Even notice how different doctors, at least in non-regulated countries, mention different brand names on their prescriptions for drugs that contain the same ingredients and are for the same purpose? This is because the main active pharmaceutical ingredient (API) of that medicine is a generic product and not a patented one.
So, what are generic drugs, and are they less effective or fake copies? The answer is “No”. When a pharmaceutical company gets approval for a new drug, it is given a patent to sell it with its own brand name for a specified number of years. Once the patent expires, other pharma firms get the freedom to create that same drug composition and market it under their names. These drugs are known as generics, and if the generic is for a biologic drug, then the term used is ‘biosimilar’.
Although conventional medicines have been around for a long time, people have recently become aware of their potential side-effects. Hence, biologics, which are made from living cells derived from animals or people themselves, are now becoming popular. However, since this is a new technology, these drugs are expensive, which drives the demand for their generic versions, which are comparatively cost-effective.
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Biosimilars Market Growth and Future Analysis
The most-common biologic currently is insulin, because over 10% of the global population aged between 10 and 79 has diabetes. Humulin or Huminsulin by Eli Lilly and Lantus by Sanofi are two of the well-known human insulin brands. While Humulin is short-acting type, Lantus is long-acting type. Both have different utilities depending on the severity of the disease. Some people also use a combination of short- and long-acting insulin, as recommended by their endocrinologist.
Moreover, all kinds of antiviral vaccines are classified as biologics and their generics as biosimilars. This is because they use either just the DNA or the inactive form of the pathogen to boost the body’s immune response during an actual invasion by a living virus. The world of vaccines received an unprecedented boost during the ongoing COVID-19 pandemic, when almost every biopharma and even conventional pharmaceutical company scrambled to bring their vaccines to the market.
As per an article in the New York Times, by March 2023, over 5 billion people around the world had received their COVID-19 vaccines. However, there are at least 2.7 billion more people who inhabit the earth who need to be immunised. And, learning from the pandemic and with the relentless efforts of agencies like the WHO and UNICEF, countries will likely include COVID-19 vaccination in their essential paediatric immunisation programmes.
So, as the population continues to grow and COVID-19 not likely to go anywhere (it may not have outbreaks this severe, but will probably be like common cold, of which it is a form), the demand for vaccines will continue to boom. And, while most of these biologic medications are still protected by patents, they won’t be after a while. Moreover, the average duration for which a patent is granted varies by country. For instance, while the FDA grants a drug patent for 20 years, India grants one for only 5–7 years.
Hence, with time, biosimilars of COVID-19 vaccines could be a significant opportunity for biopharmaceutical companies focussing on generic medications, boosted by international efforts to augment their accessibility in developing and under-developed countries.
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