Biopharmaceuticals

Biopharmaceuticals the term ‘Pharmaceutical’ indicates any drug or medicine used for medical purposes. The pharmaceuticals that are obtained from biological sources are termed Biopharmaceuticals or biologics. However, some biotechnologists make a difference between biopharmaceuticals and biologics based on the methods employed to manufacture them. According to them, those products obtained from biological sources using biotechnological principles and procedures such as rDNA technology, gene cloning technology, gene mutation technology, hybridoma technology, fermentation technology, etc, are biopharmaceuticals. In comparison, those products obtained from native biological sources without employing any such engineering principles and techniques except simple extraction, centrifugation processes, etc., are usually termed biologics. However, since biopharmaceuticals and biologics are obtained from biological sources, these are synonymous terms and are grouped as the same products by many biotechnologists. Biopharmaceuticals or biologics are biotechnology products, biotech medicines, and biotherapeutics.

Biopharmaceuticals include recombinant proteins or peptides (eg, interferons, interleukins, hematopoietic growth factors, hormones, etc), monoclonal antibodies, and nucleic acids (gene therapy and antisense therapy), antiserum, vaccines, blood products, etc. Biopharmaceuticals are used for therapeutic or in vivo diagnostic purposes. Insulin was the first FDA-approved biopharmaceutical developed by Genentech using recombinant DNA Technology but licensed to Eli Lilly and Company. They manufactured and marketed the product in 1982 in the name of Humulin® (recombinant human insulin).

Since biopharmaceuticals are very complex molecules in structure and expressed or produced by a living system, it is impossible to replicate in the same manner as pharmaceuticals or traditional drug molecules. Even from the same manufacturer, biopharmaceutical products of two different batches will not be the same. For these reasons, a version of an innovator's biopharmaceuticals may not be appropriately termed as ‘generic’ as used for traditional pharmaceuticals or drugs. [Md. Abdul Mazid]