October 2019 Newsletter
November 1, 2019
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ASBM Newsletter
Alliance for Safe Biologic Medicines
PO Box 3691 202-870-1480
Arlington, VA 22203
October 2019 Newsletter
November 1, 2019
|
This message was sent to email@example.com from media@safebiologics.org
ASBM Newsletter
Alliance for Safe Biologic Medicines
PO Box 3691 202-870-1480
Arlington, VA 22203
ASBM Presents to WHO, Urging International Harmonization of Biologic Nomenclature
October 28, 2019
On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme, the Executive Summary from the 68th INN Consultation – held on April 2, 2019 and in which ASBM also participated – may be viewed here.
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. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June. 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.
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.
Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?
October 28, 2019
The undisputed leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).
As Canadian provinces including British Columbia and Alberta look to duplicate Europe’s success, ASBM has prepared this fact sheet to serve as a resource.
The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia – and is being considered by other provinces.
B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to Europe’s success:
- It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced-switching mandates.
- Instead, cost reductions were achieved by preserving choice for physicians and patients and promoting competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.
- In nearly every European country, automatic substitution of biologic medicines is not permitted.
- Not only does the B.C. policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.
European physicians have had 13 years of experience with biosimilars, and thus have high familiarity and confidence in them.
- Yet the majority (57%) are opposed to switching their patients to a biosimilar for non-medical (cost) reasons.
- They even more strongly oppose (73%) a third-party initiated non-medical switch of their patients’ biologic medicines, as occurs in the British Columbia policy, and which other provinces are considering.
ASBM’s 2017 survey of Canadian physicians showed similarly strong opposition (64%) to the third-party switching of stable patients for non-medical (e.g. cost) reasons.
Canadian physician groups and patient advocacy organizations have also raised concerns raised with the BC forced-switching policy.
Click here to read the fact sheet.
Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?
October 28, 2019
The undisputed leader in biosimilars with more than 60 products approved and the largest biosimilar market in the world, Europe has achieved impressive biosimilar uptake rates. These can be as high as 91% for older products (before the approval of the first monoclonal antibody biosimilar in 2013) and up to 43% for newer products (approved post-2013).
As Canadian provinces including British Columbia and Alberta look to duplicate Europe’s success, ASBM has prepared this fact sheet to serve as a resource.
The fact sheet contrasts the principles that Europe has embraced- which include preserving physician/patient choice, promoting competition between multiple products, and prohibiting automatic substitution- with the forced-switching policy announced by the government of British Columbia – and is being considered by other provinces.
B.C. Health Minister Adrian Dix cited Europe’s high biosimilar uptake rates as a justification for the [forced-switching] policy, but disregards the path and principles that led to Europe’s success:
- It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced-switching mandates.
- Instead, cost reductions were achieved by preserving choice for physicians and patients and promoting competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.
- In nearly every European country, automatic substitution of biologic medicines is not permitted.
- Not only does the B.C. policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.
European physicians have had 13 years of experience with biosimilars, and thus have high familiarity and confidence in them.
- Yet the majority (57%) are opposed to switching their patients to a biosimilar for non-medical (cost) reasons.
- They even more strongly oppose (73%) a third-party initiated non-medical switch of their patients’ biologic medicines, as occurs in the British Columbia policy, and which other provinces are considering.
ASBM’s 2017 survey of Canadian physicians showed similarly strong opposition (64%) to the third-party switching of stable patients for non-medical (e.g. cost) reasons.
Canadian physician groups and patient advocacy organizations have also raised concerns raised with the BC forced-switching policy.
Click here to read the fact sheet.
ASBM Presents at Biosimilar World Congress: Europe
October 20, 2019
On October 15th and 16th, ASBM participated in the Biosimilar World Congress: Europe 2019, part of the three-day Festival of Biologics held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association.
On the first day, Dr. Schneider participated in two panels. The first was entitled “Increasing Global Patient Access to Biosimilars”. In his presentation, Dr. Schneider emphasized the role that clinicians, including physicians and pharmacists, can play as “learned intermediaries” who can balance patient-specific factors against the objectives of industry and regulators.
Robust pharmacovigilance is also important to increase biosimilar confidence and uptake, said Schneider: “With the reliance on analytics over clinical trials for market approval there is a need for real-world evidence, including strong pharmacovigilance programs. There is general agreement that these programs are not sufficiently strong, including in Europe. This would support the need for a common language with which we communicate clinical experience with biologics and biosimilars – for example, a global system of distinguishable non-proprietary names, as the WHO has proposed.”
Later in the afternoon, Dr. Schneider participated in his second panel, “Biosimilar Market Trends in the USA”. In this panel, Schneider explained the U.S. biosimilar market is complicated by two factors unique to the U.S. The first is the FDA’s standard of “interchangeable” biosimilars- those the FDA has determined will produce the same effects without additional risks after repeated switching with the originator product, relative to patients who remained on the originator product. While no biosimilar has yet been designated “interchangeable”, ASBM has taken a lead in fostering an update in pharmacy practice regulations in nearly every U.S. state to permit pharmacy-based substitution of interchangeable biosimilars in anticipation of FDA action.
The second, and arguably more important factor complicating the U.S. biosimilar market is the rebate system used by Pharmacy Benefit Managers (PBMs). Pushbacks to the PBM model are emerging with employers and individual states in the US based on the perverse incentives resulting from the rebate model, which encourages manufacturers to raise- not lower- prices in order to provide attractive rebates to the PBM and win preferred formulary placement for their product. ASBM has worked with others in the physician and patient advocacy community to highlight the effects of the PBMs’ rebate system, which distort the treatment-decision-making process.
Dr. Schneider also chaired a session on biosimilar sustainability. “There is general agreement that clinician and patient involvement in policy and decision-making is important for uptake of biosimilars, ” Schneider observed. “It is also agreed that there is a need to be mindful of the sustainability of the biologic and biosimilar market for innovation and competition.”
Andrew Spiegel participated in a panel entitled “Stakeholder Collaboration for Biosimilar Sustainability”. In the discussion, Mr. Spiegel emphasized the importance of education to increase physician familiarity and comfort, but also highlighted the importance of not bypassing or excluding the physician from treatment decisions. Spiegel cited the example of British Columbia, whose Health Minister cited Europe’s high uptake rates, yet pushed policies THAT Europe largely rejects, including forced biosimilar substitution, third-party switching of stable patients for non-medical reasons, and elimination of reimbursement of an originator biologic by government fiat.
Mr. Spiegel emphasized that most European countries enjoy high biosimilar rates while preserving physician autonomy: Most European countries do not allow automatic substitution, and reimburse for whichever among multiple products the physician prescribes, including the originator. Only Denmark reimburses ONLY winning product, after a transparent national tender process. Norway also has national tender, but does allow physicians to prescribe- and continues to reimburse- innovator products.
ASBM Presents at Biosimilar World Congress: Europe
October 20, 2019
On October 15th and 16th, ASBM participated in the Biosimilar World Congress: Europe 2019, part of the three-day Festival of Biologics held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association.
On the first day, Dr. Schneider participated in two panels. The first was entitled “Increasing Global Patient Access to Biosimilars”. In his presentation, Dr. Schneider emphasized the role that clinicians, including physicians and pharmacists, can play as “learned intermediaries” who can balance patient-specific factors against the objectives of industry and regulators.
Robust pharmacovigilance is also important to increase biosimilar confidence and uptake, said Schneider: “With the reliance on analytics over clinical trials for market approval there is a need for real-world evidence, including strong pharmacovigilance programs. There is general agreement that these programs are not sufficiently strong, including in Europe. This would support the need for a common language with which we communicate clinical experience with biologics and biosimilars – for example, a global system of distinguishable non-proprietary names, as the WHO has proposed.”
Later in the afternoon, Dr. Schneider participated in his second panel, “Biosimilar Market Trends in the USA”. In this panel, Schneider explained the U.S. biosimilar market is complicated by two factors unique to the U.S. The first is the FDA’s standard of “interchangeable” biosimilars- those the FDA has determined will produce the same effects without additional risks after repeated switching with the originator product, relative to patients who remained on the originator product. While no biosimilar has yet been designated “interchangeable”, ASBM has taken a lead in fostering an update in pharmacy practice regulations in nearly every U.S. state to permit pharmacy-based substitution of interchangeable biosimilars in anticipation of FDA action.
The second, and arguably more important factor complicating the U.S. biosimilar market is the rebate system used by Pharmacy Benefit Managers (PBMs). Pushbacks to the PBM model are emerging with employers and individual states in the US based on the perverse incentives resulting from the rebate model, which encourages manufacturers to raise- not lower- prices in order to provide attractive rebates to the PBM and win preferred formulary placement for their product. ASBM has worked with others in the physician and patient advocacy community to highlight the effects of the PBMs’ rebate system, which distort the treatment-decision-making process.
Dr. Schneider also chaired a session on biosimilar sustainability. “There is general agreement that clinician and patient involvement in policy and decision-making is important for uptake of biosimilars, ” Schneider observed. “It is also agreed that there is a need to be mindful of the sustainability of the biologic and biosimilar market for innovation and competition.”
Andrew Spiegel participated in a panel entitled “Stakeholder Collaboration for Biosimilar Sustainability”. In the discussion, Mr. Spiegel emphasized the importance of education to increase physician familiarity and comfort, but also highlighted the importance of not bypassing or excluding the physician from treatment decisions. Spiegel cited the example of British Columbia, whose Health Minister cited Europe’s high uptake rates, yet pushed policies THAT Europe largely rejects, including forced biosimilar substitution, third-party switching of stable patients for non-medical reasons, and elimination of reimbursement of an originator biologic by government fiat.
Mr. Spiegel emphasized that most European countries enjoy high biosimilar rates while preserving physician autonomy: Most European countries do not allow automatic substitution, and reimburse for whichever among multiple products the physician prescribes, including the originator. Only Denmark reimburses ONLY winning product, after a transparent national tender process. Norway also has national tender, but does allow physicians to prescribe- and continues to reimburse- innovator products.
September 2019 Newsletter
October 1, 2019
|
ASBM Releases Preliminary Findings from European Prescribers Survey at ESMO 2019
October 1, 2019
September 30, 2019 – Barcelona, Spain – The Alliance for Safe Biologic Medicines (ASBM) this week shared preliminary findings from a survey of 575 biologic prescribers in six Western European countries, covering several key policy issues including biosimilar substitution practices, adverse event reporting, and government tendering criteria. Since 2010, the group has routinely surveyed physicians in 13 countries to gather empirical data that can serve as a guide to policymakers on how to increase physician confidence in biosimilars.
The results were presented in a poster and discussion session at the 2019 Congress of the European Society of Medical Oncology (ESMO 2019). Survey respondents were drawn in equal proportion from France, Germany, Italy, Spain, Switzerland, and the United Kingdom. They came from 10 practice areas: Dermatology, Endocrinology, Gastroenterology, Hematology Oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, and Rheumatology. The survey is a follow-up to the group’s 2013 survey of 479 European prescribers.
One policy issue examined in the survey is physician control over biologic treatment decisions, including automatic substitution and non-medical-switching. As governments worldwide seek to control health costs, use of lower cost biosimilars can be an effective tool. Yet unlike generics, biosimilars are not identical copies of the originator product. For this reason, automatic substitution of biologics is rare, and indeed banned in the majority of European Union countries.
“With 13 years of experience prescribing biosimilars, Europe’s physicians have become most knowledgeable and familiar with biosimilars in the world,” said Michael Reilly, executive director of ASBM and poster co-author. While 76% of physicians considered themselves familiar with biosimilars in the 2013 survey, that figure has risen to 90% in 2019.
Mr. Reilly presented the poster at ESMO with fellow co-author Andrew Spiegel, executive director of the Global Colon Cancer Association. “Countries looking to duplicate Europe’s success with biosimilars may look to these results for guidance. Note that the importance of maintaining physician and patient control of treatment decisions – including the decision to switch a stable patient to a biosimilar – has also increased since they were last surveyed six years ago,” said Mr. Reilly.
A strong majority of respondents (82%) considered it “Very Important” or “Critical” to decide which biologic medicine is dispensed to their patients, an increase from 72% in the 2013 survey. In addition, 84% consider the authority to prevent a substitution either “Very Important” or “Critical”, an increase from 74% in the 2013 survey.
While 84% of physicians were comfortable prescribing biosimilars to new patients, the comfort level drops to 60% when switching stable patients to a biosimilar. 58% of physicians were uncomfortable switching patients to a biosimilar for economic rather than health reasons. If the decision to do so were made by a third party, 73% would be uncomfortable.
The ability to choose between several different medicines was also highly important to prescribers: With regard to the awarding of government tenders, a majority of respondents (63%) feel that it is either “Very Important” or “Critical” that tenders to be awarded to multiple suppliers. 83% feel that it is either “Very Important” or “Critical” for national tender offers to consider factors besides price.
“While comfortable with prescribing biosimilars, Europe’s physicians want to have multiple options to choose from, so they can make the best medical decision for their patients – whether that’s the originator product, or one of its biosimilars,” emphasized Mr. Spiegel.
ASBM will be sharing the full results of the survey in a series of meetings with regulators throughout Europe this fall. This will include sharing country-specific data with several national health ministries, as was done with ASBM’s 2013 survey.
Contact: Media@safebiologics.org
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Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative
September 23, 2019
Biosimilars Working Group Responds to Phase II of the BC PharmaCare Biosimilars Initiative
VANCOUVER, BC – Wednesday, September 18, 2019. On September 5, 2019, the BC government announced phase two of its Biosimilars Initiative, informing patients prescribed the originator biologic drug, Remicade® (infliximab), to treat inflammatory bowel disease (Crohn’s disease and ulcerative colitis) that this medication will no longer be covered by the province, and that they must switch to a biosimilar infliximab, either Inflectra® or Renflexis®.1 This means that patients have only six months to meet with their gastroenterologist to discuss switching their medication and to start a replacement product. The sweeping change in coverage is driven by the government’s decision to generate significant healthcare savings from switching patients’ medication rather than negotiating with the makers of the originator biologic to lower their prices.
Biologics are medicines created from living cells and are used to treat a variety of conditions, such as Crohn’s disease, ulcerative colitis, diabetes, rheumatoid arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, and growth deficiencies, to name a few. Biosimilars are highly similar to an originator biologic, but different enough to be sold under their own brand name. Because these drugs are made from living cells, it is impossible to create an identical copy regardless of the use of the exact same manufacturing conditions, ingredients, and process.2 This is a stark comparison to generic drugs, which are made up of chemicals that can be reproduced with the same active ingredient as the original brand name product.3
Health Canada considers a biosimilar to be safe, effective, and of good quality, and highly similar to the originator biologic it references. For a number of reasons, including that the biosimilar companies do not have to invest in discovery and clinical trials, these medicines provide lower-cost options for public payers. However, as the originator biologics are now off-patent, the companies that own these products are willing to negotiate lower prices. Unfortunately, public drug plans prefer to support a biosimilar market.
It is important to note that biosimilars, unlike generic medications, are not interchangeable with the innovator biologic medication. Health Canada set the bar, saying, “Biosimilars are not generic biologics and many characteristics associated with the authorization process and marketed use for generic pharmaceutical drugs do not apply. Authorization of a biosimilar is not a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to the reference biologic drug.” Be wary of anyone who calls biosimilars “biogeneric”, as this is an unacceptable, made-up word for these products.
Health Canada further states that the treating physician, in consultation with the patient, should make the decision to switch a patient after taking into account available clinical evidence.
Canada is the only country in the world to have comprehensive patient support programs paid for by the pharmaceutical companies. This means patients receiving intravenous infusions will need to switch to another group and location to receive their treatment, which could add further stress as they adjust to a new location of care and a new support staff.
The change in coverage is estimated to affect 1,700 patients. This is in addition to about 20,400 British Columbians diagnosed with ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis affected from phase one of the Biosimilars Initiative. This population includes pediatric patients, while pregnant patients may be provided exceptional coverage following approval of request from PharmaCare’s Special Authority branch.4
The Biosimilars Working Group, a diverse cohort of health patient groups dedicated to ensuring the best outcomes for patients, welcomes the BC government’s expansion for access to healthcare services, such as full coverage for the fecal calprotectin test and increased funding for nursing support. However, the cost-driven objective of the forced-switch policy is worrisome as it fails to put physician wisdom, patient choice, appropriateness of care, accessibility, and affordability at the forefront of health policy. Patients should only switch if they decide that this is the best course of action for their conditions, with consultation from their treating physician.
Gail Attara, President & CEO of the Gastrointestinal Society, and member of the Biosimilars Working Group, shared that, “Every disease area is unique and each needs to be treated differently. Patients with limited therapeutic options should not be lumped together with those who have a broader range of options available to them. Many people depend on public coverage and only a select few have private health plans that do better.”5
Surveys conducted on various healthcare stakeholders, including patients, physicians, family caregivers, and the public, in Canada and abroad, reveal synonymous conclusions that treatment decisions should remain between a patient and their physician. Health Canada also encourages patients to speak with their treating physician about switching.6
In 2017, five patient organizations collaborated on a project that surveyed Canadian patients with inflammatory diseases about their perspectives on biologics and biosimilars. Of the 657 individuals surveyed, a vast majority reported being opposed to a forced switch for non-medical reasons.
“We are deeply concerned about the risks associated with a switch. Already, patients with loss of vision depend on accessibility and informed consent when being administered treatments. Furthermore, patients who are stable on a biologic treatment should not be made to potentially jeopardize their safety and quality of life with a mandated switch,” said Louise Gillis, National President of the Canadian Council of the Blind.
Biosimilars in oncology are expected to increase in the Canadian market and the implementations made by the BC government concern many cancer patients. “While we are aware of the value of biosimilars, the Canadian Cancer Survivor Network believes that patients who are being successfully treated by biologics should not be forced to switch. Any such decisions should be made by patients in consultation with their clinicians,” shared Jackie Manthorne, President & CEO of the Canadian Cancer Survivor Network.
The BC Ministry of Health precipitates the need to increase biosimilar uptake due to best practices in the European market, having had over a decade of experience with these products. The Alliance for Safe Biologic Medicines (ASBM), an international and multi-stakeholder organization comprised of healthcare groups, patients, physicians, and biotechnology companies, responded to the BC announcement by releasing a fact sheet analyzing the claims purported by the provincial government.7 “European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient. No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in BC and only very few countries use a procurement process that will reimburse a single product that wins the bid,” said Michael Reilly, Executive Director of ASBM.8
The Biosimilars Working Group will continue to raise the importance of patient choice and evidence-based decision making with policymakers. To stay up-to-date with biosimilars research and policies, please visit www.biosimilaroptions.ca and follow @BiosimilarsWG on Twitter.
About the Biosimilars Working Group:
The Biosimilars Working Group is a key collaboration of diverse non-profit organizations, registered health charities, and healthcare advocacy coalitions who are dedicated to ensuring that good outcomes for patients are at the centre of health policy in Canada, specifically in the biologic medication treatment areas. We create up-to-date and evidence-based educational material for patients and healthcare professionals as a basis to inform our advocacy work on behalf of the patients who we serve.
Working Group Members Participating in This Media Release:
Alliance for Safe Biologic Medicines
Canadian Cancer Survivor Network
Canadian Council of the Blind
Canadian Society of Intestinal Research
Gastrointestinal Society
For more information, please contact Gail Attara, president & chief executive officer of the Gastrointestinal Society, at gail [at] badgut.org, 604-873-4876.
1. Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.
2. Biologics and Biosimilars. GI Society page. Available at: https://badgut.org/information-centre/a-z-digestive-topics/biosimilars-pamphlet/. Accessed 2019-09-11.
3. Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17. Accessed 2019-09-11.
4. Biosimilars Initiative for Patients. Province of British Columbia page. Available at: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients. Accessed 2019-09-11.
5. Gail Attara, “Balancing Act: Cost Containment vs. Patient Health Outcomes,” GI Society Canadian Society of Intestinal Research, available at https://badgut.org/balancing-act/, Accessed 2019-09-11.
6. Biosimilar biologic drugs in Canada: Fact Sheet. Government of Canada page. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a17 Accessed 2019-09-11.
7. ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies. Alliance for Safe Biologic Medicines page. Available at: https://safebiologics.org/wp-content/uploads/2019/08/ASBM-Factsheet-BC-vs-EU-Substitution.pdf. Accessed 2019-09-11.
8. ASBM Raises Concerns for Patients as BC Gov’t Expands Biologics Forced-Switch Policy. Alliance for Safe Biologics page. Available at: https://safebiologics.org/2019/09/asbm-raises-concerns-for-patients-as-bc-govt-expands-biologics-forced-switching-policy/. Accessed 2019-09-12.
