Natco is a speciality pharmaceutical company headquartered in Hyderabad, India. It is a leader in the oncology segment in India. Apart from branded generics, Natco is involved in discovery, research and development which includes novel drug delivery systems.

Under the agreement, Natco will purchase four monoclonal antibody (mAb) biosimilars from Chemo Sa Lugano and use them for manufacturing finished dosage pharma formulations. Three of these products, Bevacizumab, Rituximab and Trastuzumab, are cancer treatments, while Etanercept is used for auto-immune disorders.

Biosimilars are structural imitations of the originator, promising the same effect as originator biologicals, but at a reduced price. Given the fact that annual treatment costs for patented biologicals can run into the tens of thousands of dollars [2], biosimilars represent an important alternative for both patients and payers.

Natco’s responsibility under the agreement will include manufacturing of drug products, undertaking local clinical trials, filing registration of dossiers, applying for market authorisations and commercialising the biosimilars in India and a few other Asian countries.

Oncology is the largest therapy area within the mAb market, with eight marketed products. Worldwide, the market for mAbs has grown rapidly and Natco estimates sales to be currently around US$35 billion.

Natco expects to market the finished biosimilars within 24 to 36 months.

India is seen as being an area of major opportunity for biosimilar manufacturers [3]. In India there are no market and data exclusivity provisions to protect originator drugs and cost reductions for manufacturing of around 40% have been suggested [4]. The Indian government has also been actively encouraging biosimilar development by investment in government-led initiatives and by constructing biotechnology parks [5].

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References

1. GaBI Online - Generics and Biosimilars Initiative. Mylan re-brands Matrix Labs to enter Indian market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 10]. Available from:www.gabionline.net/Biosimilars/News/Mylan-re-brands-Matrix-Labs-to-enter-Indian-market

2. GaBI Online - Generics and Biosimilars Initiative. Hurdles to entering the biosimilars’ market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 10]. Available from:www.gabionline.net/Biosimilars/General/Hurdles-to-entering-the-biosimilars-market

3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars or biobetters – what does the future hold [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 10]. Available from:www.gabionline.net/Biosimilars/Research/Biosimilars-or-biobetters-what-does-the-future-hold

4. Strategic analysis of Indian biosimilar market. Frost & Sullivan Research Service. 2011 May 10.

5. GaBI Online - Generics and Biosimilars Initiative. Indian government encourages biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 10]. Available from: www.gabionline.net/Policies-Legislation/Indian-government-encourages-biosimilars