Biosimilar products are suspected to continue to have a significant impact on the pharmaceutical industry. Many regulatory bodies have established clinical guidelines to support the development of biosimilars, laying down the requirements for demonstrating comparable pharmacokinetics, pharmacodynamics, safety and efficacy from Phase I on to controlled, randomized Phase III trials.

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Although biosimilars are not required to undergo intense clinical trials for their approval, the data demonstrating their similarity to an original biologic in terms of clinical efficacy and safety is required. The adoption of biosimilars varies from country to country, which is invariably linked to regulatory and market access issues. The biosimilars market is expected to witness significant growth, owing to expiry and termination of existing drugs and presence of rich pipeline of biosimilar products especially those in Phase III stage.

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).

Increasing number of biosimilar approvals is expected to drive the growth of biosimilars market

Increase in number of approved biosimilars due to greater clarity in the U.S. Food and Drug Administration (FDA) review process other than manufacturing and development process are expected to drive biosimilars market growth. For instance, in July 2018, the U.S. FDA introduced a Biosimilars Action Plan to encourage the development of biosimilars. This approval process encourages applicants to resolve patent disputes before launch of biosimilars.

Moreover, the number of filed biosimilars applications has increased as manufacturers have become more comfortable with the complex regulatory and litigation schemes associated with filing a biosimilar application. For instance, since 2015, the U.S. FDA has approved 16 biosimilars and the number is expected to increase over the forecast period. Several other government agencies are also following similar trends for product approvals. For instance, in November 2017, Samsung Bioepis received two approval for its adalimumab biosimilar, Hadlima (SB5) and for its trastuzumab biosimilar, Samfenet (SB3), from the Korean Ministry of Food and Drug Safety (South Korea).

Market Dynamics

Increasing number of biosimilar approvals in clinical management of various diseases such as diabetes and hormonal imbalance is expected to drive growth of the biosimilars market. According to the Generics and Biosimilars Initiative (GABI) 2017 report, around 40 different biosimilars were approved in Europe, covering several different therapeutic classes: granulocyte colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs), among others.

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Moreover, increasing research and development in biosimilars, robust biosimilar pipeline portfolio, and support from healthcare regulatory bodies in fast lining biosimilar approvals are some of the major factors that are expected to drive growth of the market. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both provide guidance for the development of biosimilar drugs. However, stringent regulatory guidelines for development and manufacturing of biosimilars and fragile process of biosimilars production are expected to negatively impact growth of the global biosimilars market.

Biosimilars Market - Competitive Landscape

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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