September 27, 2014 Comments Off on Advances in drug development & approvals landscape, and industry partnerships Posted in: General Biotechnology The Biotechnology Industry Organization (BIO) held its 2014 Annual Convention at the San Diego Convention Center, CA (June 23-26, 2014). This event was attended by more than 15,660 industry leaders that included 2,500 Chief Executive Officers (CEOs), several U.S. Governors, and representatives from 50 states and 70 countries. The BIO Exhibition saw presence of over 1,800 exhibitors with 55 state and international pavilions. Additional features of the Convention comprised 192 company presentations, 800 speakers and 160 sessions in 9 specialty forums and 8 educational tracks and 29,000+ one-on-one partnering meetings between 3,100+ companies. Keynote speakers featured Sir Richard Branson and Former Secretary of State Hillary Rodham Clinton.
September 27, 2014 Comments Off on What the patent dance of the Biosimilars Act means for biosimilars Posted in: General Biotechnology There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US.
