The New Era of Complex Copycat Drugs - Biosimilars

Meet Rahul. He has a thing for first copies of branded products. From the pristine copies of handbags for his girlfriend… To shoes and watches for himself that are near-impossible to tell apart from the real thing. Why doesn’t he buy the original brands? He says, “I can’t afford the real thing duh”

Well, copies are everywhere. While people like Rahul buy copies of luxurious products, there’s one emerging segment of copycats that’s not a luxury but a necessity and is addressing some of the world’s biggest health problems – Biosimilars. Before we explain this — let’s take a little detour.

Biotechnology – Breads to Biologics

Biotechnology is as old as human history. It involves using living organisms to make something useful. Using yeast to make breads is an example of biotechnology. It expanded to medical uses only in 1940s with the introduction of penicillin. But modern biotechnology began in 1970s. Today, biologic drugs are a major force in the pharma industry benefiting many worldwide. But what are they?

Complex Drugs for Complex Diseases

Since the advent of medicines, small molecules have been used to treat most illnesses. Over time, the world started witnessing some complex diseases like cancer. To fight these, complex biologics were created which revolutionized the medical industry. Biologics can treat many autoimmune diseases.

Most traditional medicines are made from chemicals and are in pill, tablets or capsule form. Your Aspirin is a good example. Biologic drugs on the other hand are made from living cells and are given in an injectable format. This makes them very complex. Insulin is an example of a biologic drug.

What luxurious brands are to Rahul, Biologics are to the patients. They are expensive. So, we enter the world of Biosimilars.

Biologics’ First Copies - Biosimilars

Biologics take more time and resources to make than traditional medicines. They also take longer to bring to market (10-15 years vs 7-10 years for small molecule drugs). Most importantly, they are utterly expensive! That is why Biosimilars have entered the picture.

Biosimilars are very close to, but not exactly the same as biological drugs. But they work the same way, given the same way, and are safe as original biologic drugs. Biosimilars are less costly to make than biologics. This means these useful medicines may be available to more people.

Not As Simple As – Cut, Copy, Paste

Mind you, replicating the biologics isn’t as easy as creating the first copies of Rolex or Gucci bag. Biologics are made by reproducing, or growing, copies of a specially engineered living cell. This process begins by growing the cells in a carefully controlled facility. Note that these biologic companies do not share their complex formulas. They are patent-protected. Hence, biosimilar guys have to follow a cumbersome process to reverse-engineer, prove the bioequivalence and then bring the first copy out.

Ok, now don’t let the medical mumbo-jumbo scare you. What these biosimilar companies do is – either challenge the biologic company’s patent or wait for the patents to expire to market their own version of the original drug.

India in the Forefront

Indian companies like Biocon (the first Indian company to receive a USFDA approval for a biosimilar) exactly has this expertise. They have a great biosimilar pipeline and are building biologic copycats of diabetes, cancer and arthritis drugs.

Notably, a lot of the biologic patents are set to expire soon. This gives its biosimilar competitors an opportunity to create cheaper versions. With India's strength in the global generics market, Indian pharma and biotech companies are now gearing up to establish themselves as key Biosimilar players. Within the next few years, the biosimilars market is expected to evolve rapidly and transform.

Proof of the current momentum can perhaps be seen in the fact that India has around 127 approved biosimilars pushed by companies like Zydus Cadila, Biocon, Dr.Reddys, Sun Pharma, Lupin, etc. This makes India with the largest number of approved biosimilars after Germany and the US (as per Informa’s Pharma Intelligence 2021). That’s promising, isn’t it? Let’s see where the Indian Biosimilar companies stand 10 years down the line.

References: Bio Spectrum

ACRI

Finception

Nature