India approved its first biosimilar much before the United States and Europe. India has a thriving biosimilar ecosystem in comparison to other countries and because of that Indian pharmaceutical companies have risen as the global market leaders in biosimilars. Now there are multiple biosimilars developed by biopharmaceutical companies and used across the world for wide range of areas such as diabetes, ophthalmology, and respiratory to cancer and connective tissue diseases. The latest one to be approved was pegfilgrastim-jmdb in June 2018 to reduce the risk of infection following myelosuppressive chemotherapy.

But since then, FDA has approved a number of biosimilars for the treatment of cancer and other conditions. United States followed this much later when in 2015 it approved filgrastim-sndz, a biosimilar to filgrastim (granulocyte CSF), whereas filgrastim was approved by the USFDA in 1991. The first biosimilar, Omnitrope (a recombinant human growth was), was approved in Europe by the European Medicines Agency (EMA) in 2006. The biosimilars have huge potential to reduce the overall cost of treatment, which was evident from a study carried out in United States where it was estimated over 10 years biosimilar can save 54 billion US dollar in the United States.Įurope was the first in the world to formulate the policy framework for the approval of the biological product. Health-care experts and physicians are optimistic that use of biosimilars may reduce the cost of biologics and eventually lead to better patients’ access to these lifesaving drugs. Many believe that biosimilars will have a positive impact on the drug pricing. But similar biologics are not exactly identical to reference biologics because of the complex structure, which may be affected by minor alteration in sequences and posttranslational modifications. Biosimilar is a biologic product, which is very similar to Food and Drug Administration (FDA)-approved biological product known as reference product and has no clinically meaningful differences in term of safety and effectiveness from the reference product. But the silver lining is that once the innovator company loses their intellectual property right and patent protection after a stipulated period, it opens the window of opportunities for companies evince an interest in manufacturing similar products, which cost less, and at that time, it is known as biosimilar or similar biologic. Biologics are one of the top selling drugs worldwide as well as in the United States but the major drawback of this drug has been its exorbitant cost, which makes it unaffordable and inaccessible to many patients, especially in developing countries where a large number of people are poor and the concept of health insurance is at its nascent stage.

Biologics have benefitted the patients with rheumatologic diseases, inflammatory bowel disease, malignant conditions, dermatological conditions, and other connective tissue disorders by halting the disease progression, alleviating the symptoms, and improving the quality of life. Biologics are derived from the natural resources such as human, animal, or microorganism and manufactured by various biotechnology methods such as recombinant deoxyribonucleic acid technology, controlled gene expression, and antibody technology.

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