Biologics/ Biological products

Biologics are very complex and large molecules. Constituents of biologics can include sugars, proteins, or nucleic acids or complex combinations of these substances, or living entities such as cells and tissues.

They are produced from various natural sources (human, animal, or microorganism) using biotechnology methods and other cutting-edge technologies. Recombinant DNA (rDNA) is one of the important processes for producing biologics.

Biologics are used to treat, prevent or cure a disease or a condition of human body. The therapeutic target of a biologic is always a gene or a protein.

Biologics may provide the promising means to treat various medical conditions which are having no other treatments available. For example, gene-based and cellular biologics are useful to treat a number of medical conditions for which no other treatments are available.

It is difficult or sometimes impossible to characterize a biologic due to its complex nature. The biologics can be very sensitive to very minor changes in its complex manufacturing process. Small process differences can significantly affect the nature of the finished biological product and the way it functions in the body. Hence, it is Important for the manufacturer to take detailed care of each step of the manufacturing process. Manufacturers must make certain that the manufacturing process is considerably same over the period of time in order to maintain the quality, purity and consistency of the product. The final product quality is tested in clinical trials.

Biologics are very expensive because of the involvement of complex research and development of unique and suitable manufacturing processes. Each biologic has unique process controls. Developing finished and fully functional biologic is a difficult work and the innovator carries an intimate knowledge and experience regarding the whole process. Hence, innovator of biologics looks for more patent protection.

Due to particular processes, it would be difficult or impossible for another manufacturer to make the "same" biologic without the same knowledge and experience of the process.

Differences between Biologics and Pharmaceuticals

Biologics are different from pharmaceutical drugs. Unlike biologics, a pharmaceutical drug is manufactured through synthesis of chemicals in a predefined and orderly process. Similarly, there are many differences between biologics and pharmaceutical drugs. They vary in different aspects such as method of manufacture/synthesis, structure, routes of administration, etc. A summary of these differences is listed below.