A letter to our Arizona Legislators on Arizona’s Biosimilars Bill
Dear Arizona Legislators,
As innovators within Arizona’s biosience and healthcare community and members of the Arizona Bioindustry Association, we get to see many exciting new healthcare developments including new biologic therapies that are being approved and coming to market. With each one, we have a great opportunity to bring more hope to more patients.
With the passage of the Affordable Care Act and the work being done at the FDA, we will also see a day in the not so distant future when biosimilars will also be available in the United States. These new therapies will help us to lower healthcare costs and offer doctors and their patients a broader range of life saving and life sustaining products to choose from.
This week, on February 20th at 2 PM, Senate Bill 1438 will be heard in the Health and Human Services Committee of the Arizona Senate. The bill updates Arizona’s Pharmacy Act and sets the procedure by which a pharmacist can substitute an interchangeable biosimilar for a patient. The bill is sponsored by Senator Kelli Ward, MD and co-sponsored by Senator Nancy Barto and Representative Kate Brophy McGee.
Key aspects of the bill include:
- Only an interchangeable biosimilar can be substituted.
- Physicians retain the right to use “Dispense As Written”.
- Patients are notified of the substitution.
- After the substitution has been made, the pharmacist must send the substitution information to the physician within 72 hours.
- The pharmacist must maintain the record for 7 years.
At this time, there are no interchangeable biosimilars that have been approved by the FDA. When they are available, we want to ensure that Arizonans have full access to this option as soon as it is available. That’s why Arizona’s legislators are proactively moving this bill forward so that when the FDA is ready, so are we.
Biosimilars and generics are not the same thing. Even with the very tight tolerances that we use to keep all biologics as consistent as possible, slight variances exist since biologics by their very nature are derived from live organisms. In the case of the new biosimilars, since they will be developed from new cell-lines, there will be some slight variation. In this new age of precision medicine, it is possible that these slight variations could lead to different patient responses during therapy – either more effective or less effective – and the way to ensure that the patient gets the best possible care is to ensure that their physician is kept in the loop on every possible variable while making the products accessible to patients.
Together as Arizonans, we come from industry, research institutes, the medical profession, and as patients and patient advocates to support SB 1438 and to help Arizona open its doors to both new healthcare innovations and new healthcare savings in the area of interchangeable biosimilars as they become available.
How you can get involved:
If you would like to be part of the process of passing this important legislation, here are some things you can do:
- Attend the Health and Human Services Committee of the Arizona Senate on Wednesday February 20, 2013 at 2 PM.
- Sign in to share your comments or request to speak: the https://www.azbio.org/advocacy/request-to-speak-instructions
- Sign on to the letter above which will presented by AZBio on behalf of members of our community. You can do this by emailing AZBio with your name, the name of your institution, practice or company, and your city/town.
Moving our industry forward includes helping to shape the laws that govern it. We hope that you will take this opportunity to be part of the legislative process.
— Joan Koerber-Walker, President and CEO, AZBio