GPhA Applauds Interchangeable Biologics Access Legislation Proposed in Georgia
Published Online: Tuesday, February 11, 2014
WASHINGTON, DC (February 11, 2014) —The Generic Pharmaceutical Association (GPhA) supports SB 370, introduced by pharmacist and Sen. Buddy Carter, R.Ph., because it will allow unimpeded patient access to affordable, life-saving interchangeable biologics . The bill mirrors current pharmacy practice for interchangeable generic substitution language, and is aligned with Food and Drug Administration (FDA) definitions.
“While there is no ‘one-size-fits-all’ model for states, one can look to the law enacted in Florida, and now, the bill under discussion in Georgia,” said Ralph G. Neas, President and CEO of GPhA. “GPhA applauds efforts in Georgia to foster timely access to interchangeable biologics. This bill takes appropriate steps to limit roadblocks to these medicines and avoids unneeded mandates for notifying physicians that extend beyond current practice. The proposed bill in Georgia preserves the intent of the Biologics Price Competition and Innovation Act (BPCIA) — an approach backed by science and precedent.”
Last year, legislation that would erect obstacles to interchangeable biologic substitution was introduced in 19 states in 2013, blocked in 11, enacted with significant amendments in three states, and enacted with Amgen and Genentech-backed provisions intact in only one state (North Dakota).
“As the promise of biosimilars becomes reality in the U.S., state legislatures are a key piece of the regulatory roadmap. At the same time, FDA guidance and international naming conventions must align so that the safety and efficacy of these medicines is not undermined and patient access remains timely,” said Neas.
Like any association that operates by consensus, GPhA sometimes has individual member companies who have a different perspective on individual issues.
Amgen has discontinued its studies on rilotumumab in advanced gastric cancer after an increased number of deaths were reported among patients receiving rilotumumab and chemotherapy, compared with those only undergoing chemotherapy.
Generics saved $239 billion in 2013 (a 14% increase in savings from 2012) and more than $1.46 trillion over the recent decade. Further, the Express Scripts 2013 Drug Trend Report issued in 2014 shows that since 2008, the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half.
The FDA today approved a new indication for an oncology drug that significantly reduces ovarian cancer disease progression.