Testimony to Pennsylvania House of Representatives' Health Committee

Fritz Bittenbender, Senior Vice President of External Affairs, delivered testimony supporting a pathway for patients to access lower cost interchangeable biological products.</p>

Pennsylvania House of Representatives
Health Committee Hearing House Bill 746
September 11, 2013

Good Morning:

My name is Fritz Bittenbender and I am the Senior Vice President of External Affairs at the Biotechnology Industry Organization. We represent more than 1,100 biosciences companies across the United States—many of whom have a significant presence in Pennsylvania. Our companies are working at the vanguard of healthcare, developing biologic medicines with the goal of curing many of the most complex and life threatening diseases -- including cancer, HIV, Alzheimer’s and many very rare disorders. There are over 500 biologic medicines currently being developed to fight these conditions.

I commend you for your consideration of House Bill 746 as it provides the necessary pathway for patients to access lower cost interchangeable biological products while also importantly ensuring that patients and physicians are notified of medication changes. BIO spent 4 months working with our members to develop a set of Principles that we believe should govern the substitution of biologic medicines in the states. We are pleased that HB 746 includes all 5 of our Principles and therefore ask you to support the passage of this important bill.

As you have heard in other testimony, biologic medicines are different from the traditional chemically synthesized small molecule medications that you are used to dealing with from a policy perspective. Biologic medicines emanate from living organisms and because of that biosimilars that are derived from different cell lines and separate manufacturing processes will be slightly different than the innovator products they seek to replicate. This is not a safety issue, as the FDA will require all sponsors, whether in the innovator market or the biosimilar market, to demonstrate that their products are safe and effective. However, biosimilars cannot be an exact copy of an innovator biologic the way generics medicines are copies of innovative small molecule products.

In actuality, there will be three types of biologics in the marketplace-- innovator biologics, biosimilars, and interchangeable biological products. All three types of biologics will play a critical role in the delivery of healthcare in the years to come.

When crafting the legislation, Congress understood that biosimilars could not be an exact copy of an innovator biologic; instead, they tasked FDA with the development of a heightened standard for interchangeable biological products, that will with confidence, produce the same clinical result as the reference product in any given patient. We urge that only biologics that meet the heightened standard of interchangeability should be allowed to be substituted at the pharmacy.

As an example, in Europe they do not allow product substitution at the pharmacy because they did not develop an interchangeability standard. It was recognized by policymakers at the EU that biosimilars could be too different from the innovator product to be freely substituted. Therefore, the provision in House Bill 746 that allows only interchangeable biological products to be substituted at the pharmacy is critical.

Almost as important, are the transparency measures that are in HB 746. Again biologic medicines are different than small molecule drugs in the way they interact in the body. Being that they are derived from biological processes akin to those in our own bodies, biologics are generally safe and well received by patients. However, biologics are different than small molecules in that there is a heightened risk of adverse immune reactions, and sometimes these occur after a patient has been on the product for a long time. Also, it happens infrequently but, the body can build up an immune response to the medicines that causes these medicines to stop being effective. For this reason, BIO believes that transparency is important across all three types of biologics and specifically that patients and their physicians should know what products they have received from the pharmacy regardless of whether it is an innovator product, a biosimilar, or an interchangeable biological product.

We do not ask that the patient and physician consent to the switch of an interchangeable biologic at the pharmacy but rather only that they are notified of the change. Notification, particularly in the instance of the physician, will be after the medicine is dispensed and most likely administered to the patient so it should not be seen as a barrier to competition. Furthermore, it should be noted that nothing in this legislation prevents insurance companies from employing the tools at their disposal to incentivize the utilization of biosimilars or interchangeable biosimilars. Insurance companies can and will create a robust market for biosimilars through fail first policies, step therapies and a system of tiered co-pays. Given these significant factors as well as the fact that less than 2% of biologic medicines are delivered through the retail pharmacy in Pennsylvania, it seems a stretch to claim that physician knowledge of a substitution will have a significant impact on the development of the biosimilar marketplace.

In closing, HB 746 closely follows the Principles that BIO established for the Substitution of Biologic Products and we would ask for your support in the passage of this important legislation.

I am happy to answer any questions.