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State Activity
2015-2016 Session — Convene: 12/1/14 and Adjourn: 11/30/16
5/12/15: Senate Committee on Appropriations has scheduled the bill for a hearing on May 18 at 10:00 am (1:00 pm ET). This is the agenda.
4/13/15 – Hearing Scheduled with Senate Committee on Business, Professions and Economic Development at 1:00pm
Read the ASBM letter to bill sponsor Sen. Jerry Hill here.
BioPharma Reporter: California, Illinois propose biosimilar substitution bills
By Zachary Brennan
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 the full article here.
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Bill Information
Defines “interchangeable biological product” as a biological product determined to be interchangeable by FDA or a product that has been deemed therapeutically equivalent by FDA.
Permits dispensing of an interchangeable biological product in place of a prescribed biologic, provided that:
—prescriber does not indicate that substitution is prohibited;
—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;
—the cost of the substituted biologic is lower for the patient; and
—pharmacist notifies the patient.
Establishes that a pharmacist who substitutes a biosimilar is not subject to greater liability than would be incurred in filling the biologic prescription.
Directs the Board to maintain on a website the list of approved interchangeable products.
Makes section applicable to Medi-Cal patients.
Specifies that the law does not prohibit plans from imposing utilization controls, such as prior authorization.
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Archive
CA Governor Brown Signs Biosimilars Bill
October 6, 2015
On October 6, California Governor Edmund “Jerry” Brown signed into law SB 671, which permits pharmacists to substitute an interchangeable biosimilar in place of its reference product, provided the pharmacist communicates the substitution to the physician within five days time so that an accurate patient record is maintained, and the physician has not indicated “do not […]
California Industrial Biotechnology Conference 2011
June 17, 2011
October 4-5, 2011 BayBio and BIOCOM Crowne Plaza Cabana Palo Alto, CA Read More
Bioprocessing Facilities 2011 Conference
June 17, 2011
August 8-9, 2011 San Diego Hilton Mission Bay San Diego, CA Read More
Biotech Demystified, The science behind the business
June 17, 2011
June 27-29, 2011 UC San Diego, Rady School of Management La Jolla, CA Read More
2009 Report on California’s Biomedical Industry
June 17, 2011
California’s biomedical industry has grown organically from ideas first germinated in the state’s universities. Through technology transfer, entrepreneurial commitment and investor financing, basic science discoveries have led to breakthrough technologies to better understand, diagnose, treat and cure a broad range of medical disorders. Read More
Reps. Eshoo, Inslee, and Barton Introduce Pathway for Biosimilars Act
June 17, 2011
The bill creates a process for approval of “biosimilars” or “follow-on biologics” while protecting patient health and safety, lowering health care costs, and providing adequate incentives for innovation. Representatives Eshoo and Inslee were the lead sponsors of two separate biosimilar bills during the 110th Congress, and now have one bill with Rep. Barton, ranking member […]
Reps. Eshoo, Inslee, and Barton Introduce Pathway for Biosimilars Act
June 17, 2011
The bill creates a process for approval of “biosimilars” or “follow-on biologics” while protecting patient health and safety, lowering health care costs, and providing adequate incentives for innovation. Representatives Eshoo and Inslee were the lead sponsors of two separate biosimilar bills during the 110th Congress, and now have one bill with Rep. Barton, ranking member […]
Biotech generics: Handle with Care
June 17, 2011
One somewhat overlooked element of the Obama administration’s proposed federal budget is its desire to create the first regulatory process for government approval of so-called “follow-on biologics,” or generic versions of drugs manufactured by living organisms. These medicines are often used in treatments such as cancer, anemia, psoriasis and rare diseases, where little room for […]
