Abstract
Introduction
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, Datamonitor expects payer pressure
to drive biosimilar uptake, particularly in Germany, the US, and the UK.
Scope of this research
- 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.
Research and analysis 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.
Key reasons to purchase this research
- 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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