The Use Of Biosimilars : The New Frontier Of Decreasing The Cost Of Development And Treatment For Patients Essay
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The use of biosimilars is one of the newest advancement in healthcare in treating those with rare diseases. Biosimilars are also known as a follow-on biologic which is a biologic that is a copy of the original product that is manufactured by a different company. A biologic is manufactured in a living system such as a microorganism, plant, or animal cells. Most biologics are very large, complex molecules or mixtures of molecules that are produced using recombinant DNA technology. The use of biosimilars, like other generic drugs, is part of the new frontier of decreasing the cost of development and treatment for patients. Though this new advancement would be undoubtedly beneficial to the masses, this new development is not without its challenges.
In the United States many biologics today are produced in other countries and imported for consumer use. Since there is a relationship between European and US regulating agencies in relation to biologic, it would make sense to introduce a new drug development that would in turn be beneficial to patients while lowering the cost of their treatment. Many of these biosimilars are produced in European companies, therefore, a relationship between the US and European regulations of biosimilar products need to coalesce primarily for the sale and utilization of products in both regions. US regulation agencies and European agencies do not have equal views on the regulation of biological products such as GCP and inspections. The