Biosimilars Dodge Bullet As High Court Upholds ACA
- Jeff Overley
- IP Law360
This article discusses the recent ruling of the U.S. Supreme Court in upholding the Affordable Care Act and the impact of the ruling on the biosimilars industry. In response to challengers of the decision's 12-year data exclusivity limit for original biologics, Paul Calvo was quoted saying, "“I think they can try, but I don’t see much of an avenue to get [exclusivity] changed."
Under the law, biosimilars are expected to be available in the U.S. in either 2014 or 2015. Had the law been struck down, according to Dr. Calvo, “It would have been a real mess.”
The full article is available for subscribers at IP Law360.