Hyderabad, India based NATCO Pharma Limited has entered into an exclusive agreement with Mabxience, the bio-similar division of Chemo Sa Lugano, Switzerland, an integrated healthcare multinational involved into different fields of pharmaceutical business, including biosimilars and branded pharmaceuticals.
Under the agreement, NATCO will purchase four mAb drug substances from Chemo and use the same for manufacturing finished dosage pharmaceutical formulations. Three of these products viz., Trastuzumab, Bevacizumab, Rituximab belong to the oncology segment, while Etanercept is for auto-immune disease. NATCO’s obligations under the agreement will include manufacture of drug products, undertake local clinical trials, filing registration of dossiers, to apply for market authorizations and to commercialize the product in India and a few other Asian countries.
Oncology is the largest therapy area within the mAb market, with eight marketed products. The mAb market is highly innovative and a key trend has been the move from murine to humanized and fully human antibodies, with insignificant generic presence..
World-wide, the market for mAbs has grown rapidly and is currently at a revenue level of around US $ 35 Billion.
With the product combinations chosen by NATCO, the mAb initiative is likely to be completed in a period of 24 to 36 months.
Editor’s comment: Natco is an another Indian company to enter the biosimilar mAbs area. As their market area is mainly India and some Asian countries, even bevacizumab (Roche/Genentech’s Avastin) which enjoys the patent protection in the EU/US are in the center of their point of interest. With this collaboration, we can see the first bevacizumab biosimilar in the world.
Source: Natco press release