Re: Support of HB 746-Biosimilars

Thank you for providing this opportunity to speak about this important issue.

My name is Andrew Spiegel.  I am the Executive Director of the Global Colon Cancer Alliance. The Global Colon Cancer Alliance (GCCA) is the voice for colon cancer patients worldwide. Before running the GCCA, I was CEO and a founding member of the US based Colon Cancer Alliance, the oldest and largest national colorectal cancer patient advocacy organization.  The GCCA’s mission is to effectively address issues and provide information surrounding colorectal cancer to clinicians, patients and caregivers across the globe.  The Global Colon Cancer Alliance is uniting people from all corners of the world in the fight against colon cancer and is effectively increasing awareness, earlier diagnosis and access to treatment of a disease that kills more than 600,000 people worldwide annually.

I personally know the impact of cancer.  In 1999 I lost my mother to colon cancer two days after losing my father to pancreatic cancer.  I was only 35 years old. At the time, there were very few treatments for these cancers, and today, these diseases remain among the top killers of Americans from Cancer. In fact, many do not realize that Colon Cancer is the second leading cause of cancer death in the U.S. with 1.2 million Americans living with the disease and 1 out of 20 getting it in their lifetime. Pancreatic cancer is one of the fastest growing, and most deadly cancers in the US. Cancer is an epidemic in this country affecting 1 out of every 2 men and 1 out of every 3 women. These two diseases alone account for more than 20 billion dollars in treatment costs annually.

While we wish that preventative methods alone were sufficient to defeat colon cancer, this is currently not the case.  Biologic medicines offer such promise and enable patients to live longer, healthier lives.  Since the introduction of biologic medicines, the average life expectancy of the metastatic colon cancer patient has almost tripled. Because these medicines have been shown to significantly improve the survivorship rates, the Global Colon Cancer Alliance has a vested interest in seeing biosimilar medicines introduced to the U.S. market. Lower cost medications means more access and more lives saved.

Yet we recognize the inherent safety challenges associated with this class of medicines and therefore, the issue of substitution has been a new challenge for policy-makers, such as you.

As you know, biologics are highly complex, advanced prescription medicines.  Unlike drugs derived from chemicals, biologics are manufactured using a unique process with living cells and for this reason no two biologics made from different cell lines are ever identical. When attempting to replicate biologics, their “copies,” known as biosimilars, are similar to, but not exact versions of the biologic they aim to replicate and are often mistakenly referred to as “generics.” Even the smallest difference in the structure of a biologic medicine and its attempted copy can have a significant impact on a patient.

That is why the Global Colon Cancer Alliance appreciates the opportunity to contribute a patient-centered viewpoint to the discussion regarding the biosimilar regulatory pathway.  In October of 2012, the Alliance for Safe Biologic Medicines (ASBM) released key principles that should be included in any formal policy recommendation.  As a founding Member of ASBM and an active Steering Committee member, we support these principles and believe that building policy around these common sense recommendations will help ensure patient safety without delaying the introduction of biosimilars.  We support the measures in HB746 because they track the ASBM principles by endorsing substitution of biosimilars as long as:

(1) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed product for the indicated use.

(2) The prescriber does not designate verbally or in writing on the prescription that substitution is prohibited.

(3) The person presenting the prescription provides written consent for such substitution.

(4) The pharmacist notifies the prescriber in writing and as soon as practicable but no later than 72 hours after dispensing.

(5) The pharmacy and the prescriber retain a written record of the biosimilar substitution for a period of no less than five years

This legislation enhances the communication between pharmacists and physicians ensuring that doctors and pharmacists share a awareness for the exact medicine being taken, a practice that is especially important when it involves biologics.  This is a best practice and not much different than the process pharmacist practice today to ensure that patients are receiving the medicines that will serve them most effectively when they fill their prescriptions. We’ve come a long way in providing access to lifesaving drugs to colon cancer patients.  We want to ensure that these efforts continue as biosimilars are introduced and above all else, we must ensure that patient safety and welfare is the priority.  The last thing a cancer patient should have to worry about is the quality and safety of drugs prescribed by their physician. It is the patient’s right to know, and the physician’s duty to know when a biosimilar has been substituted for a prescribed biologic.

Thank you for taking the necessary steps to make patient safety a priority in Pennsylvania. We have supported the FDA in its mission to safely bring biosimilars to the U.S. and we support your efforts in my home state of Pennsylvania with HB 746.