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State Activity
2015 Session: Convene: 2/2/15 and Adjourn: 7/11/15
Senate Health Care Committee has scheduled the bill for a work session on April 20.
SB 147 Referred to Senate Committee on Health Care on 1/20/15 and held public hearing on 3/4/15
HB 2026 Referred to House Health Care on 2/24/15 and held public hearing on 3/16/15
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Bill Information
Redrafts the current biosimilar substitution law at § 689.522.
Defines “interchangeable” as meeting the standards in 42 U.S.C. § 262(k)(4).
Permits substitution of a biologic, provided that:
—FDA determined that the biosimilar interchangeable with the prescribed biologic;
—prescriber does not indicate that substitution is prohibited;
—pharmacist informs the patient of substitution;
—pharmacist notifies prescriber within a reasonable time, electronically if possible (and by other means if not), except when the prescription is a refill that is unchanged from the prior filling (removes current sunset date);
—pharmacist retains a record of the substitution for 3 years;
Directs the Board to maintain on its website a list of approved interchangeable products.
Directs the Board to adopt by rule definitions for the terms “biological product” and “interchangeable” consistent with 42 U.S.C. § 262.
Directs pharmacies to post a sign stating “This pharmacy may be able to substitute a less expensive drug or biological product that is therapeutically equivalent to or interchangeable with the one prescribed by your doctor, unless you do not approve.”
Repeals the current biosimilar substitution law at § 689.522, and instead amends the generic drug substitution law at § 689.505.
Permits substitution of a biologic, provided that:
—prescriber does not indicate that substitution is prohibited;
—the biosimilar product is interchangeable with the prescribed biologic;
—if the prescriber is not available for consultation, the biosimilar will provide essentially the same efficacy and toxicity as the prescribed biologic;
—pharmacist labels the container with the common name of the dispensed biologic;
—substitution would not result in increased cost to purchaser;
—pharmacist retains record of the substitution for 3 years;
Requires pharmacists to dispense the lowest cost biologic, if the prescriber prescribes a biologic by a common name.
Requires pharmacies to post a sign stating “This pharmacy may be able to substitute a less expensive drug or biological product that is therapeutically equivalent to or interchangeable with the one prescribed by your doctor, unless you do not approve.”
Establishes that substitution does not constitute the practice of medicine, and does not constitute evidence of negligence if made within reasonable and prudent practice of pharmacy. Failure of prescriber to prohibit substitution would not constitute evidence of negligence unless prescriber knows about a pertinent health condition of the patient.
Directs the Board to adopt by rule definitions for the terms “biological product” and “interchangeable” consistent with 42 U.S.C. § 262.
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Archive
ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars
December 20, 2023
On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly […]
June 16, 2011
Office of Governor John Kitzhaber Oregon Bioscience Association Oregon Health Authority Oregon Health & Science University Resource Directory Oregon Life Sciences Oregon Medical Association Oregon Nanoscience and Microtechnologies Institute Oregon State Legislature Oregon State University – Biotechnology Oregon Translational Research and Drug Development Institute
Oregon Economic Impact Study
June 16, 2011
A new economic impact study shows biotechnology, life sciences and medical research contribute billions of dollars in direct revenue to Oregon’s economy, and local biotech workers earn higher wages. Read More
Oregon Economic Impact Study
June 16, 2011
A new economic impact study shows biotechnology, life sciences and medical research contribute billions of dollars in direct revenue to Oregon’s economy, and local biotech workers earn higher wages. Read More
Economic Impact of Oregon Health Sciences University
June 16, 2011
Oregon Health & Science University (OHSU) is the state’s only academic health center, and is among the state’s largest healthcare providers, educational institutions, research centers and employers. OHSU’s health and economic impacts are substantial, and while its activities are centered in the Portland metropolitan area, its impact reaches throughout the state. Read More
2010 Oregon Bio Annual Report
June 16, 2011
The Oregon Bioscience Association is pleased to share industry updates, benchmarks, strategy and milestones in its 2010 Annual Report on Community, Collaboration and Commercialization. Throughout 2010, Oregon’s bioscience industry remained an economic bright spot. Despite this less than ideal environment, Oregon Bio made steady, measurable progress in building a solid financial foundation for future growth. […]
Bio in Oregon
June 16, 2011
Oregon’s bioscience industry is recognized for its contributions to the health and well-being of our people, and there is a growing awareness of its positive impact on our state’s economy and on each community in which bioscience companies and institutions operate. Read More
