iBIO Spring Policy Forum

SPRING POLICY FORUM

About iBioChampions 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

Thank you

BIO Principles for Substitution of Biosimilars for Innovator Biologic Products

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• 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

The Arthritis Foundation and Interchangeable Biologic Products

Michele GuadalupeVP of Advocacy and Public Policy

Heartland Region

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

Why We Care About Biologics

Our Position on Biosimilars

“In any instance of an interchangeable biologic product substitution for a biologic medicine,

prescriber communication is essential.”

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!

Where Have We Been…

States with Enacted Biosimilar Legislation

Green = EnactedPurple = VetoedRed = Enacted with Sunset

None in Alaska or Hawaii

Where Are We Going…

Blue = IntroducedGreen = Enacted

None in AlaskaHawaii is Workgroup

State Biosimilar Legislation/Regulation – 201532 Bills in 21 States

The Pathway Just Became Urgent…

Michele GuadalupeVP of Advocacy & Public Policy

Arthritis Foundation, Heartland Region(312) [email protected]

Thank You!