Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
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Biosimilar Development Lists Top 5 Developments of 2016
On December 29th, Biosimilar Development presented its “Top 5 Biosimilar Developments in 2016”. In the piece, biosimilars reporter Anna Rose Welch offers her observations about key trends in biosimilars regulation and marketing.
These include the increasing acceptance of extrapolation with infliximab biosimilars among regulators, as well as the accumulation of more data supporting their safe switching.
Ms. Welch also highlights recent moves by insurers CVS and UnitedHealth to replace two biologics with their biosimilars in their 2017 formularies, which could impact the ability of patients and physicians to control their treatment decisions regarding biologic medicines.
Read the entire article here. |
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FDA Finalizes Guidance on Pharmacology Data for Biosimilar Sponsors
On December 29th, the FDA finalized its Guidance for Industry entitiled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”. The final version of the Guidance is very similar to the draft version issued in May of 2014.
The guidance offers nonbinding recommendations to biosimilar sponsors on matters including suggestions on exposure and response assessment, pharmacokinetic (PK) and pharmacodynamic (PD) modeling, analytical and quality similarity, addressing safety and immunogenicity concerns, selection of study population and product dose.
The Guidance may be read here.
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Ohio Enacts Biosimilar Substitution Law
On December 19th, Ohio Governor John Kasich signed HB 505 into law. The bill had unanimously passed the House on May 11th and the Senate on December 14th.
The law permits a pharmacist to substitute an interchangeable biosimilar in place of its reference product, provided the prescribing physician is notified which product-the originator or the biosimilar- was ultimately dispensed to the patient.
26 states and Puerto Rico have passed similar subtitution laws over the past three years.
ASBM held an educational forum in May 2016 at Ohio State University’s College of Pharmacy and Medicine in Columbus, Ohio, led by ASBM Advisory Board Chair Philip Schneider, who spent 30 years on the school’s faculty and who testified in support of HB 505 on April 20th. The bill’s sponsor, Rep. Stephen Huffman, was in attendance and answered questions about the bill.
ASBM extends our thanks to our many members in the patient community who urged Ohio lawmakers to support HB 505.
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wASBM’s Michael Reilly Interviewed in PBH Health’s Elements Magazine
On December 15th, independent pharmacy organization PBA Health published an article “Biosimilars on the Rise: The New Era of Biosimilar Drugs”, in its quarterly magazine Elements. PBA Health is a pharmacy services organization that serves more than 2,500 independent community pharmacies, independent retail chains and institutional pharmacies across the country.
ASBM Executive Director Michael Reilly was interviewed for the piece, in which he discussed the expected savings of biosimilars relative to generics:
“It’s important to realize that the cost-savings that will result from biosimilars are going to be significantly different than what you see with generics,” Reilly said. “With generics, you may see an 80 percent mark down right away, but with biosimilars, you generally see around the 15 percent mark.”
Mr. Reilly also addressed the status of “interchangeable” biosimilars- a class of biosimilar that will produce the same results as the originator biologic upon which it is based, with no additional risks to a patient who has been switched to it from the originator product. Only an “interchangeable” biosimilar can be substituted in place of its reference products by a pharmacist. Currently, none of the four biosimilars approved in the U.S. are classified as “interchangeable”.
“It’s important to note that the FDA has yet to put out guidance as to what will determine if something is approved as an interchangeable, therefore no one has submitted an application for an interchangeable,” said Reilly.
Read the full article here.
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Patients, Physicians Brief Alaskan Lawmakers on Biosimilars
On December 13th ASBM Members Andrew Spiegel of the Global Colon Cancer Association and Steve Marmaras of the Global Healthy Living Foundation partcipated in a 2-hour briefing and breakfast for Alaskan legislators.
Several prescribers of biologics, including three of Alaska’s seven rheumatologists and a dermatologist, also participated in the hearing and expressed their strong support for communication in the event of a pharmacy-level biosimilar substitution. Industry representatives also gave a presentation about the basic science and key policy considerations of the biologics and biosimilars they manufacture. |
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UPCOMING BIOSIMILAR EVENTS
2017 Gastrointestinal Cancers Symposium
San Francisco, California – January 19-21
World Affordable Medicines Congress
Barcelona, Spain – February 7-8, 2017
Biosimilars LATAM
Sao Paulo, Brazil – February 16-17, 2017
29th Annual DIA EuroMeeting
Glasgow, Scotland – March 29-31, 2017
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