Biosimilars are the officially approved versions of biopharmaceutical products that are manufactured by a different company following the patent expiry of the original product. Also known as subsequent entry biologics or follow-on biologics, biosimilar drugs are gaining popularity around the world as the development cost of biosimilars is not as high as the original drug.
Also, the regulatory frameworks put in place by many countries are aiding the growth of biosimilars in the world, not to mention the lengthy tendering process of biologics that delays the actual launch of the drug. Meanwhile, biosimilar tendering is becoming more and more commonplace as the uptake of biosimilars is growing.
Aruvian Research analyzes the global biosimilars industry in its research report Analyzing the Global Biosimilars Industry 2016.
In this research report, we analyze what biosimilars are through an industry definition in the EU, US and Japan. We look at the development of biosimilars, the role of the Biologics Price Competition and Innovation Act, and the role of data exclusivity in the Patient Protection & Affordable Care Act for Biosimilars.
The specific nature of biosimilars and the types of biologics available and role of biosimilars are also analyzed, along with the importance of biosimilars and a comparison between biosimilars and generic drugs.
An overview of the biopharmaceutical industry in included in order to understand the growing importance of biosimilars.
Moving to the analysis of the global biosimilars industry, we analyze the market value, market size, upcoming patent expiries for branded biologics and the operating margins of biosimilar manufacturers. Market concerns regarding biosimilars is also included.
Factors driving the market for biosimilars, challenges and impacts on the industry, and industry growth factors, are all analyzed in this in-depth report.
We also take a look at the biosimilar market in developed markets and BRIC countries. Approval pathways and regulatory frameworks in the US, Europe, and Japan are analyzed, along with a comparison of European versus US legislation.
For companies wanting to enter the global biosimilars market, we carry out a market entry analysis through our section K of the report, Entering the Global Biosimilar Industry.
Analysis of competition in the industry is carried out through an analysis of the major industry players, industry suppliers, generic drug manufacturers, investors and stakeholders, major launches, and a country-wise analysis of the biosimilar industry. Biosimilar markets are analyzed in Australia, BRIC nations, EU, Japan, and the United States.
An analysis of Epoetin, Filgrastim, and Somatropin - the major biosimilars - is carried out, along with a look at the emerging opportunities for biosimilars due to the upcoming patent expiries.
The response of Big Pharma against the rise of biosimilars is detailed, followed by an analysis of the major markets and major industry players.
An industry forecast for the global biosimilars industry concludes our comprehensive and cutting-edge analysis of the Global Biosimilars Industry.
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