Global Biosimilar Market Forecasts Trends, Share, Size, Growth, Opportunity

Biosimilar Market

A biosimilar is a biological medical product that is nearly identical to an original product manufactured by a different company. Biosimilars are officially approved copies of original "innovator" products that can be manufactured after the patent on the original product expires. The product of the innovator is mentioned in the approval. Unlike the more common small-molecule generic drugs, biologics have a high level of molecular complexity and may be extremely sensitive to changes in manufacturing processes

The global Biosimilars Market size was valued at US$ 5.0 billion in 2017, and is expected to witness a CAGR of 35.2% over the forecast period (2018 – 2026).

 All biopharmaceuticals, including bio similar The rising global burden of chronic diseases such as cardiovascular disease, diabetes, cancer, and kidney failure is fuelling the growth of the Biosimilars market. Biosimilars treat a variety of chronic diseases at low cost, and as a result, they are gaining popularity among global consumers. Another major driver that may increase demand for biosimilar drugs is the rising prevalence of diabetes. Diabetes, according to the World Health Organization, is the leading cause of blindness, kidney failure, stroke, and heart attacks. The availability of low-cost biosimilar drugs for the treatment of such serious diseases is driving market expansion.rs, must maintain consistent quality and clinical performance throughout their lifecycle, regardless of their differences.

Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and Health Canada's Health Products and Food Branch have guidelines on the requirements for demonstrating the safety and efficacy similarity of two biological products. They claim that despite minor differences in clinically inactive components, animal studies, and clinical study or studies, analytical studies show that the biological product is highly similar to the reference product. They are adequate to demonstrate the reference product's safety, purity, and potency in one or more relevant conditions of use for which the reference product is licenced and intended to be used, as well as for which biological product licensure is sought.

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