Drugs & Updates

Biosimilars: A coming-of-age story

Since the birth of biotechnology, a lot has been learned and deciphered about the central dogma of life. Specialised biological function of genes, proteins, immunology and disease pathogenesis in the body have been untangled, ushering us into the era of biotherapeutics. The biotherapeutics sector is booming, but what exactly are biotherapeutics, and how do they affect our life?

Unlike small molecules like aspirin which can be chemically synthesised, biotherapeutics are molecules synthesised using the power of living cells. They are large and more complex that they cannot be produced on a lab bench. It is often a comparison between a cycle and a fighter jet in terms of size and complexity. Of course, we can further divide them into novels, biosimilars and bio-better. Biosimilars mean a molecule highly similar to an innovator product whose patent is expiring soon. There is no clinically meaningful difference between the innovator and the reference drug; hence, the biosimilar does not need to go through all the phases of clinical trials. This, however, does not mean they are unsafe or ineffective.

The use of biotherapeutics is evolving and has become an integral part of modern medicine. They are increasingly used to treat and prevent serious diseases, illnesses, and infections like cancers, diabetes, autoimmune diseases, and more. Biotherapeutic products include a wide range of products including proteins, monoclonal antibodies, cytokines , gene cell therapy products, vaccines, and more to target or detect disease accurately. Monoclonal antibodies or mAbs are a unique and complicated biotherapeutic produced in B cells that function via apoptosis in cells that block target molecular functions. mAbs are an essential part of the biotherapeutics portfolio because they are the recent top 10 blockbuster drugs used for the treatment of cancer example, trastuzumab.

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How are they made?

It begins by using a piece of DNA that codes for a biotherapeutic of interest. We can produce these in the lab by using an appropriate host cell capable of accurately producing the protein and some scientific sorcery. For commercial production, we prefer a high-producing cell strain; this leads to screening and selecting a high producer. Further process optimisation involves choosing the best conditions to produce the maximum product. This entire process is called upstream bioprocessing. This is followed by downstream processing, which is nothing but a series of steps to purify the product. Once you have this magic portion, a series of wizardry and regulatory approvals are also required for a company to be able to market the product.

Economics of biotherapeutics

With the high cost of pharmaceuticals, especially biologics and ever-increasing healthcare costs, manufacturing biosimilars makes them affordable and increases competition in the market. The average daily cost of a biologic in the United States is $45 compared to only $2 for chemical drugs. There are considerable commercial opportunities with biosimilars as sales of biologics amounted to more than $200 billion in 2020 and are only expected to increase in the coming years. Since innovators have to compete with the innovator company, there is increased investment in newer technology, platforms, and processes to reduce the cost of manufacturing. But innovator companies respond to the potential entry of biosimilars by various strategies to maintain a market monopoly. The most common strategy is improving the first-generation products either by making the product more effective or efficient dosing or administration technologies that may extend patent protection. Other strategies include price decreases, patent defences, extensions, as well as the use of trade secrets. A great example is including the enzyme hyaluronidase with biosimilars to reduce treatment time from 2.5 hours to 5 minutes.

Challenges

There is still phenomenal growth ahead for the biotherapeutic industries. Developments in immunotherapies like Cart T therapy, antibody-drug conjugates, Personalised medicine, regenerative cell therapy and gene cell therapies are all future of biotherapeutics.

Author

Jyoti Rawat

Dr. Jyoti Rawat is a biology researcher by profession. Her research focuses on making life-saving drugs more affordable. She is interested in seeing more women in science. She cooks, paints, and tends to plants in her free time.

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