On July 24th the FDA accepted its first application
for a biosimilar drug in the U.S. and put the industry on alert that this new
market is fast approaching. While no one knows exactly when the first approval
will come, here are a few facts to bring you up to speed for when it does:
· • Estimates on savings
attributed to biosimilars range from $42 - $108 billion over the first ten
years of the market.
• Per the Rheumatology
Network, over the span of their lifetime, many drugs approved in the US
and EU have eventually become “biosimilars” of themselves. This is due to a “natural drift” in drug
properties caused by changes in production such as using different batches of
medium or manufacture at different sites.
• Recently, a group of 19 investors representing
nearly $430 billion in assets commended
Novartis and Amgen for supporting a set of investor principles to guide boards
on activities related to biosimilars.
• A survey
conducted among senior’s organization RetireSafe shows that 92% were
unaware that the Affordable Care Act potentially allows for biosimilar drugs to
be substituted for a biologic. Furthermore,
this could potentially be done without the patient or doctor being aware.
• Hospira is looking to file its first biosimilar
in the US within twelve months and currently has an R&D
pipeline valued at around $40 billion.
• Amgen is developing a portfolio of biosimilars
of which three are slated to launch in 2017.
We’ll have more on the latest developments in the
biosimilars market at the 15th Annual Business of Biosimilars meeting.
Join us October 20-22 in Boston, MA. Download the agenda to see what’s on
tap.
SAVE $100. Register here and use code XP1986BLOG.
|
Share this article with your social network, just click below to share now!
|
|
|
No comments :
Post a Comment