Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

What are Biosimilars?


From UPSC perspective, the following things are important :

Prelims level: Biosimilars

Mains level: Paper 3- What are the bio-similar molecules and their applications in the pharma sector?

Recently an Indian pharma company has been granted a USFDA approval for Insulin Glargine, a biosimilar. This article briefly introduces us to this term, complexities involved in its manufacturing and also explains why the USFDA approval create hype.

The story of simple molecules and some difficult diseases

  • Ever since modern medicine started to emerge post the Industrial Revolution, simple molecules have been used to treat most diseases.
  • While these formulations are highly effective against some illnesses, they aren’t particularly effective against more complex diseases like cancer.
  • Our immune system has evolved over millions of years to specifically defend against outside intruders.
  • But cancer isn’t like most diseases.
  • It’s not caused by an invasion of a foreign pathogen.
  • Instead, it’s a byproduct of rogue cells that destroy our bodies from within.
  • To this end, using simple molecules to defend against a barrage of mutating versions of our own cells is an exercise in futility.

What is biologic?

  • A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.
  • What we probably need is a biologic or a complex protein isolated from natural sources that can mimic our immune cells.
  • Maybe this would help us in fighting cancer.

So, Biosimilars are..

  • A biosimilar is a biological product that is developed to be similar to an already FDA-approved biologic, known as the reference product. It can be tempting to think of a biosimilar as a “generic” version of the reference product.
  • But biosimilar is not an exact duplicate of another biologic. There is a degree of natural variability in all biological products; it is not possible to generate a precise copy of a product that comes from living cells. All biologics—including reference products—show some batch-to-batch variation.

Utility of patents in the pharmaceutical industry

  • Success in this market is deeply intertwined with the research and development process that characterizes the pharmaceutical industry.
  • It might take 5 years for you to develop a new drug and you might still need another 10 years to clinically test the product and get the necessary approvals from the regulatory agencies.
  • This is a capital intensive process and the only way to remunerate the pharma company’s contribution is to protect their investment through patent laws.
  • This way the companies can be incentivised to invest more in research and we can ensure a steady supply of new drugs that could cure the greatest maladies of modern time.

What happens when the patent expires?

  • Once the patent expires, other companies can market their own version of the drug (copycats) if they can figure out how to synthesize it.
  • Consider — Aspirin. It’s a simple molecule drug and it’s quite easy to replicate the manufacturing process.

Why biologics would be difficult to replicate after the patent expires

  • Biologics are harvested from living cells and are often produced using complicated manufacturing processes.
  • Most modern biologics are assembled inside vats — or bioreactors — that house genetically engineered microbes or cell cultures and can often take a whole decade of research to perfect.
  • So replicating the process isn’t exactly a cakewalk.
  • Meaning if you want to market your own version of a “biologic” once all the patents expire, you need some expertise and India’s Biocon is at the forefront of this revolution.
  • For the past few years, they’ve been building a “biosimilar pipeline” — copycats of famous biologics and they’ve been using it to fight cancer, diabetes, and arthritis.
  • And it’s not all that easy for most pharma companies to enter this market.

Why marketing a drug in the US gather headline?

  • Because the US provides an opportunity like no other.
  • Buying drugs here is expensive and pharmaceutical companies make a killing in the process.
  • It might not necessarily bode well for consumers.
  • But it does provide a lucrative market for potential Indian manufacturers who are looking to sell their products elsewhere.

Consider the question “What is biosimilar technology? How is it different from generic medicine? Discuss its application.”


Growing expertise of Indian pharmaceutical companies in the complex research area bodes well for the Indian pharma sector which is known otherwise for the manufacturing of generic medicines.


Reference Source:

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