Biotech Wins Protection From Biosimilars

Love is the power to see similarity in the dissimilar.

– Theodor Adorno

When President Obama signed the healthcare reform legislation into law, he also handed a major victory to biotech companies.

Unless you’ve been stranded on a deserted island with only a volleyball for company, you’re aware that most of the press and analysis surrounding this legislation focused on insurance reform.  However, there is also a provision that grants 12 years of data exclusivity for new biologics.  Translation:  Biosimilar products (a.k.a “generic biologics” or “follow-on biologics”) will have a long delay before they can enter the market.

Again, this is a major victory for the biotech industry because: 1) it is significantly longer than protections in previously proposed pieces of legislation and 2) it had received direct criticism from Obama.  Not surprisingly, the Biotechnology Industry Organization (BIO) President and CEO, Jim Greenwood, had some positive things to say about the legislation.

12 years.  No one knows exactly how this will affect the future of biologic development (and if someone tells you that they know, keep an eye on your wallet), but it certainly re-shapes the landscape.

Nota bene – Not everyone fared so well:  Medical device manufacturers will pay a 2.3 percent tax on some devices starting in 2013 with no apparent revenue boost from the legislation.