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Overview of the Biosimilars Market, Including a Regulatory Update

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Biosimilars Series: Forecast Analysis
Biosimilars Series: Forecast Analysis
Datamonitor

The high cost and utilization of biologic drugs, coupled to the growing need to curb pharmaceutical expenditure, provides considerable momentum to the emerging biosimilars market. With a biosimilar approval pathway in place in Europe and Japan, and imminently in the US, we expect payer pressure to drive biosimilar uptake, particularly in Germany, the US, and the UK.

Scope

- Molecule specific forecasts for biosimilar epoetin alpha, filgrastim, interferon beta, interferon alpha, human growth hormone, and insulin-glargine

- Molecule specific forecasts for France, Germany, Italy, Spain, the US, and Japan through 2019

- An overview of the emerging biosimilars market, including a regulatory update

- An outline of the key issues which will impact on biosimilars uptake going forward.

Highlights

As the first to introduce guidelines for biosimilar drug approval, Europe has emerged as the testing ground for biosimilar drugs, with biosimilars for three biologics having entered the market to date human growth hormone, epoetin alpha, and filgrastim.

The size of the US market, combined with the voracious generic erosion that characterize it, make it an attractive prospect for would-be biosimilars makers, and as such, it represents the real prize, contingent on the creation of a biosimilars approval pathway.

Although guidance for biosimilar approval was issued in Japan in 2009, this market is unlikely to experience significant biosimilar incursion through the forecast period, contributing at most 1% to total seven major market volume sales in 2019.

Reasons to Purchase

- Learn how biosimilar uptake for six biologic drugs is anticipated to change through 2019, in France, Germany, Italy, Spain, the UK, the US, and Japan

- Understand how the seven major markets compare in terms of speed and extent of biosimilars uptake

- Identify the key molecule and market specific drivers and resistors to biosimilar uptake


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151 pages

Publication Date : June 2009
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