DR Ambedkar IAS Academy

What are Biosimilars?

A biosimilar is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. The cheaper but equally effective bio-therapeutic medicines  are produced from biological sources such as cells rather than synthesised chemicals. Biosimilars to biologic drugs are what generics are to chemical drugs. Biosimilars are officially approved versions of original “innovator” products, and can be manufactured when the original product’s patent ends.The availability of bio-similars has decreased prices, making even innovative treatments more affordable and hopefully available to more people.Unlike generic medicines, the complex molecular structure of biosimilar drugs meanspharmaceutical companies have to invest in additional research to prove that the efficacy of their versions is similar to the original. According to a recent report by Morgan Stanley, as many as nine drugs in the biologics category have either gone off patent or will do so by 2025

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.

Utility of patents in the pharmaceutical industry

Success in this market is deeply intertwined with theresearch 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.

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