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.
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.
|Oklahoma Becomes Final State to Permit Biosimilar Substitution
On April 22nd, Oklahoma Governor Kevin Stitt signed SB 4, making Oklahoma the 50th and final state to enact a law permitting biosimilar substitution.
SB 4, like similar legislation in other states, permits interchangeable biosimilars to be substituted at the pharmacy level once approved by the FDA. Patients and physicians must be informed of a substitution, and one may be prevented by the physician if deemed medically necessary.
The substitution of medicines is governed at the state level, but state pharmacy acts were written before the advent of biosimilars and did not reflect their differences from generics of small-molecule drugs. Updating these acts nationwide has been a 10-year endeavor involving the collaborative efforts of many patient advocacy organizations, physician and pharmacist societies, manufacturers of originator products and biosimilars, and many other stakeholders.
ASBM has worked since 2011 to educate policymakers nationwide by sharing with them the perspectives of the physicians that prescribe biologics, the pharmacists who dispense them, and the patients who receive them.
ASBM’s efforts in this decade-long campaign consisted of three nationwide physician surveys, the gathering dozens of patient testimonials, physician and pharmacist interviews, innumerable letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding countless educational forums at colleges of medicine and pharmacy.
As ASBM Executive Director Michael Reilly observed:
“This 10-year educational campaign spanned the terms of three ASBM Chairmen and touched every single U.S. state and territory. Today marks the end of a long journey- and a fully-realized victory for patients, as the protections of this legislation now reach nationwide.”
Read about Oklahoma’s SB4 here.
Read about biosimilar substitution laws nationwide here.
|ASBM Presents to World Health Organization at 72nd INN Consultation
On April 13th, ASBM presented to the World Health Organization’s (WHO’s) 72nd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the sixteenth INN Consultation at which ASBM has presented.
ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO.
In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
One argument against distinguishable names was that biosimilars may be seen as inferior and that this would hamper their use. But that has not happened in the USA, and in 5 years of use, two biosimilars of filgrastim have achieved a 72% share of the market; good uptake has also been seen bevacizumab, trastuzumab and pegfilgrastim biosimilars. So, distinguishable names are not an impediment to uptake.
Another argument against the BQ is the presence of existing ways of distinguishing biologics, particularly in pharmacovigilance (PV) programmes. Efforts have been made to improve PV programmes through regulation but in a study of the UK adverse drug reaction (ADR) reporting program, no one reporting system is consistently used. Ideally, all methods of identification should be used but in the UK study, only 38% of reports included an identifiable brand name and only 15% had batch numbers. These findings prompted the authors to conclude that the system needs to be improved. These data are consistent with ASBM’s survey findings that show inconsistent information being included in ADR reports with brand name, batch number and the name of the manufacturer not always being specified.
As biologics and biosimilars continue to increase, with distinguishable non-proprietary names not having a negative impact on the update of biosimilars, and with PV programmes needing to be improved, the lack of a consistent approach points to a need for WHO leadership, just like is happening for the pandemic.
Several early supporters of the BQ have reversed their views, explicitly citing lack of WHO action on naming. Yet they remain willing to harmonise with a global standard should one be made available by the WHO. At the April INN Consultation, the ASBM offered to draft a letter to gauge the level of support for BQ among regulators, and the ASBM repeated this offer
ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.
|ICYMI: ASBM to Present Poster at DIA Global Annual Meeting 2021
From June 27-July 1, 2021, ASBM will virtually present a poster the DIA Global Annual Meeting 2021 entitled “A Review of Problems with Pharmacovigilance Programs and Biologics”. The poster is authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. Dr. Schneider will present the poster in video recording available to conference attendees for the duration of the four-day event.
The poster will examine a variety of published literature on global pharmacovigilance of biologic medicines, with a focus on difficulties in accurately identifying biologics at the product level in Adverse Drug Reaction (ADR) reports and self reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.
Lack of a consistent international standard for biologic naming was identified as a barrier to biosimilar adoption in a recent WHO-sponsored 20-country study. “There is still no consensus among countries on the naming and labeling of biosimilars,” its authors observed, “and the WHO does not provide specific nomenclature for biosimilars.”
In 2014 the WHO’s INN Expert Group proposed a voluntary naming standardto promote accurate biologic identification. But despite early support for the standard from many countries including the US, Canada, Australia, and Japan, it has not yet been made available to national regulatory authorities.
DIA 2021 runs from June 27-July 1, 2021. EPosters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2021.
Learn more about DIA 2021 and see the draft Program Agenda here.
|President Biden Signs Biosimilars Education Bill
On April 23rd, President Biden signed into law S. 164, the “Advancing Education on Biosimilars Act of 2021,” which authorizes the Food and Drug Administration (FDA) to educate consumers and health care providers on biologic products, including biosimilars.
In March, the US Senate unanimously passed the bill, which directs the FDA to improve education on biosimilars with the goal of increasing uptake. Under the law, the FDA will create a biosimilars education website targeted at health care providers. Educational materials offered on the website may include:
Comparative data for originator biologics and biosimilars will also be made available; and, on an ongoing basis, the FDA will maintain continuing education programs to inform health care providers, including nurses, about biosimilars.
Read more about the Advancing Education on Biosimilars Act (S. 164) here.
DIA Global 2021 Annual Meeting
Virtual – June 27- July 1, 2020
WHO 73rd INN Consultation
Geneva, Switzerland – October 19, 2021
World Drug Safety Congress
Boston, Massachusetts – October 20-21, 2021
World Biosimilar Congress Europe 2021
Basel, Switzerland – November 9-11, 2021