Biologics are therapeutic agents or analogs, mostly consisting of proteins and other products (monoclonal antibodies and hormones) derived from living organisms for the treatment
or management of disease or injuries.
A biologic is a prophylactic, an in vivo diagnostic, or a therapeutic substance that:
- is produced only by a living system, but is not simply a metabolite
- is stated to contain a single substance that has documented biological activity or activities
- has a relatively large molecular weight with a high structural complexity compared with biologically active substances that can be made by chemical synthesis (in practice, this means that biologics will seldom have molecular weights less than 5 kDa)
- is inherently heterogeneous in the molecular species present and has an impurity profile that depends critically upon the processes used to make and test each batch
- has activity that is often very sensitive to physical conditions (temperature, shear forces, phase) and enzymatic action
- Usually requires bioassays for batch release and stability assessment, rather than chemical tests for identity and purity.
Recombinant therapeutic products: Recombinant DNA technology has made a revolutionary impact in the area of healthcare by enabling mass production of safe, pure and more effective versions of various biochemicals used as therapeutics.
It has helped in the production of new therapeutics as well as safer and/or effective versions of conventionally produced therapeutics.
The biopharmaceutical industry in India started with developing the generic version of the approved biopharmaceuticals, which have sizeable sales in the world.
These are called as biogenerics. All the above products have been developed and commercialized by different Indian companies.
The regulatory requirement in India for the approval of the therapeutic proteins was for a bridging clinical trials and a limited pre-clinical testing. The Indian biopharmaceutical companies, however, will find it difficult to use a similar approach for the other recombinant therapeutic products and monoclonal antibodies which have been patented in India after 1995 because of changes in the patent laws. The options left for the Indian industry are:
a) To identify new targets and develop therapeutic molecules against them after extensive research. This involves long time frames and extensive investments in research and development. Shantha biotech developing therapeutic antibodies against lung cancer is an example of this strategy
b) To license the molecules patented post 1995 from biopharmaceutical companies around the world and market them in India. This is the case with Nicolas Piramal marketing some of the monoclonal antibodies
c) To collaborate with innovator companies for those molecules that are in different stages of development. The Indian companies can contribute to the co-development of these molecules in the areas of process development, manufacturing, preclinical testing and clinical trials. Biocon Limited collaborating with CIMAB of Cuba for the developing the HR-3 humanized antibody against epidermal growth factor receptor is an example of this type of development.
Thus the development of biopharmaceutical molecules in India has seen the trend of developing the biogeneric versions of blockbuster drugs in the early 2000 followed by collaborative development and/or indigenous development of new molecules.
- The author is Scientific Manager, Biocon Limited