BIOSIMILARS - Regulatory Framework and Pipeline Analysis
Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar. It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future
The scope of the report includes -
Global Biosimilars Market Value Could Hit $55 Billion by 2020, says GBI Research
The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with growth primarily driven by a promising pipeline in active development and government efforts to reduce healthcare spending, according to business intelligence provider GBI Research.
The company’s latest CBR Pharma report* states that biologics currently account for between 17–20% of the pharmaceutical arena, with a value of nearly $200 billion, and these products may replace 70% of chemical drugs in the next two decades.
Sumith Ladda, Analyst for GBI Research, says the 30% to 50% reduction in biosimilar prices compared with branded biologics could lead to considerable savings in healthcare expenditure.
Ladda comments: “There are currently 642 biosimilar trials being conducted, with 146 unique molecules. Biosimilars are most focused on oncology therapy, with a 36% share, while immunology treatment comprises 21% of the pipeline, meaning these two segments account for more than half of the total trials.
“Historically, simple proteins, such as filgastrim and epotien, were the prime targets of biosimilar development, but the focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent.”
GBI Research’s report also states that while a regulatory framework for biosimilars has been established in all major markets, some aspects, such as interchangeability, naming conventions and extrapolation across indications, need to be harmonized.
Ladda continues: “The European Medicines Agency has the most robust and longest-standing guidelines for biosimilars. Countries such as Japan, China, and South Korea have developed guidelines similar to these.
“The US Food and Drug Administration finalized guidelines for biosimilars in 2014 and approved its first biosimilar, Zarxio, on March 6, 2015. This marks the entry of biosimilars in the US, and has increased industry confidence in the country’s biosimilars market.”
The analyst adds that the US biologics space is twice the size of its European equivalent by value, but the uptake of biosimilars in Europe is nearly four times higher, indicating the significant future potential of biosimilars in the US.
*Biosimilars – Regulatory Framework and Pipeline Analysis
This report provides a regulatory overview and market outlook for biosimilars, both globally and across the major markets of Europe, the US, India, South Korea, Japan, and China. It includes market dynamics, analysis of key players and an evaluation of the pipeline.
This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.
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