LinkedIn Biocon Limited has faced significant price pressures from their source of business revenue, consisting mainly in the manufacture of active pharmaceutical ingredients API. To combat this commoditization, Biocon management chose a strategy of innovation. This new strategy was the licensing and development of molecules tested strategic partners jumping competition and create large biological molecules in India. The company is aware that the transition from an API to a society based on the focus on the innovation of new biologicals, patience and a risk-taking mentality is needed.
However after several months of deliberation and debates, the Department of Industrial Policy and Promotion DIPP refused a plea for compulsory licensing for Trastuzumab. Also, last year in a very surprising development Roche decided not to pursue Herceptin patents in India.
But inspite of all the pricing advantage, ex parte proceedings by Roche at the Delhi High Court last week has led to an injunction stopping two pharmaceutical companies i.
In view of the structural and manufacturing complexities involved in the production of the biopharmaceuticals, a biosimilar product can only be similar to the innovator biopharmaceutical product; it cannot be a generic equivalent of the innovator biopharmaceutical product.
Also, with the development and growth of the market for biosimilars in India and the international standards for approval of such products, the Guidelines on Similar Biologics were issued in which lay down specific standard for development and evaluation of similar biosimilar biologics.
After the issuance of the Guidelines on Similar Biologics, all the applications for manufacturing and marketing authorization of similar biologics in India are required to be evaluated on the basis of the standards set forth on it ie; the demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic.
The Swiss company argues that there is no public record available, in the clinical trial registry India CTRI or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug. With respect to the human safety, there is a very big question which highlights the negligence of the drug controller who gave an approval to Biocon and its partner Mylan without the necessary clinical trials being conducted.Biotech major Biocon has launched CANMab (biosimilar Trastuzumab) for treating breast cancer in the Indian market from next month.
The company has priced the drug 25 per cent lower than the market lea. Biocon: Launching a New Cancer Drug in India Case Solution,Biocon: Launching a New Cancer Drug in India Case Analysis, Biocon: Launching a New Cancer Drug in India Case Study Solution, Kiran Majumdar-Shaw, CEO of Biocon to do product launch dates, prices, channels and communications mix decisions related to the launch BioMAb, a .
• Head and Neck cancer is one of the most prevalent forms of cancer in India, accounting for 28% of cancer incidences and 26% of total deaths. Biocon may look at launching the drug in other countries in Asia and Africa.
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Biotechnology company Biocon on Saturday launched a new and cheaper drug to treat 'metastatic' breast cancer that aggressively spreads to other parts of the body. Biocon which developed the drug in association with US drugmaker Mylan received the approval for CANMab, the biosimilar version of anti.
Biocon gears up to launch new drugs to treat diabetes, cancer BY VISWANATHPILLA [email protected] HYDERABAD iocon Ltd will launch new branded formula- live in India. Biocon also expects launches of two key biosimi- lars, bevacizumab and adali- mumab, in India in the near future, Subramanian said.
Earlier, the court had blocked Reliance Life Sciences from launching a copy of the Swiss company's drug, while Biocon and Mylan's products are available in the market.