In recent times, there has been a steep rise in the demand for cheap drugs because of the growing prevalence of various diseases across the world. One type of cost-effective drugs which is rapidly gaining traction in the healthcare domain is a biosimilar. In simpler terms, a biosimilar is defined as a biologic or a biologic medical product which is extremely similar to a commonly used generic drug, which is itself based on the reference medicine.
Both generic drugs and biosimilars are widely marketed and advertised as cheaper alternatives to expensive branded medicines. They are available when pharmaceutical firms’ exclusive patents for costly new medicines expire. This high level of similarity that exists between the two products often leads to confusion and unpleasant situations for buyers at medical stores and pharmaceutical outlets. Therefore, it is important to understand the key differences between the two. After all, those awkward stares, sideways glances, and eye-rolls are not the things we usually look forward to while visiting a drug store, right?
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Generics vs Biosimilars
While generic drugs are extremely identical to the original medicines in terms of chemical composition, biosimilars are only similar to the original drugs in terms of their clinical and therapeutic results. Moreover, generic drugs are exact copies of the original synthetic drugs, while biosimilar drugs normally use living beings as essential ingredients. As per the Regulatory Consideration for Biosimilar Products report published by Soo-Kyoung Suh, Ph.D., a biosimilar is “A biotechnological product that is proved to be comparable to an already-approved reference product in quality, non-clinical, and clinical evaluation.”
Because of the inexpensive nature of these drugs as compared to the original medicines, surging investments being made in R&D activities by numerous biopharmaceutical firms, and rising incidence of chronic diseases, the sales of biosimilars are soaring all over the world, as a result of which the global biosimilars market is exhibiting rapid expansion.
Why Are Biosimilars Becoming Important?
- Increasing Geriatric Population: Since the last few years, there has been a sharp rise in the population of elderly people all over the world. This is mainly because of the rapid advancements being made in the healthcare domain, growing healthcare expenditure in many countries, rising public awareness on various medical conditions, and ease of access to proper medical care. As per the United Nations, “There were 703 million persons aged 65 years or over in the world in 2019. The number of older persons is projected to double to 1.5 billion in 2050.” The surge in the geriatric population will push up the prevalence of diseases and ailments, which will, in turn, boost the requirement for biosimilars.
- Growing Incidence of Chronic Diseases: As mentioned above, this is another important factor which is positively impacting the sales of biosimilar drugs across the world. Due to the rising stress levels in people, increasing consumption of fast foods and other unhealthy food items, and surging adoption of a sedentary lifestyle, the incidence of chronic diseases and ailments is rapidly shooting up in all age groups. According to the findings of the World Health Organization (WHO), 31% of all deaths across the globe were caused due to cardiovascular diseases in 2016. Further, cancer was the second-biggest cause of deaths, claiming the lives of nearly 9.6 million people in 2016.
- Lower Cost of Biosimilars: One of the things that make biosimilars so popular, especially among the middle-class people, is their lower costs in comparison to branded drugs. As per the Pharmaceuticals Journal, the costs of biosimilar drugs are 10–70% lesser than branded biologics. For example, compared to the $6.7 million for rituximab biologics, the total cost of a six-month-long treatment based on biosimilar drugs is only $3.3 million.
- Soaring R&D Investments: The rising investments being made by several organizations in R&D for biosimilars are also contributing to their popularity. Because of the ballooning R&D projects, several biosimilar products are either in the pipeline or already being marketed by various biopharmaceutical companies across the world. For example, as of 2019, Teva Pharmaceuticals Industries Limited has two biosimilar drugs, called Truxima — a rituximab injection — and T-P62 — trastuzumab biosimilar — in its pipeline.
What Are Most Widely Used Biosimilar Products?
Recombinant non-glycosylated proteins, recombinant peptides, and recombinant glycosylated proteins are the most widely sold biosimilar products. Out of them, the utilization of recombinant glycosylated proteins was found to be the highest in the past. The lesser complexities associated with these drugs, because of the glycosylation process, which increases the stability of the protein, makes them popular. Moreover, these drugs easily get approvals from the regulatory bodies for distribution and mass consumption. These proteins further comprise erythropoietin (EPO), follitropin, and monoclonal antibodies (mAbs). Amongst these, the sales of mAbs are predicted to be considerably high in the coming years, because of the rising demand for such biosimilars in the treatment of chronic diseases and ailments, especially diabetes and cancer.
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Medical Applications Requiring Biosimilar Products
Speaking of the application areas of these products, rheumatology, oncology, blood-related disorders, chronic diseases, autoimmune diseases, growth hormone deficiency (GHD), and infectious diseases are the major ones. Amongst these, the usage of these drugs has been the highest in oncology till now, because of the rapidly rising prevalence of cancer. As per the findings of the WHO, almost one in every six people across the world died because of cancer in 2018.
Oncology is an evolving field, with numerous research studies being conducted to learn about the creation and proliferation of cancer and effective ways to kill or stop the tumors from growing further. Though several biosimilars have already emerged for cancer treatment, several new are being discovered and experimented, to reduce the socioeconomic impact of this now-common and highly morbid disease.
Europe the Biggest Hub for Biosimilar-Driven Medical Treatments
Historically, Europe has been the hub for biosimilar-based medical treatments. The presence of flexible regulations regarding the usage of biosimilar drugs in various European countries and a large geriatric population help increase the demand for such biologics. In addition to this, several biopharmaceutical companies in the region made huge investments in biosimilar R&D in the past, which has led to the development of highly effective and affordable drugs.
Hence, it can be inferred that the popularity of biosimilar products will surge tremendously all over the world in the forthcoming years, primarily because of the affordable prices of these drugs in comparison to branded ones and extremely high efficacy of biosimilar-based treatments.