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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| ASBM Presents on Naming at World Biosimilar Congress USA 2018
On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers.
ASBM Advisory Chair Philip Schneider gave a presentation entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names.
Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing this need. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC and his April 30th meeting with WHO in Geneva, emphasizing the importance of the WHO assuming a leadership role on this issue:
“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”
View Dr. Schneider’s presentation here.
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| ASBM Meets with Patient Groups Worldwide at IAPO Conference
On May 23rd-24th, ASBM attended the International Alliance of Patients’ Organizations 8th Global Patients Congress.
The meeting was attended by approximately 80 different patient groups and 130 participants from around the globe which convene on a number of health topics—including sessions on how best to engage regulators worldwide and a 101 on biosimilar medicines. ASBM also hosted a booth which highlighted the importance of the harmonization of naming schemes for biologics and biosimilars and included a poster presentation of results from physicians in 12 countries surveyed by ASBM. View the poster here.
At the meeting ASBM Steering Committee member and Global Colon Cancer Association Executive Director, Andrew Spiegel, was named as the Chair-elect to be IAPO Chairman in August of 2020.
“We send ASBM’s congratulations to Andy for his recognition as a top notch global patient advocate and look forward to his leadership at IAPO,” stated Dr. Madelaine Feldman, ASBM Chair.
ASBM Welcomes New Member Esperantra
At the 2018 IAPO meeting, ASBM engaged with many patient organizations and as a result would like to welcome Esperantra to ASBM membership.
Esperantra is a non-profit organization created for the purpose of contributing to the reduction of cancer mortality in Peru by improving the quality of life of cancer patients, and advocating for equality in access to quality treatments and to innovative care. Esperantra is the first organization of its kind to provide information and support, and to advocate on behalf of cancer patients through its different programs. Their mission is to inform, educate and empower people to achieve a timely diagnosis through prevention programs and to access treatments to control the disease.
Through the meeting of Director Karla Ruiz De Castilla Yabar, ASBM learned that Esperantra has been following regulations in their country on biologic medicines and been active in giving lectures on the issue.
We welcome Esperantra to ASBM’s membership—especially as we tackle such global issues as the naming of biologics and biosimilars,” stated ASBM Executive Director, Michael Reilly. “All patients, no matter what continent they live, should be able to benefit from knowing that their medicines are safe and effective. The harmonization of biologic naming will benefit all patients, no matter where they are being treated.”
Learn more about Esperantra here.
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| ASBM Presents at World Health Professions Regulation Conference
On May 17th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland.
ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S.
The findings were presented by ASBM’s International Advisory Board Chair, Philip J. Schneider, MS, FASHP, FASPEN, FFIP; who co-authored the abstract with ASBM Executive Director, Michael Reilly, Esq.
The conference, in its fifth year, is sponsored by the World Health Professions Alliance, an international organization representing dentists, nurses, pharmacists, physicians, and physical therapists.
Read more about WHPRC 2018 here.
View the poster here.
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| FDA Approves Tenth Biosimilar
On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
The FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. Retacrit has been approved as a biosimilar, not as an interchangeable product.
Read more about the FDA’s approval here.
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| ASBM Chair Testifies in Support of Bill Forbidding Mid-Year Formulary Changes for Stable Patients
On May 10th, ASBM Chair Madelaine Feldman testified in support of Illinois House Bill 4146, which essentially forbids mid-year formulary change on a patient who is stable on their medicine. Other proponents included the Coalition of State Rheumatology Organizations, an ASBM member, and patient advocacy groups including the Arthritis Foundation.
The bill passed the Senate on May 25th and has been placed on the House Calendar of Order for Concurrence with Senate Amendments.
Read more about HB 4146 here.
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U.S. State Substitution Update
Currently, 43 states and Puerto Rico have now enacted laws permitting the substitution of an interchangeable biosimilar in place of a prescribed biologic. Two additional bills sit on the desks of the Governors of Alaska and Connecticut awaiting signature. Each state’s law provides that the pharmacist should communicate to the prescribing physician in a timely manner which product was dispensed — the originator or the biologic. Physicians also retain the ability to prevent a substitution they deem medically inappropriate for their patient. States with recent activity include:
Connecticut: On May 22nd, the House transmitted S 197 to Governor Dannel Malloy for signature.
New Hampshire: On May 3rd, HB 1791 was passed by the Senate and sent to Governor Chris Sununu for signature. On June 7th, there was a signing ceremony by Governor Sununu. Read ASBM’s letter urging Governor Sununu to sign HB 1791 here.
Vermont: On May 30th, Governor Phil Scott signed S 92, making Vermont the 42nd state to enact biosimilar substitution legislation.
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| UPCOMING ASBM EVENTS
DIA Annual Conference
Boston, MA – June 24-28
International Pharmaceutical Federation Meeting
Glasgow, Scotland – September 1
Rhode Island Health Systems Pharmacists CE Course
Providence, RI – September 26
Long Island University College of Pharmacy CE Course
Queens, NY – September 30
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