The document discusses interchangeable biosimilars and the Arthritis Foundation's position on their substitution. The Foundation supports a policy requiring that the prescribing physician be notified and communicated with about any substitution of an interchangeable biosimilar for the originally prescribed biologic medication. This is important considering the complex nature and specialized use of biologics to treat serious medical conditions. Prescriber communication is seen as essential to ensure the safe use of interchangeable biosimilars and proper management of the patient's treatment. The presentation provides background on the Foundation's advocacy in this area and the increasing state-level legislative activity around biosimilar substitution policies.

1. SPRING POLICY FORUM

2. About iBio
Champions the life sciences in Illinois and the Midwest
MISSION
•To make Illinois and the surrounding Midwest one of the world’s top life sciences
centers
•A great place to do business
•A great place to grow new business involving advanced technology
WORK PLAN
•Promote sound public policy at the local, state, and federal levels
•Improve Illinois’ and the Midwest’s ability to create, attract, and retain businesses
•Through the iBIO Institute, orchestrate industry involvement to help solve America’s
math and science education crisis

3. Thank you

4. BIO Principles for Substitution of Biosimilars
for Innovator Biologic Products
4
• Substitution should occur only when the FDA has
designated a biologic product as interchangeable
• The prescribing physician should be able to prevent
substitution, i.e. DAW
• The patient should, at a minimum, be notified of the
substitution
• The prescribing physician should be notified of the
substitution
• A record of the substitution must be kept by the pharmacy
for a set period of time
• Substitution should occur only when the FDA has
designated a biologic product as interchangeable
• Substitution should occur only when the FDA has
designated a biologic product as interchangeable
• The prescribing physician should be able to prevent
substitution, i.e. DAW
• The prescribing physician should be able to prevent
substitution, i.e. DAW
• The patient should, at a minimum, be notified of the
substitution
• The patient should, at a minimum, be notified of the
substitution
• The pharmacist should communicate to the prescribing
physician when a substitution is made
• The pharmacist should communicate to the prescribing
physician when a substitution is made
• A record of the substitution must be kept by the pharmacy
and the physician for a set period of time
• A record of the substitution must be kept by the pharmacy
and the physician for a set period of time

5. The Arthritis Foundation and
Interchangeable Biologic Products
Michele Guadalupe
VP of Advocacy and Public Policy
Heartland Region

6. Our Strategic Pillars:
Advocacy and Access
Our Strategic Pillars – Advocacy and Access
•Strong federal advocacy in Washington DC
•Increasing state level focus and leadership in
nontraditional arenas – where barriers are occurring
•Access to care as the centerpiece –urgent, impactful,
relevant, and often outside the regulatory realm
•Leverages and amplifies voices of 90,000+ e-
advocates
•AF can and should be THE leader – the champion
for the issues that matter most

7. Why We Care About Biologics

9. Our Position on Biosimilars
“In any instance of an interchangeable biologic
product substitution for a biologic medicine,
prescriber communication is essential.”

10. We Support a Prescriber
Communication Requirement Because:
Interchangeable biologic products, like biologics, will be used to treat complex, rare, or chronic
medical conditions.
The prescriber must know of an interchangeable biologic product substitution in order to
appropriately assess the patient’s experience and further treatment options.
Interchangeable biologic products will require a difficult or unusual process of delivery to the
patient in preparation for infusion or injection. Handling, storage, inventory or distribution of the
drug is not typically available at retail pharmacies.
Interchangeable biologic products will require significantly enhanced patient education,
management or support, beyond those required for traditional dispensing at a community or retail
pharmacy, before and/or after administration of the drug.
Interchangeable biologic products are complex medications derived from living sources – not
simple generics produced through chemical processes.
Prescribers and pharmacists must work collaboratively to ensure the protection of the patient!

12. Where Have We Been…

13. States with Enacted Biosimilar Legislation
Green = Enacted
Purple = Vetoed
Red = Enacted with Sunset
None in Alaska or Hawaii

14. Where Are We Going…

15. Blue = Introduced
Green = Enacted
None in Alaska
Hawaii is Workgroup
State Biosimilar Legislation/Regulation – 2015
32 Bills in 21 States

16. The Pathway Just Became Urgent…

17. Michele Guadalupe
VP of Advocacy & Public Policy
Arthritis Foundation, Heartland Region
(312) 880-4736
mguadalupe@arthritis.org
Thank You!