Biosimilar peptides: need for pharmacovigilance

Abstract

Biosimilars or their copies are generic version of biopharmaceutical medicines which try to mimic products which are derived from recombinant technology. These are near or semi-identical products which use a separate process for its bioformulation and need to pass strict mandates of regulatory bodies like U.S. FDA and EMEA in Europe. As these compounds need for the process of manufacture requiring fermentation and not traditional reverse chemistry it is difficult to mimic bioidentical compounds. There are clear cut differences in the manufacture process and protein folding. However there is unclear data currently to know if these biosimilar have any clinically relevant impact. Due to the sophisticated nature of these biomolecules and their 3-D structure its a new area of research for pharmaceutical scientists and drug regulators. In India apart from Biogenerics a host of molecules especially have Biosimilar copies of compounds especially in endocrinology namely insulin, Exenatide, growth hormone, teriperatide like peptides are made in India. These need evidence based validation if they have clinically relevants effects or side effects and close pharmacovigliance.