GPhA Applauds Interchangeable Biologics Access Legislation Proposed in Georgia

Published Online: Tuesday, February 11, 2014
Follow Pharmacy_Times:
PRESS RELEASE

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.
Related Articles
Priced at approximately $178,000 for 2 courses of treatment, Blincyto will be one of the most expensive cancer medications on the market.
The Generic Pharmaceutical Association welcomes the FDA’s proposed rule to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.
The Generic Pharmaceutical Association has serious concerns about the unbalanced structure of the Trans-Pacific Partnership agreement in its current form.
GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.
Latest Issues
$auto_registration$