ARTICLES BY TERRI STEWART

• What Does The U.S.-Mexico-Canada Agreement Mean For Biosimilars?

  10/30/2018

  The proposed text of the U.S.–Mexico–Canada Agreement (USMCA) is intended to replace the North American Free Trade Agreement (NAFTA), which has been in place since the mid-1990s. There have been some very strong reactions. Is the USMCA “an important step in bringing Mexico and Canada closer to high U.S. standards” or a crushing blow to patients that will “stifle biosimilar competition"? As with most things, the details will matter, and of course the House and Senate must still approve the agreement. It’s important to consider 1) Whether the 10-year exclusivity impacts the filing of biosimilar applications, 2) What this change means in terms of the prioritization of some medicines from a public policy standpoint, and 3) The impact the agreement has on efforts to make biosimilars more accessible in the U.S.

• Could Naïve Patients Be The Key To U.S. Biosimilar Success?

  9/26/2018

  A decade after the primary negotiations that resulted in the BPCIA, it is safe to say the promise of biosimilars is yet to be realized. As it turns out, perhaps naivety, in a clinical sense, is the solution.