When we read Pharmaceuticals, the initial term that comes to our mind is ‘drugs’. And of course Pharmaceuticals as a build-up infrastructure for manufacturing makes drugs as medicines only. As per the Food and Drug Administration (FDA) organization there are more than 32,000 approved generic drugs in the global market. Licensed generic drugs are sold over the counter (OTC) in a pharmacy based on physician’s prescription. Some examples of OTC drugs are such as aspirin e.g. Paracetamol (fever), Combiflam (for fever & as a pain killer) etc., anti-histamine e.g. Citrezin, Allegra etc. or antibiotics e.g. penicillin, amoxicillin (bacterial and fungal infection) etc.
Apart from the generic medicines we have biologics, these are most appropriately considered as lifesaving drugs since these have been a flair out of the scientific research in the fight against genetic diseases such as hypertension, diabetes etc., cancer e.g. breast cancer, prostate cancer, ovary cancer etc. , autoimmune diseases such as rheumatoid arthritis, sexually transmitted diseases e.g. AIDS, HPV etc.
Biologics are not the same as generic medicines based on the production. Generic medicines has active compound (molecules) that is produced via chain of complex chemical reactions in lab/industry but biologics are made from the cells, used as tissues, contain components of cells, blood components so these are macromolecules much complex and bigger than the drugs. There are over 620 licensed biologic as medicines in market this includes vaccines such Hepatitis-B, Yellow fever, CoVAXIN (CoVID-19) etc., monoclonal antibodies e.g. Herceptin, Avastin etc., hormones e.g. insulin, progesterone, vitamin-D etc., immune modulator e.g. abatacept & others. The process of manufacturing of the generic drugs and biologics are not the same as generic drugs are known to be manufactured in bulk but this is not the same for the biologics nevertheless the demand of biologics are increasing but since the use of cutting edge technology in making of the biologics so it make it deem for biopharmaceuticals to have reliable and agile forecast predicting the demand in the market in coming years.
There is a term as Biosimilars being used quite these days, this should not be confused with the term biologics. The biosimilars drug has a reference drug which is the biological medicine. Biosimilar mimics the biological medication/Biologics with a certain difference in the overall structure of the active macromolecule (proteins) so it is clear that we cannot replace the word as biosimilars with biologics.
In much simpler way we can say that ‘Generic drugs are manufactured in Pharmaceuticals and Biological medicines are manufactured in Bio-pharmaceuticals.’ Indeed the Pharmaceuticals industry is not the same as Bio-pharmaceutical industry and the major difference lies in the approach of manufacturing the medicine. Bio-pharmaceutical industry would cost much times than Pharmaceutical industry since this former is based on the biotechnology that involves use of cutting edge technology for producing lifesaving drugs.
Be it a pharmaceutical or bio-pharmaceutical, both are regulated by the FDA, US. And it is mandatory for both kinds of manufacturing companies to follow the current Good manufacturing practices (cGMP) inprocess of getting certified from USFDA. Presently, most of the drug making companies are following the Good manufacturing practices yet the drugs produced in these pharma companies are considered as ‘adulterated’ by USFDA unless they meet cGMP.
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