Who We Are
The Alliance for Safe Biologic Medicines is an organization 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 the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
ASBM Shares EU Physician Survey in Paris
Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at the “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars” event hosted by AbbVie on June 10th in Paris, France.
The two-part event was webcast worldwide and featured a discussion on the scientific and regulatory challenges presented by biologics and biosimilars. Reilly presented the results of the ASBM EU Physician Survey, and also participated in a panel discussion with ASBM Steering Committee member and Co-Chair of the Global Colon Cancer Association, Andrew Spiegel.
Journal Article on ASBM EU Survey Published
The Generics and Biosimilars Initiative (GaBI) Journal published an article on the ASBM EU Survey written by Richard Dolinar, MD Chairman of ASBM and Michael Reilly, Executive Director. GaBI is an independent and peer reviewed academic journal which encompasses all aspects of generic and biosimilar medicine development and use, from fundamental research up to clinical application and policies.
To view ASBM article in GaBI, click here.
EGA Multi-Stakeholder Survey on Biosimilar Sustainability
While in Europe, Executive Director of ASBM Michael Reilly traveled to Brussels, Belgium to attend the European Generic Medicines Association’s (EGA) release of a study identifying some of the challenges to establishing a sustainable biosimilar medicines program in Europe.
The survey included multiple stakeholders including physicians, payers, pharmacists, patients and industry across seven EU countries. According to the study and the EGA’s press release any national policy framework on biosimilars should consider a variety of factors which include: targeted education of all stakeholders, incentives that encourage competition while supporting innovation, the publication of real world evidence to increase safety and efficacy, as well as transparent policies that allow for input without delaying market entry.
To learn more about the EGA study, click here.
Dr. Dolinar Presents at DIA Annual Conference
On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California.
“Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars. Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. Regulatory Policy at Merck and panelist Sonica Sachdeva, Director of Clinical Development at Dr. Reddy’s Laboratory, India.
Dr. Dolinar shared the results of the ASBM European Prescriber Survey while advocating for distinguishable non-proprietary names for biosimilars. Dr. Sachdeva reviewed how biologics and biosimilars are regulated in Eastern Asia.
View Dr. Dolinar’s presentation here.
ASBM Members Feature Biosimilars at BIO Convention
The Biotechnology Industry Organization (BIO) hosted its International Convention in San Diego, CA on June 23rd-26th.
This year’s convention featured a panel of ASBM members including:
ASBM Steering Committee member Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN); ASBM International Advisory Board member and Associate Dean of the University of Arizona College of Pharmacy, Phillip Schneider; and also ASBM International Advisory Board member, Robert Yapundich, MD.
The session entitled, “Ensuring the Safety and Commercial Success of Biosimilars in the United States,” examined how the United States can move forward to ensure patients have access to high quality, safe and effective biosimilars. Panelists discussed the impact of international naming conventions, state substitution policies and other challenges facing regulators, including lessons learned from the European experience with biosimilars.
To view BIO Conference page, click here.
IN THE STATES
Massachusetts Third State to Enact Biosimilars Substitution Bill
Governor Deval Patrick enacted biosimilars legislation on June 24th, updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the legislature.
This new law allows pharmacists to substitute a biosimilar for a brand biologic once the biosimilar is deemed to be ‘interchangeable’. The pharmacists will be required to communicate that a substitution has occurred both to the patient, as well as the prescribing physician. Importantly, physicians will also maintain the right to prohibit substitutions from occurring if the prescriber instructs otherwise in writing. The pharmacy will be required to maintain a record of each substitution for a period of at least a year.
“By ensuring that communication between physicians, pharmacists and patients remains a priority, we can monitor these complex therapies while providing the best quality and care,” concluded ASBM Chairman Richard Dolinar, MD. “We commend Governor Patrick for taking the necessary steps to protect this balance for patients in Massachusetts.”
View ASBM’s full press release here.
Pennsylvania
The Pennsylvania Senate has also recently passed biosimilars legislation. SB 405 was voted out of the Senate by a vote of 44-6 on June 24th. This legislation also addresses FDA approved ‘interchangeable’ biosimilars, and maintains the right of physicians to prohibit substitution, as well as notify the patient of the exchange. However, the language specifically requires physician notification to occur within 72 hours of dispensing, and requires record keeping for at least two years.
It is hoped the House Committee on Health will hear the bill in the fall when it reconvenes.
View legislation here.
BIO President and CEO, James Greenwood, also wrote the Philadelphia Inquirer commenting on the bill and the need for PA to pass biosimilars legislation. Greenwood, who is a former PA State legislator and Member of Congress wrote the Inquirer stating:
“Interchangeable biologics provide additional options for healing debilitating diseases. Pennsylvania lawmakers – and legislators around the country – should do their part to make certain that, when these options become available, nothing prevents patients from obtaining them.”
View Philadelphia Inquirer op-ed here.
ASBM Submits EOI to 59th WHO INN Session
In a letter addressed to Dr. Balocco, International Nonproprietary Names (INN) Manager, ASBM once again submitted an Expression of Interest (EOI) to appear before the Open Session of the 59th (INN) Consultation that will take place on Tuesday, October 14th, 2014.
On behalf of ASBM, Dr. Dolinar has twice appeared before the INN Expert Group, most recently in April 2014. The WHO is expected to publish both an Executive Summary and the next steps for a ‘Biologic Qualifiers’ (BQ) proposal by the end of July 2014.
To visit the WHO INN page, click here.
NORD Advocates for Distinguishable Naming in Letter to FDA
The National Organization for Rare Disorders (NORD) was the second large patient-focused advocacy group to write the U.S. Food and Drug Administration in the past month on the naming of biosimilars as more pressure is being placed on the FDA to establish an opinion on naming.
In the letter, NORD argues that it is particularly important for the tracing of adverse events in the disease populations it represents because many rare disease patients must prove ‘medical necessity’ for treatment and reimbursement. In addition, distinguishable names help doctors more quickly determine which medicines are best for patient, providing individualized care needed for rare diseases.
“Distinguishable names for biologics support the medical community’s vital post-approval learning curve about which medicines are best for their rare disease patients,” the letter to the FDA states.
View NORD press release and letter to FDA here.
NHMA Joins ASBM Ranks and Bolsters Physician Voice in Biosimilars Discussion
This June, ASBM welcomed the National Hispanic Medical Association and it’s president, Elena Rios, MD, MSPH.
Established in 1994, NHMA is a nonprofit association representing 45,000 licensed Hispanic physicians in the United States. NHMA’s mission is to empower Hispanic physicians and other healthcare professionals to improve the health of Hispanic populations with Hispanic medical societies, residents and medical student organizations and its public and private sector partners.
To learn more about the National Hispanic Medical Association, click here.
Upcoming Conferences:
August 13th and 14th: 4th Latin America Forum on Biosimilars, Rio de Janeiro, Brazil
August 24th and 25th: Pre-International Conference of Drug Regulatory Authorities, Rio de Janeiro, Brazil
September 18th and 19th: DIA Biosimilars 2014, Washington, DC
September 20th: European Parkinson’s Disease Association Unity Walk, Luxembourg
