Only FDA Approval Pathway Complications are Holding Back the US Biosimilars Flood

Published: Jul 17, 2012

NEW YORK (GBI Research), 17 July 2012 - New guidelines laid out by the US Food and Drug Administration (FDA) lack clarity and specificity, meaning that a wealth of biosimilars are currently restricted from the world’s biggest pharmaceutical market, states a new report from healthcare industry analysts GBI Research.

The report* says that ambiguity within the healthcare authority’s approval pathway procedure suggests decisions will be made on a case-by-case basis, hindering the flow of biosimilars into the US market.

As biosimilars require high investments and long periods of development compared to generics, companies need to know in advance what US regulators will require when they submit their applications for the approval of a new product. GBI Research expects the first biosimilar to be approved in the US by the end of this year, followed by products by Sandoz and Hospira in early 2013. Once these medications have broken through, and a clearer approval pathway is established, an abundance of biosimilars is expected to follow and take advantage of the highly lucrative US pharmaceutical market.

Europe has already approved 14 biosimilars – the highest of any region – with a range of products belonging to the erythropoietin (EPO) and granulocyte colony stimulating factors (G-CSF) and human growth hormones (HGH) groups. Japan launched its first biosimilar in October 2009.

The reduction of healthcare expenditure is at the top of the agenda for national healthcare authorities around the globe, and as biologics are among the highest priced therapies in the world, establishing governing regulations is a key focus. GBI Research predicts that the value of the worldwide biologics market will rocket from $450m in 2011 to $7.5 billion in 2018, climbing at a highly impressive Compound Annual Growth Rate (CAGR) of 49.6%. This staggering jump is attributed to the entrance of the US into the global biologics market.

* Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

This report provides key data, information and analysis of the major trends and issues affecting the biosimilar market in developed countries covering the US, the top five European markets and Japan.

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.


GBI Research is a market-leading provider of business intelligence reports, offering actionable data and forecasts based on the insights of key industry leaders to ensure you stay up-to-date with the latest emerging trends in your markets.

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