Navigation Links
Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market

VIENNA, Austria, April 7 /PRNewswire/ -- 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.

Similar & Identical

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."

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 EUR 50 million.

About IBPL

INTAS Biopharmaceuticals Limited is one of the fastest growing biopharmaceutical companies in India. As an independent biopharmaceutical company of the INTAS Group, it has carved a niche in the biotechnology sector in the country. The company has fully integrated biopharmaceutical operations with an ultra modern R&D facility and an EU GMP-certified manufacturing facility.


Kwizda Pharma GmbH

Helmut Brunar, Ph.D., M.Sc.

VP Research & Business Development

Effingergasse 21

1160 Wien


T +43-664-822-57-60



IBPL - INTAS Biopharmaceuticals Limited

Plot No. 423/P/A/GIDC

Sarkhej Bavla Highway





Copy Editing & Distribution:

PR&D - Public Relations for Research & Education

Campus Vienna Biocenter 2

1030 Vienna, Austria

T +43-1-505-70-44



SOURCE Kwizda Pharma GmbH
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
2. MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate
3. Increasing Dairy Milk Production with Electrolyzed Drinking Water
4. Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development
5. Ception Therapeutics Initiates Phase II/III Clinical Trial for Its Lead Product Reslizumab in Eosinophilic Esophagitis (EE) in Children
6. ATS Medical Announces Initial Clinical Results of Stand-Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line
7. On Second Anniversary, Compendia Bioscience Announces Significant Revenue Growth, Completion of Product Milestone and Expansion of Pharma Customer Commitments
8. Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candidate HZT-501
9. Data Demonstrate that Obagi Medical Products Condition & Enhance Skin Care System is an Effective Complement to Facial Rejuvenation Procedures
10. Surgex(TM) Becomes the First and Only BSCG (Banned Substance Control Group) Certified Product Which is Clinically Proven Effective in Sports Recovery and Performance
11. IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival
Post Your Comments:
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... the "Advanced Wound Care Market by Type (Dressings, ... End User (In-Patient Facility, Out-Patient Facility), and Geography - ... --> --> ... description, definition and forecast of the global advanced wound ...
(Date:11/26/2015)... ) has announced ... High Viscosity Drugs" report to their offering. ... addition of the "Self Administration of High ... --> Research and Markets ( ) ... Administration of High Viscosity Drugs" report to ...
Breaking Medicine Technology:
(Date:11/29/2015)... , ... November 29, 2015 , ... Khanna Vision Institute ... Board of Ophthalmology on November 25th 2015. Peer Certification by the Board is ... his specialty. Certification in Ophthalmology is first obtained after the completion of three years ...
(Date:11/29/2015)... IL (PRWEB) , ... November 29, 2015 , ... Effective ... In addition starting on Black Friday Target is offering a “Buy One ... This is a rare opportunity to purchase IguanaMed at a discounted price. ...
(Date:11/28/2015)... ... November 28, 2015 , ... Trying to relax on ... the COUCH BUDDY. "I conceived of this design due to personal experience with a ... users. It promotes relaxation and convenience, as well as increases support. It also makes ...
(Date:11/27/2015)... Los Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... the conversation at the recent 2015 American Dental Association meeting in Washington D.C. revolved ... can help protect a patient’s overall health. The talk stressed the link between periodontal ...
(Date:11/27/2015)... , ... November 27, 2015 , ... A team of ... ways to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Hospital Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy ...
Breaking Medicine News(10 mins):