"You're going to see a flood of bispecific molecules enter and advance through the clinic in the next two to three years. We're really at the early days of the platforms that are going to change the landscape."
Bassil Dahiyat, president and CEO, Xencor Inc.

"The BPCIA is not going to create a system for biosimilars that looks like Hatch-Waxman generics. The statutory intentions are very different and, for manufacturers that are thinking about whether to pursue the BPCIA route or the standard [biologics license application], I think the latter is going to look more attractive as a viable option."
Benjamin P. Falit, Harvard Radiation Oncology Program and co-author of a Health Affairs paper comparing the legislative framework governing generic medications to the laws governing biosimilars such as the the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which created a regulatory pathway for the approval of biosimilar drugs

"America's patients deserve a review process to match the cures and life-changing treatments that American scientists today are discovering."
Lamar Alexander (R-Tenn.), HELP Chairman, announcing the Senate Health, Education, Labor and Pensions Committee's launch of a bipartisan Innovation for Healthier Americans Initiative

"The change in Japan over the past half dozen years in terms of the elimination of the drug lag and the approval speed of new drugs has been nothing short of remarkable. The result is that Japanese patients no longer have to wait three to six years to receive the newest and most innovative drugs developed by global and Japanese pharmaceutical companies. These patients are receiving the benefits of the $500 billion that industry has invested in R&D over the past decade."
Ira Wolf, Japan's representative of the Pharmaceutical Research and Manufacturers of America