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Bio-similars and the a Everyday Men

Bio-similars are gaining popularity with ongoing various clinical research worldwide. What are Bio-similars ? And why the general consumers should care about them?
As explained by the FDA, a biosimilar is a biological product that is approved based on the fact that it is highly similar to an FDA-approved biological product. Biosimilars are like generics, which are drugs that are identical to a brand name drug in dosage form,strength,safety, way to administration, quality and intended use. But there is a difference between generics and biosimilars. It includes the complexity of the molecule, manufacturing and unlike generics, biosimilars are not the exact replicas of the reference drug. Hence, data required by regulatory agencies to prove similarities and obtain approval is more challenging.
The pharma sector is concerned about biosimilars because, as per BioPharm International, sales of biologics have gained from $20 billion in 2000 to $159 billion in 2014. As per reports, biologics represent about 70% of the worth of the top 10 selling drugs in the world. With an approximate 19% increase in sales across the global drug market over the last 14 years there is an expectation of continuous growth, biologics and biosimilars representing billions of dollars in revenue over the coming years. Forbes reported that the sector expects 10 of the top 20 global bestselling drugs in 2016 could be biologics.
That sounds great for pharma companies, but why should the average mankind care about biosimilars? Very simple: health and money matters.
Biosimilars have the power to save the healthcare system money because they are lesser in cost than the reference drugs. Moreover, Bio-similars have the ability to become a significant economic driver for the industry; as the Frost & Sullivan analysis predicts exponential growth over the next decade.
Biosimilars may also improve the outlook for patients since they have the potential to be significantly less expensive than their biologic counterparts, thereby making them more available to the people who require them like the elderly and the not-insured or under-insured. Biologics and their biosimilar counterparts are made used to treat a broad range of diseases including dermal conditions, cancer, low WBC counts, rheumatoid arthritis, anemia and many to mention.

The ramifications for clinical trials are vast as well. Biologics, by nature of their composition are large molecules and very complex products. Additionally, they’re extremely sensitive to the locations of where and how they’re produced. Fortune compares them to snowflakes, where the molecular makeup of each biosimilar treatment will appear unique, like individual snowflakes, even though they have similar results. This is how biosimilars are different than generics. You might have two biosimilars for the same drug with the same usage, but molecularly they will look different and may act unique.
Not every clinical research unit can carry out studies with biologics since they require high safety assessment capabilities, on site physicians to assess clinical trial volunteers daily and a rigorous quality control department.
You might or might not have heard very much about biosimilars before, but you could definitely expect to hear more and more about them in the coming times. With many of the leading biologic medications dropping off the patent cliff by 2020, the world will be seeing the benefits of biosimilars sooner as per assumptions.
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