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.
• The value of biologics slated to come off patent by 2017 is about $70 billion.
• 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.
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