Biocon Ltd has inked a deal with Novartis AG allowing the development of copycat biologic drugs made by a unit of the latter, Sandoz, by the former. This is the latest deal to be made by Biocon after a similar one with Mylan NV turned out to be a success.
In the partnership with Sandoz, Biocon will concentrate on the development of biolosimilars of biologic drugs used in oncology and immunology. Costs and profits will be shared equally by the two with Sandoz being granted the responsibility of commercializing the products in Europe and North America. Biocon will be responsible for the remaining parts of the world.
Due the fact that biologic drugs are made from substances found in living cells they are challenging to copy. With biosimilars being sold at lower prices compared to the branded counterparts, they are increasingly becoming important across the globe. Since developing and getting the approval of regulators with regards to biosimilars demands heavy investments especially in developed countries, Biocon has adopted a strategy of providing its manufacturing and development expertise to multinational drug makers willing to collaborate.
“This synergistic partnership will enable us to scale up our capabilities for an end-to-end play in the global biosimilars space. We remain committed to our mission of developing biopharmaceuticals that have the potential to benefit a billion patients across the globe,” said Kiran Mazumdar-Shaw, the managing director of Biocon, in a statement.
Fast-track review status
The deal between Biocon and Novartis comes in the wake of the latter being granted fast-track reviews in Europe and the United States for Kymriah, a cell therapy used in the treatment of blood cancers. Novartis has been seeking to broaden the patient pool that the costly treatment is can be prescribed for.
At the moment Kymriah has received approval for the treatment of B-cell acute lymphoblastic leukemia in young adults as well as children. The granting of the fast-track review status will allow it to get faster scrutiny from the United States’ Food and Drug Administration with regards to the treatment of refractory or relapsed diffuse large B-cell lymphoma in adults. In Europe the regulator gave Novartis an accelerated assessment status with regards to the use of Kymriah in treating young adults and children suffering from acute lymphoblastic leukemia.
With the priority review status accorded by the FDA decisions are made within a period of 180 days after the filing of an application. The accelerated review status in Europe sees a decision made within 150 days.