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.
|Controversial Biosimilar Switching Policy in Canada in 2021
As of February, two Canadian provinces, British Columbia and Alberta, have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community.
In a 2017 survey, more than 2/3 of Canadian physicians surveyed said they were not comfortable with a third-party switching their patient to a biosimilar for non-medical reasons (i.e., coverage), as occurs under the BC and Alberta policies. 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.
Full implementation of the Alberta policy was delayed six months as a result of the COVID-19 pandemic. Other provinces including Ontario and Quebec are still considering whether or not to enact similar policies.
Quebec’s National Institute of Excellence in Health and Social Services (INESS) recently released the official English translation of its report “Safety of switching biologics and their interchangeability”. The report found:
There is very little clinician opposition to the use of biosimilars in treatment-naive patients…the picture is different and much more nuanced regarding the use of biosimilars in individuals who are already being treated with a reference biologic drug, in particular because of the risks of immunogenicity posed by the use of biologic drugs and the possible loss of efficacy.
In this respect, all the learned societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor. This position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.
The INESSS report also contrasts BC- and Alberta- style forced-substitution policies with those of Western Europe, likening it more to those in Eastern Europe:
“Most of the jurisdictions examined are in favour of switching patients being treated with a reference biologic drug to a biosimilar, but do not impose this on all patients (via financial penalties or incentives, quotas, etc.)… Only a few European countries (Denmark, Bulgaria, Poland and Serbia) and two Canadian provinces have adopted policies for mandatory non-medical switching for the vast majority of patients (national tendering processes or reimbursement of biosimilars only).”
The pro-competition, pro-physician choice policies found in most European biosimilar markets were the subject of a recent whitepaper by ASBM’s Michael Reilly and Philip Schneider; read that paper here.
Also new for 2021, ASBM Member the Gastrointestinal Society has released a series of resources for Canadian patients, including a handout entitled “Good Biosimilars Policy in Canada 2021” which reflects principles of biosimilar substitution policy supported by GI patient advocacy organizations. From the document:
The Gastrointestinal Society also has a list of recommended exemptions were a province to implement such a policy. These include, pregnant women, the elderly, high-risk patients, those with severe disease, and children.
Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.
|ASBM to Chair Multiple Panels at Festival of Biologics USA 2021
From March 29-April 1st, ASBM will be participating in the Festival of Biologics USA, part of the World Biosimilar Congress USA 2021. The event is typically held in San Diego, CA but will be held virtually this year due to travel restrictions related to the COVID-19 pandemic.
At the event, ASBM Steering Committee Member Andrew Spiegel will moderate two panels. The first will be a keynote panel discussion entitled “Biosimilar Regulatory Reform” on March 29th.
The second will be a plenary keynote panel discussion “Biosimilar Uptake and Progress from the Healthcare Perspective”, on March 31st.
In addition, on March 31st, ASBM Advisory Board Chair Philip Schneider will moderate the closing keynote panel discussion panel: “Harnessing influence to change biosimilar policies: current programs and ideas for the future”
|JAMA Study Examines How Biosimilar Use Varies by Drug Class, Practice Setting
Biosimilar use among Medicare fee-for-service beneficiaries seems to depend most on practice setting and hospital ownership status, with few patient or physician characteristics linked to usage, according to data in JAMA Open Network, reports Healio Rheumatology.
However, the types of practices — outpatient hospital department versus office — and hospital ownership status — for-profit versus not-for-profit — with high biosimilar use appeared to differ vastly based on drug class, noted the researchers.
For example, patients in a hospital outpatient setting were 42% less likely to receive a filgrastim (Neupogen, Amgen) biosimilar than those in an office setting, but 73% more likely to receive an infliximab (Remicade, Janssen) biosimilar.
Read the full article here.
|Standardized Approach for Biosimilar Evaluation and Implementation Aids in Clinical Research: American Healthsystem Pharmacy Journal
The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration, including in clinical research; according to an article appearing in the February issue of the American Journal of Healthsystem Pharmacy.
This article describes the initial approach to evaluating and implementing biosimilar agents at a comprehensive cancer center in Houston, TX, with a focus on strategies, challenges, lessons learned, and ongoing considerations. It also highlights practical considerations and may serve as a guide to other institutions as they navigate the biosimilar landscape and develop their own processes to support the transition to biosimilars in practice.
Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.
Key points of the analysis:
The University of Texas MD Anderson Cancer Center is one of the 50 National Cancer Institute–designated comprehensive cancer centers and was created in 1941 as part of the University of Texas System. In fiscal year 2018, MD Anderson provided care to more than 140,000 patients, including over 10,000 patients enrolled in over 1,250 clinical trials.
Read the full article here.
|National Comprehensive Cancer Network Pharmacy Directors Examine Challenges of Stocking Biosimilars
In February, the National Comprehensive Cancer Network (NCCN) Pharmacy Directors Forum published guidance which addresses challenges of stocking biosimilars, dealing with procurement errors, and obtaining payer authorizations.In the report, the NCCN Pharmacy Directors Forum advises health care providers to lobby for more liberal payer policies, stating that current payer preferences threaten the long-term existence of biosimilars. “We strongly recommend against single-source mandates of biosimilar products by insurance companies for a variety of patient safety and operational reasons,” the NCCN wrote.
(These concerns were echoed by physicians in ASBM’s recent survey of 579 European biologic prescribers, 63% of whom considered it “very important” or “critical” for government tenders for a biosimilar to include multiple suppliers.)
The lower costs that biosimilars offer—approaching 50% in some cases—are enticing. “However, there are several important observations that must be considered which make biosimilar products less than the universal panacea they were hypothesized during their inception,” the NCCN guideline said.
Read the full NCCN Pharmacy Directors report here.
Read a summary of the report here.
|Educational Framework is a Missing Element in Canada’s Biosimilar Discourse: International Foundation on Ageing Report
Since biosimilars first entered the Canadian market in 2009, uptake has been slow in comparison to other OECD countries, with only 18 biosimilars approved to date, and none within ophthalmology, as detailed in a new report from the International Foundation on Ageing (IFA).
Safety, efficacy, and the appropriate use of biosimilars are concerns that impact the lives of patients and their families as well as prescribing physicians. However, there is currently a gap in resources that respond to these concerns internationally and within Canada.
Toward enabling informed decision-making between older Canadians, their caregivers and health care professionals, this report explores the urgent need to build an educational framework. From the report:
Biosimilars in ophthalmology in Canada are on the horizon. Now is the time to strategically plan and act to ensure the education requirements of health care professionals, patients and their families are firmly in place and inform policy development, and not lag behind.
Framed around the goal of enabling informed consultations and decision-making between patients and health care professionals, international biosimilar experiences and to a lesser extent those in Canada provide evidence-based guidance and insight to build an educational framework that serves to inform the debate options on policy and practice.
Read the full report here.
World Biosimilar Congress USA 2021
Virtual – March 29-31, 2021
WHO 72nd INN Consultation
Geneva, Switzerland/Virtual – April 13, 2021
Biologics Europe Online (Webinar)
Virtual – April 26-27, 2021
DIA Global 2020 Annual Meeting
Philadelphia, PA – June 27- July 1, 2020