Researched through internet Market Risks Regulatory barriers in oncology trial procedures and compulsory licensing and patent revocation can pose to be threat to the cancer market. Increasing burden of launching new drugs, patent expiries of the drugs and pricing structure of expensive drugs are a threat to the competitors in a fragmented market. Costs involved in infrastruture and lack of support for requisite specialities and high gestation period for such projects form the major limitaiton for this project.
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 order, which raised questions on the processes followed by the Indian drug controller in approving such drugs, could also affect the availability and affordability of an expensive cancer treatment. Biocon Ltd, Asia's premier biopharmaceuticals company, has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India. Aug 25, · Since its the most prevalent cancer among Indian women, with approximately , new patients getting diagnosed every year in India, the originator drug costing around US$3,–US$4, (INR – lakh) for a month’s treatment, making it unaffordable to many of Indian citizens leading to lack of affordable treatment options for HER2.
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.Kiran Majumdar-Shaw, the CEO of Biocon has to make product launch timing, pricing, channel, and communications mix decisions relating to the launch of BioMAb, a new cancer drug in India.
Product. Nov 06, · Interestingly in one of the recent pharmaceutical lawsuits before Delhi High Court wherein Roche sued Indian pharmaceutical company Biocon and US based global generic Mylan for launching first biosimilar version of its original cancer drug "Herceptin" in India, one of the major contentions of Roche was that launch of "CANMAB" which was said to.
Hyderabad: Biocon Ltd will launch new branded formulations of its own and introduce products licensed from others to treat diabetes and cancer in the coming months, a top official at the bio. Biocon Limited, publicly listed in , (BSE code: , NSE Id: BIOCON, ISIN Id: INEG) is India's largest and fully-integrated, innovation-led biopharmaceutical company.
As an emerging global biopharmaceutical enterprise serving customers in over countries, it is committed to reduce therapy costs of chronic diseases like.
Biocon: Launching a new cancer drug in India Pros and Cons for Different Strategies Product Delaying the launch of BIOMAb to wait for 3rd phase results. • 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. Biocon Case Analysis. How About Make It Original? Let us edit for you at only $ to make it % original.