Biologics and Biosimilars – A Natural Alternative?

You’ve eaten organic vegetables. You’ve used organic soap. But have you ever heard of organic drugs

So-called ‘biologics’ are an emerging class of therapeutics, which are extracted from, or created using, a biological source.

The world’s current pharmacopeia almost exclusively consists of small-molecule drugs, which are designed to mimic or manipulate biological processes, and are synthesised chemically in a laboratory. One of the most common obstacles in classical drug development is the appearance of unwanted, off-target side effects, caused by insufficient selectivity. To think of the number of otherwise-effective drugs which may have been discarded due to off-target adverse effects truly boggles the mind.

This is where biologics have the upper hand. Rather than mimicking small components of biological molecules, they are the biological molecules.

One of the most famous biologic drugs is insulin. As porcine and bovine insulin were known to occasionally induce allergic reactions, the scientists of the time developed a strain of E. coli bacteria that synthesises human insulin [1]. This insulin has been used by diabetic patients ever since, and is widely regarded as the first biologic drug.

Today, the development of biologics focuses on vaccines, blood components, gene therapy and in particular, antibodies. Antibodies are small proteins produced by the immune system, which attach to specific antigens on target molecules, targeting them for degradation by immune cells.

One promising class of drug currently in development, are antibodies for amyloid beta proteins. These proteins accumulate in the brains of patients with Alzheimer’s disease, forming plaques which are believed to make a significant contribution to the cognitive decline associated with the disease [2]. These antibodies identify and bind to amyloid beta proteins, and target them for removal by neuro-immune cells. If approved, these will become the first ever successful treatment for the cognitive decline of Alzheimer’s disease – a truly monumental landmark for modern medicine.

Other classes of biologics currently in development include factor VIII antibodies as anti-coagulants [3], CGRP antibodies as migraine therapies [4], and nogo-A antibodies as facilitators of post-stroke neuroplasticity [5].

One barrier to the success of biologic drugs, however, is their production cost. Generating molecules from mammalian cells is a time-consuming and laborious process – they cannot be produced in the mammoth quantities that classical drugs are. This means that these drugs are often relatively expensive [6]. One way around this, however, is the development of ‘biosimilars’.

Biosimilars are developed to be an almost identical copy of a biologic template drug. Although these drugs do slightly differ from their template in structure, their mechanism of action, administration method, safety and efficacy need to be the same, in order to be approved. This means the drug has no clinically meaningful differences to the original biologic drug from which it owes its structure and function, but is able to be produced more quickly and is therefore cheaper [6].

This means that biosimilars provide a perfect balance between the innovation and specificity of biologics, and the production efficiency of classical drugs – a perfect combination for pharma companies, healthcare professionals, and patients alike. For this reason, biosimilars are expected to become one of the blockbusters of upcoming pharmaceutical development.

Another string to the biosimilars’ bow, is they are based on an already-approved drug. This means pharmaceutical companies can be more confident during the development process that the drug will be safe and effective, leading to a swifter emergence to the market.

One example of a biosimilar is Amjevita – an anti-inflammatory drug used to treat rheumatoid arthritis and Crohn’s disease, which was developed to be ‘biologically similar’ to adalimumab (proprietary name – Humira) [7]. Perhaps one of the most exciting applications of biosimilars, however, is their use in treating cancer. One anti-cancer biologic, trastuzumab (proprietary name – Herceptin), has generated five – count them, five biosimilars since 2017 [8]!

This month even saw the announcement of the world’s first Halal biosimilar, being produced in Malaysia [9].

As you can see, it is clear that biologics and biosimilars will play a key role in the future of pharmacology. Experts predict that these drugs will soon account for around 30% of all new drugs coming to market [10], making them a multi-million-dollar enterprise – so it’s no secret that their recent emergence is massive business.

Treating diseases using the very molecules that nature provides us with, to treat diseases – this really is science at its very best.

Almost puts your organic soap to shame, doesn’t it?

Chas Alexander Smith


  2. Clinical Trials Arena. 2020.Biogen Drug Aducanumab Receives FDA Approval For Alzheimer’s. [online] Available at: <> [Accessed 21 July 2020].
  3. com. 2020.Biotest AG: Biotest Presented Promising Data On Next Generation Recombinant Factor VIII At ISTH 2020. [online] Available at: <> [Accessed 21 July 2020].
  4. Mellilo, G., 2020.Review Finds Erenumab Safe, Effective In Treating Chronic, Episodic Migraine. [online] AJMC. Available at: <> [Accessed 21 July 2020].
  5. Smith, J., 2020.Swiss Biotech Raises €8.8M To Progress Regenerative Stroke Treatment. [online] Available at: <> [Accessed 21 July 2020].
  6. Anderson, M., McGlynn, K., Rice, T. and Shmuel, J., 2020.Introduction To Biologics And Biosimilars | JD Supra. [online] JD Supra. Available at: <> [Accessed 21 July 2020].
  7. S. Food and Drug Administration. 2020.FDA Approves Amjevita, A Biosimilar To Humira. [online] Available at: <> [Accessed 21 July 2020].
  8. Staines, R., 2020.Amgen’s Cancer Biosimilars Stay On US Market As Court Battle With Roche Ends –. [online] Available at: <> [Accessed 21 July 2020].
  9. Hagen, T., 2020.World’s First Halal Biosimilar To Be Produced In Malaysia. [online] Center for Biosimilars. Available at: <> [Accessed 21 July 2020].
  10. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar 2016.

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