Biosimilars are considered a milestone for the pharmaceutical industry. As the name suggests, a biosimilar is basically a biological medical product that is similar, but not exactly identical to a biologic, the original product/medicine manufactured by a different company. A biologic, also known as the ‘reference product’, is a medicine that is derived from a living cell by genetically modifying the cell through complex manufacturing processes.
Biologics are basically proteins or antibodies with very big or complex molecules. They interact with our body in order to produce the desired therapeutic results. Due to their complex structures, biologics are very sensitive to their environment, and handling and manufacturing conditions. They are used for the treatment of several diseases and disorders including cancer, autoimmune disorders, chronic kidney diseases, etc.
Biologics are quite expensive drugs and are often protected by patents. Biosimilars, also known as biogenerics, are the less expensive, similar versions of the biologics and they do not have any clinically meaningful differences regarding their safety and effectiveness from biologics. These drugs are the officially approved versions of biologics.
Biosimilars or biogenerics are different from generic medicines or generic versions of the small molecule drugs that are synthesized chemically. Generic drugs are the identical versions of the small molecule drugs, as it is possible to copy small molecule drugs exactly. But, due to their complex structures and also because they are made from living cells, it is not possible to create identical versions of biologics. This is the reason why biosimilars are merely ‘similar’ and not identical to biologics.
The advent of biosimilars has affected the pharmaceutical industry immensely. It is estimated that by 2020, they will account for about 10% of the total biologics market. Biosimilars can reduce the cost of treatment for patients as biologics are highly expensive. The production of several biosimilars for a specific biologic can reduce the price of the drug by increasing competition in the market. This, in turn, will help increase the accessibility of healthcare.
Biogenerics can also increase the treatment options for patients. An increase in treatment options, coupled with a cost reduction and increased accessibility to healthcare will ultimately have a positive impact on the lives of patients suffering from chronic and life-threatening diseases.
The biosimilar industry is expected to grow in the coming days as patents of many biologics are going to expire. However, the industry is also going to face some tough challenges related to clinical trials and the creation of awareness among physicians, patients, and pharmacists about the benefits of biosimilars. To realise its full potentials, the industry has to overcome these challenges and deliver solutions that will be more beneficial for patients and healthcare providers.