, due to the high costs that are involved, the relevant authority (EMEA) is encouraging applications for biosimilar products.
Working in partnership with IBPL, the first and only biopharmaceutical company in India to comply with EU Good Manufacturing Practice (GMP), Kwizda Pharma has now completed a clinical phase I trial as part of the European application process for a biosimilar form of recombinant G-CSF known as Neukine. Neukine exhibits identical efficacy to the EU-approved reference product.
Dr Helmut Brunar, VP of Research & Business Development at Kwizda Pharma, sums up the results of the trial: “Not only was Neukine cleared from the patients’ blood plasma just as quickly as the reference, but the number of neutrophils also increased with identical kinetics after treatment. We are very pleased with these results.”
The study was a 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.”
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.”