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Biosimilars: now a reality, even for complex biologics

 

The essential

Biosimilars have been a hot topic among healthcare investors for a few years now and should further take center stage over the next five years as eight out the Top 10 bestselling therapies worldwide will face biosimilar competition. Starting late but having all the relevant expertise and production know-how Biotech companies have partnered with large Pharmaceutical groups to develop biosimilars. While the BPCI Act within Obamacare set a regulatory framework for biosimilars to be approved by the US FDA, its different provisions had first to be battled in court for the law to take shape. This is now almost done.

In the US the highest barrier for biosimilar developers has become the intellectual property covering these complex biologics, made of multiple patents on all their aspects. Biosimilar developers are therefore challenging these patents, often one by one, in court or at the PTAB level via the shorter Inter Partes Review. However even if these patents are not all over turned in court or at the PTAB in the near future, the next five years will nevertheless see the IP of seven out of the eight best-selling medicines set to expire in the US and in EU. Most likely Europe will be at the forefront in this next wave of approvals and launches as it has since 2006 when the EMA approved the first (simple) biosimilar. Doctors have since gained confidence in prescribing biosimilars as many “real-life” clinical data confirm their similar efficacy and safety than the reference biologics. Biosimilars could therefore become the fastest growing segment within Pharmaceuticals over the next decade while acting as a powerful force driving down the cost of healthcare and/or enabling more patients to gain access to some of the most sophisticated therapies.

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June 2017

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Juin  2017

 

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L'Article

LEOPOLD Marie-Hélène , Equity Analysis - Paris
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