Biosimilars are biological products that are approved by the FDA to be highly similar to an already-approved biological product, known as a reference product. Biosimilars are also called subsequent entry biologics (SEBs). Biosimilars can be used to treat the same conditions as the reference product.
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The FDA has a pathway for approving biosimilars that meets the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The pathway includes showing that a biosimilar has the same high level of safety and effectiveness as the reference product. The FDA has approved several biosimilars, and more are in development.
Key Trends
The biosimilars market is expected to grow significantly in the next few years. The key drivers of this growth include the expiry of patents for biologic drugs, the increasing number of biosimilar products in development, and the growing awareness of biosimilars among patients and healthcare providers.
The number of biosimilar products in development has increased significantly in recent years. In Europe, there are currently more than 100 biosimilar products in clinical development, and this number is expected to grow in the coming years. In the United States, the FDA has approved several biosimilar products, and more are in development.
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The increasing awareness of biosimilars among patients and healthcare providers is also driving growth in the market. Biosimilars are often seen as a more affordable alternative to biologic drugs, and they are also associated with a lower risk of adverse events.
The key trends in biosimilars technology are the increasing number of products in development, the growing awareness of biosimilars, and the increasing use of biosimilars in clinical practice.
Key Drivers
The key drivers of the biosimilars market are the expiry of patents for biologic drugs, the increasing prevalence of chronic diseases, and the growing demand for biologic drugs.
The expiry of patents for biologic drugs is the primary driver of the biosimilars market. Biologic drugs are large, complex molecules that are difficult to replicate. As a result, when patents for these drugs expire, there are few companies that are able to produce biosimilars. The increasing prevalence of chronic diseases is also a driver of the biosimilars market. Chronic diseases, such as cancer and diabetes, require long-term treatment with biologic drugs. The growing demand for biologic drugs is also a driver of the biosimilars market. Biologic drugs are used to treat a variety of conditions, including cancer, autoimmune diseases, and inflammatory diseases.
Restraints & Challenges
The biosimilars market is still in its early stages of development, and there are a number of challenges that need to be addressed before it can reach its full potential. One of the key challenges is the lack of regulatory clarity around the world. In Europe, for example, biosimilars are regulated as generic medicines, while in the United States they are regulated as biological medicines. This difference in regulatory approach has created a complex and uncertain environment for biosimilar developers, which has made it difficult to bring products to market.
Another challenge facing the biosimilars market is the high cost of development. Biosimilar medicines are much more complex to develop than traditional small molecule drugs, and this complexity is reflected in the cost. It is estimated that it costs around $250 million to develop a biosimilar medicine, which is around 10 times more than the cost of developing a small molecule generic drug.
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Key Market Segments
The biosimilars market bifurcated on the basis of product, application and region. On the basis of product it is segmented into insulin, granulocyte colony-stimulating factor, erythropoietin, and others. By application, it is spread across oncology, blood disorders, growth hormonal deficiency, and others. Region-wise, it is studied across North America, Europe, Asia-Pacific, and rest of the World.
Key Market Players
The biosimilars market report includes players such as Amgen (USA), Mylan (USA), Novartis (Switzerland), Sandoz (A subsidiary of Novartis) (Switzerland), Pfizer (USA), Biocon (India), Celltrion (South Korea), Samsung Bioepis (South Korea), Teva Pharmaceuticals (Israel), and Hospira (A subsidiary of Pfizer) (USA)
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