Difference between Biologics and Biosimilar Drugs
Most medicines can be divided into two broad categories viz. drugs and biologics. The drugs are small-molecule chemical compounds, quite simple in their structure. They are synthesized from chemicals; and have the same effect all the time. The common examples of drugs include: Paracetamol, Acetaminophen (Aspirin), etc.
Biologics on the other hand, are large and complex (200-1000 times bigger than drugs) molecules, prepared within the living cells {such as engineered bacteria}. Since they are prepared in living cells, they are less stable in comparison to the drugs and need special storage and handling process. Examples of biologics include various types of therapeutic proteins {for example Serum Albumin, antibodies etc.}.
Though the preparation of biologics on commercial scale is a complex and costly affair; they have revolutionised the treatment of chronic illnesses such as cancer, neurological disorders, rheumatoid arthritis and so on. They are most expensive medicines on earth and are also top selling medicines. Since biologics are created in living cells, there is no guarantee that two doses of such medicines will be identical; because minor changes keep coming due to cell errors.
Biosimilars
When the patents of Biologics is no longer in force, many companies resort to release similar biologics with the approval of and with due credit to the original creator of these medicines. Such medicines have same chemical recipe, have the same effects but bring down the cost heavily. Such follow-on biologics are called Biosimilar. At molecular level, Biosimilar is almost same as Biologics. Their key advantage is cost.
Biosimilars can be called generic version of the Biologics, however, this is not technically correct because Biosimilars are not exactly like original drug.
Biosimilar Industry
Biosimilar industry is among the fastest growing industries in global healthcare segment. The launch of first Biosimilar drug was approved by EU in 2006. In March, 2015, the US FDA gave approval to first Biosimilar product in that country. With this, there has been a competition among the Pharma companies including Indian companies to exploit the market.
In India, many companies such as Biocon, DRL, Zydus Cadilla, Wockhardt etc. are active in Biosimilar market. But still, doctors are reluctant to prescribe Biosimilar because they are priced near to the original biologics. Cost is the key for this sector and if there are correct pricing policies, Biosimilar market can emerge as another growth driver {after generics} for India’s pharmaceutical exports.
