Biosimilar is a fastgrowing field and the global revenues for biosimilars are expected to cross 20 Billion USD by 2020. A biosimilar molecule is manufactured in a different clone and processes, than the innovator and yet has to match the innovator in terms of all critical quality attributes. Hence, in many ways CMC development of biosimilars is more challenging than development of Novel Biologics.
Enzene has build technical expertise in terms of talent and infrastructure, which will allow us to access the biosimilar market. We have fully integrated R&D set up with capabilities including cloning, process development and novel formulation development.
As innovation remains the core of our company, we have adopted many technologies from clone to clinic to make our products cost effectively. One such latest implementation is developing a continuous way of manufacturing for our biosimilars. The volumetric productivities for continuous process are much higher compared to the traditional Fed-Batch processes. This will result in huge cost reduction in terms of process and manufacturing set up. The controls on product quality are much better and issues related to largescale up can be minimized.
Enzene has a strong pipeline for therapeutic product development with over 8 products in various stages of development, which includes recombinant proteins and monoclonal antibodies. Enzene's core team has several years of experience working in both industry and academia at national and international level to develop cost effective therapeutics. The team has hands-on experience developing and launching biosimilars in India, Europe and USA. The team comprises of graduates, postgraduates and doctorates in the field of life sciences and chemical sciences. The vastly experienced strategic team helps us in identifying niche technology platforms, business focus, and research partnerships.
Domestic product development:
We have a very strong domestic product pipeline, which includes therapeutic recombinant proteins and monoclonal antibodies. We are in advanced stage of clinical development for 6 molecules that have passed pre-clinical testing and extensive bio similarity has been established with the reference standard. These clinical programs will be initiated in the coming year.
Global product development:
From our product pipeline, we have selected molecules that we are developing for global submission. One recombinant molecule and one monoclonal antibody are already in developmental pipeline. We have engaged FDA and EMA for the strategic development of these molecules.