Biosimilars Market Rapidly Increasing Growth Latest Report With Future Estimations, Current Trends And Opportunity Analysis 2018-2026
Biosimilars Market |
A biosimilar is a biologic medicinal product that is essentially a carbon replica of an original product made by a separate manufacturer. Biosimilars are FDA-approved copies of original "innovator" products that can be manufactured after the patent on the original product expires.
Biosimilars Market expansion is predicted to be driven by an increase in the number of authorised biosimilars due to more clarity in the US Food and Drug Administration (FDA) review process other than the manufacturing and development process. For example, the United States Food and Drug Administration (FDA) published a Biosimilars Action Plan in July 2018 to support the development of biosimilars. This approval process encourages applicants to settle patent challenges before biosimilars are released.
The biosimilars market's primary approach is approval and clinical studies. Companies like Sandoz, Merck Serono, and Celltrion are always pursuing authorization in different parts of the world. These firms are subsidiaries of larger corporations like Merck and Novartis, allowing them to participate in biosimilar research. Clinical trials and product development investments are just as vital as approvals. Clinical studies for commercialization and clearances are undertaken in an integrated manner by the companies' strategy.
Market Segmentation:
By Types
- Human growth hormone
- Erythropoietin
- Monoclonal antibodies
- Insulin
- Interferon
- Granulocyte-Colony Stimulating Factor
- Others
By Applications
- Blood disorders
- Oncology diseases
- Chronic and autoimmune diseases
- Growth hormone deficiencies
- Others
Manufacturers are becoming more acquainted with the complex regulatory and litigation procedures associated with filing a biosimilar application, which has resulted in an increase in the number of biosimilar applications filed. For example, the US FDA has authorised 16 biosimilars since 2015, with the number projected to rise throughout the forecast period. A number of other government bodies are following similar product approval tendencies. Samsung Bioepis, for example, got approval from the Korean Ministry of Food and Drug Safety in November 2017 for its adalimumab biosimilar Hadlima (SB5) and its trastuzumab biosimilar Samfenet (SB3) (South Korea).
The key players operating in the global biosimilars market include, Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Celltrion Healthcare Co., Ltd., Biocon Limited, Amgen, Inc., Dr. Reddy's Laboratories, and Sanofi S.A.
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