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State Activity
Senate:
On 3/5/15, SB 1611 was Assigned to Executive and on 3/27/15: Rule 2-10 Committee Deadline Established as April 24, 2015.
House:
On 3/25/15: House Committee on Health Care Licenses Adopted Amendment No. 3 of HB 3519; Placed on Calendar for 2nd Reading.
BioPharma: California, Illinois propose biosimilar substitution bills
March 3
More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.
Read full article here.
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Bill Information
Defines “interchangeable” as an FDA-licensed biosimilar or a biologic that is deemed therapeutically equivalent to another biologic by FDA.
Permits dispensing of an interchangeable biological product in place of a prescribed biologic, provided that:
—the interchangeable biologic has determined to be interchangeable by FDA;
—prescriber does not indicate that substitution is prohibited (including orally);
—pharmacist informs patient of the substitution;
—pharmacist notifies prescriber within a reasonable time, electronically if possible, (and by other means if not), except when there is no FDA-approved interchangeable biosimilar or the prescription is a refill that is unchanged from the prior filling;
– Amendment No. 1 would change “a reasonable time” for a pharmacist to notify a prescriber to “within 5 days” and
—pharmacist retains record of the substitution for 5 years.
Directs the Board to maintain on a website the list of approved interchangeable products. Directs the board to adopt rules for compliance with the law.
Adopts the definitions of “biological product,” from 42 U.S.C. § 262.
Defines “interchangeable” as an FDA-licensed biosimilar or a biologic that is deemed therapeutically equivalent to another biologic by FDA.
Permits dispensing of an interchangeable biological product in place of a prescribed biologic, provided that:
—the interchangeable biologic has determined to be interchangeable by FDA;
—prescriber does not indicate that substitution is prohibited (including orally);
—pharmacist informs patient of the substitution, and the patient agrees to accept the biosimilar;
—the cost of the biosimilar is less than the cost of the prescribed biologic, except if the patient agrees to a higher cost biosimilar;
—pharmacist notifies prescriber within 5 business days, including product and manufacturer names; and
—pharmacist retains record of the substitution for 5 years.
Directs the board to adopt rules for compliance with the law.
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Archive
ASBM Writes Letter to IL Governor Urging Signature on Substitution Bill
June 19, 2015
On Friday, June 19, ASBM sent a letter to Illinois Governor Bruce Rauner urging him to sign SB 0455, which would permit biosimilar substitution. It is ASBM’s view that SB 0455 does so while appropriately reflecting the importance of pharmacist-physician communication and keeping treatment decisions the purview of the physician and patient. ASBM’s survey of 376 U.S. […]
Science for Managers
June 17, 2011
September 12-14, 2011 Kellogg School of Management 340 East Superior Street, 2M Chicago, IL Read More
Science for Managers
June 17, 2011
September 12-14, 2011 Kellogg School of Management 340 East Superior Street, 2M Chicago, IL Read More
Clinical Trials and Diverse Communities: Challenges and Opportunities for the Life Sciences Industry
June 17, 2011
June 24, 2011 Seyfarth, Shaw LLP 131 South Dearborn Street Suite 2400 Chicago, IL Read More
Personalized Medicine: Providers, Pharma, Payors and Patients
June 17, 2011
June 17, 2011 University of Illinois Chicago – Student Center East – Dearborn Room Chicago, IL Read More
Personalized Medicine: Providers, Pharma, Payors and Patients
June 17, 2011
June 17, 2011 University of Illinois Chicago – Student Center East – Dearborn Room Chicago, IL Read More
Illinois Biotechnology Fact Sheet – IBIO
June 17, 2011
Illinois has a long history of technological breakthroughs in biotechnology, chemistry, physics, computing, and communications. Illinois is home to more than 440 corporate R&D facilities and more than 200 academic, government, and nonprofit research institutions. Read More
Illinois Biotechnology Fact Sheet – IBIO
June 17, 2011
Illinois has a long history of technological breakthroughs in biotechnology, chemistry, physics, computing, and communications. Illinois is home to more than 440 corporate R&D facilities and more than 200 academic, government, and nonprofit research institutions. Read More
Illinois Biotechnology Industry Organization 2011 Government Affairs Policies
June 17, 2011
A primary element of iBIO’s work plan is to establish sound public policy at the local, state and federal levels. Read More
