What Is the Difference Between Biologics And Biosimilars?
Biologics
Biologics are medicine
derived from living cells and constituents of human bodies like Ribo
Nucleic Acid (RNA), Deoxyribo Nucleic Acid (DNA), or hormones.
The first biologic developed for therapeutic use was insulin. Currently, biologics
have become the fastest growing drugs in the Pharmaceutical Industry with
around 300 biologics available for human consumption.
Biologics are widely used
to treat a vast number of diseases including cancer and rheumatoid arthritis.
They are better in targeting cancer producing cells due to its efficient
binding nature. The Pharma Companies estimate that by the year 2019, sales of
biologics would generate a revenue of approximately USD220 billion annually.
However, only a small fraction of biologics, especially the monoclonal
antibodies (mAbs) is going to create most of this revenue.
Entry of Biosimilar in Pharmaceutical Industry
Biosimilar, as the name
suggests, are “highly similar” to one of the FDA-approved biological product
which the scientist terms as the reference product. Currently, Biosimilar
Manufacturing has become very
important in Pharmaceutical Industries as the U.S. Law now approves the
biosimilars, which show very similar therapeutic activity to the biologic
reference product. The significant advantage of Biosimilar Manufacturing process
is it is a highly cost-effective procedure than the production of biologics.
Difference between Biologics and Biosimilars
Let us now understand the
difference between the biologics and biosimilar drugs concerning the cost of
production briefly.
· Cost of Production
One of the
significant challenges affecting the biologic drug production is the high cost
of production of these drugs. The hefty sum spent on research and development,
complex testing and manufacturing
process makes the production of biologics a costly affair. On the other hand,
since the biosimilar does not have to go through the entire research and
development process, can be made available to the patients at a fraction of the
cost of biologic drugs.
Generally, the biologics hold a
patent for 15-20 years. After this, the Pharmaceutical
Companies can develop a biosimilar drug paying a license fee to the originator
companies. In this way, the cost of Biosimilar Manufacturing can come down
significantly. In 2010, the United States Congress approved the Biologics
Price Competition and Innovation Act (BPCIA), which paved the way for the
introduction of biosimilar drugs in the market. In March 2015, the U.S.
Food and Drug Administration (FDA) for the first time approved a biosimilar
drug, Zarxio (a biosimilar to Neupogen) for use by cancer patients. In April
2016, Inflectra (a biosimilar to Remicade) is the second biosimilar drug
introduced in the market for treating Crohn’s Disease and different forms
of arthritis.
So, the cost of production
is the main point of difference between the biologics and biosimilar drugs.
When it comes to Biosimilar Manufacturing, Kemwell Biopharma is the name most of the doctors,
and other eminent Pharmaceutical Companies rely on. It is the best Biopharma
Company regarding state-of-the-art
plant and comprehensive drug manufacturing process.
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