American Cancer Society
Cancer Action Network
5555 Frantz Road
Dublin, Ohio 43017
Testimony of the American Cancer Society Cancer Action Network
Before the House Health & Aging Committee
Regarding HB 505
April 20, 2016
Good morning. My name is Jeff Stephens and I am the Ohio Government Relations
Director for the American Cancer Society Cancer Action Network. Thank you
Chairwoman Gonzales and members of the House Health & Aging Committee, for the
opportunity to provide testimony in support of HB 505 today. The American Cancer
Society Cancer Action Network supports this legislation, which updates current Ohio
substitution laws to address biological products while enhancing access to life saving
medicines and facilitating communication among patients and their health care providers.
To put our comments into context, it is important to understand the burden of cancer.
Cancer has a profound impact on the lives of Ohioans. One in two men and one in three
women will be diagnosed in their lifetime. The American Cancer Society estimates that
in Ohio this year 66,020 new cases of cancer will be diagnosed and 25,510 cancer deaths
ACS CAN’s support is for this legislation is based on three principals. 1) Consent. We
believe physicians should have the ability to withhold or provide consent for biosimilar
substitution. 2) Notification and Recordkeeping. When there is an interchangeable
biosimilar, the prescribing physician should be notified of the actual biologic dispensed,
to ensure an accurate and enduring patient medical record. 3) Safety and
Interchangeability. The Food and Drug Administration (FDA) is the sole entity
responsible for ensuring the integrity and designation of “interchangeable biosimilars”.
FDA deemed interchangeability will be cataloged in the “Purple Book” and this book
should be the sole reference for products suitable for interchange.
The development of biologic drugs has provided cancer patients and their physicians with
access to improved therapeutic options. Biologic drugs are some of the most expensive
cancer drugs on the market today; however, as generics have done for small-molecule
drugs, interchangeable biosimilars have the potential to increase price competition on
older biologic drugs, and result in lower cost burdens for cancer patients. In order for
biosimilars to provide increased access and affordability through competition, state
pharmacy laws have to be amended to create the ability for biosimilar substitution at
American Cancer Society. Cancer Facts & Figures, 2016. Atlanta: American Cancer Society, 2016.
As biosimilar policies are developed, they must focus on ensuring the safety and efficacy
of all biologic drugs, whether innovator or biosimilar, and policies must also ensure
access and affordability of biosimilars for cancer patients. The FDA has the responsibility
to ensure the safety and efficacy of all drugs and biologics. So far, three biosimilars have
been approved by the FDA. Over 10 additional applications have been submitted with
decisions expected in 2016 and many more are in the development pipeline.
When interchangeable biologics are approved by the FDA, patients and their providers
will need a safe and transparent process by which they can receive access to these
medicines to treat their diseases, and pharmacists also need a clear standard way to
substitute biological products with those that the FDA has deemed “interchangeable” to
the products prescribed. By creating a new pathway for biologic substitution where none
currently exists in Ohio, this legislation enhances patient access to new and potentially
less costly medications.
Thank you, Chairwoman Gonzales, for the opportunity to testify on this important policy.
We urge the committee’s support of this legislation.