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 Welcomes Ralph McKibbin, MD as Chairman
In a Full Member Call September 9th, ASBM introduced gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF as the organization’s incoming chairman. Dr. McKibbin began his three year term on September 1st, succeeding outgoing chair Madelaine Feldman, MD, FACR. Dr. McKibbin is the fourth chairman since ASBM was founded in 2010.
A practicing gastroenterologist in Altoona, PA, Dr. McKibbin is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC). He has written extensively on the issues of non-medical switching and insurance industry utilization management techniques including step therapy and copay accumulator adjustments. He recently served as the lead author on the DDNC paper “Patient Access To Care And Treatments In The Cost-Shifting Era: Preserving the Patient-Provider Decision-Making Relationship” and authored an op-ed in support of a Pennsylvania bill to restrict non-medical switching and similar practices such as mid-year benefit changes.
Read ASBM’s full announcement about Dr. McKIbbin here.
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| GaBI Journal Publishes Critical Review of Canadian Substitution Policies
On September 30th, the Generics and Biosimilars Initiative published GaBI Journal, Volume 10, 2021, Issue 3, containing a new whitepaper by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider.
The paper is entitled “A Critical Review of Substitution Policy for Biosimilars in Canada” and highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition policies which have proven successful in driving biosimilar uptake in Europe and the U.S. From the paper:
Successful biosimilar markets in the EU and US have demonstrated that forced medical switching is unnecessary to achieve high uptake of biosimilars and the associated savings...This fosters a robust and sustainable biosimilar market with multiple suppliers in any given product class.
Canada desires a robust biosimilar market share like that observed in Europe. While there may be short-term savings from non-medical switching, a long-term consequence of this policy may be decreased competition resulting from fewer products launches and a negative impact on patient safety. Potential drug shortage issues may develop in the absence of multiple suppliers of biologics in each product class. There would also be likely be an undermining the confidence of both physicians and patients in biosimilars that creates an additional barrier to biosimilar uptake.
The successful uptake of biosimilars in Europe was accomplished by limiting the choice of biologic or forced non-medical switching, but through preserving choice for physicians and patients and by promoting competition among all products approved by regulatory authorities. To foster its success in creating a sustainable biosimilars market, Canadian payers can learn from the lessons learned in more mature markets and implement evidence-based transition policies that consider patients’ needs primary.
Read GaBI Journal, Volume 10, 2021, Issue 3 online here.
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| Michael Reilly Op-eds: Forced Biosimilar Switching Puts Canadian Provinces on Wrong Track
During the month of September, two op-eds by ASBM Executive Director Michael Reilly ran in numerous Canadian papers throughout Quebec and New Brunswick. Both provinces recently announced they would be adopting forced biosimilar switching policies. From the op-eds:
A survey of 403 Canadian specialists found that 73% are uncomfortable with a third party initiating a biologic switch for non-medical reasons (typically the cost), as occurs in the British Columbia and Alberta policies. These findings were affirmed by Quebec’s own government (INESSS) in a May 2020 report which concluded that “Non-medical switching in patients being treated with a reference biologic is generally not accepted by learned societies and the consulted clinicians.”
The Canadian Association of Gastroenterology (CAG) released a paper objecting to the B.C. policy; noting that BC Pharmacare’s substitution policy went against the recommendations of 14 gastroenterology societies throughout Canada and Europe. Many patient advocacy organizations also opposed these policies, including the Gastrointestinal Society and Crohn’s and Colitis Canada.
“It was a very long, difficult 2 1/2 year journey to find [the originally-prescribed] drug. All other drugs failed,” said one B.C. arthritis patient who was forced to switch. “I am shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs.”
The New Brunswick and Quebec announcements cited 15 years of experience with biosimilars in Europe to justify forced switching. However, as the op-ed explains:
Automatic substitution of biologics is almost universally prohibited in Europe. In nearly every European country, physicians are free to choose between multiple products, including the originators, and the payer will reimburse them – resulting in both high biosimilar usage and high savings while preserving patient and physician control of treatment decisions.
Read the Quebec op-ed here (French)
Read ASBM’s new whitepaper “A Critical Review of Substitution Policy for Biosimilars in Canada”. This paper highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition policies which have proven successful in driving biosimilar uptake in Europe and the U.S.
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| FDA Approves 30th Biosimilar, First for Macular Degeneration
On September 17th, the FDA approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older.
Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).
“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.
“Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”
Read more about the approval here.
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| ASBM Presents Third Biosimilars Course with LIU-Pharmacy
On September 28th, ASBM Advisory Board Chair Philip Schneider presented an online Continuing Education (CE) course entitled the “The State of the Biosimilars Market in 2021”. The course was presented in conjunction with Long Island University College of Pharmacy and is the third in the series “Biosimilars: What Pharmacists Need to Know”. The series is accredited by the American Council on Pharmaceutical Education (ACPE).
In the presentation, Dr. Schneider discussed the potential economic benefits of biosimilars, and examined different approaches countries around the world have used for driving their uptake. While some countries experimented with forced substitution of government-preferred products, those with the most successful biosimilars markets permitted physicians to retain control over prescribing decisions. These countries achieved savings through the increased competition of many products being freely available and reimbursed by payers.
Dr. Schneider also discussed patient and physician concerns with the non-medical switching of patients who are stable on their current therapies; and how the U.S. interchangeability standard addresses these concerns.
View the latest course here.
View the first course in the series here: “Biosimilars: What Pharmacists Need to Know”.
View the second course in the series here: “Substitution and Non-Medical Switching”
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| Reminder: Gastrointestinal Society Surveys Alberta and BC Patients on Non-Medical Switching
The Canada-based Gastrointestinal Society has designed a brief survey to capture the biosimilar switching experience in Alberta and British Columbia, two Canadian provinces which have enacted forced biosimilar switching policies. In these provinces, the policy was changed to only provide public coverage for the biosimilar and no longer provides any coverage for the originator biologic.
The survey is open to residents of Alberta and British Columbia who were prescribed an originator biologic but were made to switch to a biosimilar based on government policy changes. Patient caregivers are also eligible. The survey covers these disease indications:
Eligible Alberta and British Columbia patients and caregivers are encouraged to complete the survey here.
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| UPCOMING ASBM EVENTS
WHO 73rd INN Consultation Geneva, Switzerland – October 19, 2021
World Drug Safety Congress Americas Boston, Massachusetts – October 20-21, 2021
World Biosimilar Congress Europe 2021 Basel, Switzerland – November 9-11, 2021
World Biosimilar Congress USA 2022 San Diego, California – March 9-11, 2022
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