Quebec Announces Forced Biosimilar Substitution Policy

May 20, 2021

On May 18th, Quebec announced its intention to become the fourth province to require patients to switch to biosimilars. British Columbia and Alberta have already implemented similar policies, and in April, New Brunswick announced it will follow them.

 

Starting April 12, 2022, Quebec will cover, “with exceptions,” only the biosimilar version of drugs. “Despite the inclusion of several biosimilar drugs on the drug lists for many years… they remain underused,” Health Minister Chrisitan Dubé said in a release.

 

The province will require all patients, even those stable on their physician-chosen biologics, to switch to the government-preferred products.

 

Quebec’s National Institute of Excellence in Health and Social Services (INESS) had previously released a 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. 

 

Read more about Quebec’s announcement here. 

FDA Biosimilars Education Bill Signed

May 18, 2021

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:

  • Explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilars
  • Information related to development programs for biological products, including biosimilars and interchangeable biosimilars, and relevant clinical considerations for prescribers
  • An explanation of the process for reporting adverse events for biological products, including biosimilars and interchangeable biosimilars
  • An explanation of the relationship between biosimilars and interchangeable biosimilars licensed under section 351(k) and reference products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product

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.

April 2021 Newsletter

May 18, 2021

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.
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 71st INN Consultation – held on October 20, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

 

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.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 
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:

  • Explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilars
  • Information related to development programs for biological products, including biosimilars and interchangeable biosimilars, and relevant clinical considerations for prescribers
  • An explanation of the process for reporting adverse events for biological products, including biosimilars and interchangeable biosimilars
  • An explanation of the relationship between biosimilars and interchangeable biosimilars licensed under section 351(k) and reference products (as defined in section 351(i)), including the standards for review and licensing of each such type of biological product

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.

 

 

 
UPCOMING EVENTS

 

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

 

Oklahoma Becomes Final State to Permit Biosimilar Substitution 

May 18, 2021

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

May 10, 2021

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.
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 71st INN Consultation – held on October 20, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

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.

Read more about ASBM’s work with the WHO’s INN Group here. 

March 2021 Newsletter

April 1, 2021

ASBM Leads Three Panel Discussions at Festival of Biologics USA 2021

 

From March 29th-31st ASBM representatives led three panel discussions at the World Biosimilar Congress USA 2021, part of the annual Festival of Biologics USA. Typically held in San Diego, CA, the event was conducted virtually this year due the COVID-19 pandemic.

 

On March 29th, ASBM Steering Committee Member Andrew Spiegel moderated a keynote panel discussion entitled “Biosimilar Regulatory Reform”.  Panelists included Eva Temkin, Acting Director for Policy at the U.S. Food and Drug Administration’s Office of Therapeutic Biologics and Biosimilars from 2019-2021 and Leah Christl, former director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND).

 

Panelists shared their thoughts on how clinical biosimilar development may evolve in the future, both in the US and in Europe. Also discussed were challenges in developing orphan biosimilar medicines including what is being done at regulatory level to encourage their development.

 

On March 31st, Spiegel moderated a second panel, entitled “Biosimilar Uptake and Progress from the Healthcare Perspective”. Panelists  included representatives from Hematology/Oncology departments at Boston Medical Center and Highland Hospital, and a representative from the pharmacy contracting company Vizient.

 

The speed of biosimilar uptake was a key topic of the discussion. Recently approved rituximab, trastuzumab, and bevacizumab oncology biosimilars, experienced much faster uptake than earlier biosimilars (filgrastim, peg-filgrastim, erythropoietin alpha and infliximab). Mr. Spiegel asked panelists whether they thought the adalimumab and etanercept biosimilars due in 2023 were likely to experience similarly speedy uptake. The Vizient panelist suggested uptake might be slower.  Gastroenterologists and rheumatologists have been less supportive of biosimilars than oncologists in his view, citing slower uptake among infliximab biosimilars.

 

On March 31st, ASBM Advisory Board Chair Philip Schneider moderated the Closing Keynote Panel that concluded the conference. The topic of the panel was “Harnessing influence  to change biosimilar policies: current programs and ideas for the future.”  Panelists included representatives from the ERISA Industry Committee (ERIC); Boston Medical Center; Ponchartrain Cancer Center; Employers Health; and Biocon.

 

Key points raised during the panel were the importance of transparency in the payment process- particularly among payers and the insurance companies; the role of competition and biosimilars in the marketplace to control the costs of expensive biologics, the need to align incentives among employers and providers, and the need for curricula on biologic in the education of health care professionals.

 

Learn more about the Festival of Biologics USA 2021 and view the full program agenda here. 
 
ASBM to Present Poster at DIA Global Annual Meeting 2021

 

On March 12th, the Program Committee for the DIA Global Annual Meeting 2021 informed ASBM that our poster abstract “A Review of Problems with Pharmacovigilance Programs and Biologics” has been accepted for an ePoster presentation. The abstract was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider.

 

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 idenitifed 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 standard to 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. 

 

 
Study Questions Value of In Vivo Animal Studies for Biosimilars 

 

A new study in the journal Regulatory Toxicology and Clinical Pharmacology suggests in vivo animal studies of biosimilars “have added little evidence to provide clinically relevant information for biosimilar development.” The authors reviewed animal study findings from development of eight biosimilars candidates. Among their findings:

  • In vivo assessments show no unexpected safety or toxicity findings.
  • These animal studies have added little clinically relevant information.
  • The value of conducting in vivo studies for some biosimilars may be questionable.
  • Comparative clinical studies are the best way to confirm clinical similarity.

The study will be published in the print edition of the journal Regulatory Toxicology and Pharmacology Volume 122, June 2021.

 

Read it online here.

 

 
Senate Passes Biosimilar Education Bill

 

On March 3rd, the US Senate unanimously passed the Advancing Education on Biosimilars Act (S 1681). The bill directs the FDA to improve education on biosimilars with the goal of increasing uptake.

 

The bill would require FDA to create a biosimilars education website explaining key statutory and regulatory terms associated with biosimilars, such as “interchangeability”. The website would be targeted at health care providers/
The bill would also require that comparative data for originator biologics and biosimilars is made available; and, on an ongoing basis, continuing education programs would be maintained to inform health care providers, including nurses, about biosimilars.

 

The Senate version of the bill was introduced in May 2019 and was voted on successfully in December 2020, but required a new vote this year. A House version of the bill (HR 4400) was introduced in September 2019 and referred to the Subcommittee on Health.

 

Read more about the Advancing Education on Biosimilars Act (S 1681) here.

 

 
UPCOMING EVENTS

 

Biologics Europe Online 

Virtual – April 26-27, 2021

 

DIA Global 2021 Annual Meeting

Virtual – June 27- July 1, 2020 

 

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

 

ASBM to Chair Multiple Panels at Festival of Biologics USA 2021

March 10, 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” 
Learn more about the Festival of Biologics and view the program agenda here. 

The State of Forced Switching in Canada in 2022

March 10, 2021

Forced Switching: Patient and Physician Concerns
As of July 2022, four Canadian provinces, British Columbia, Alberta, New Brunswick, and Quebec 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.

Read about the biosimilar substitution policies of each Province and Territory here.

In a 2017 survey of Canadian physicians, 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.


Quebec INESSS Report Reiterates Physician Concerns
Notably, Quebec’s policy was implemented over the objections of it physician community. 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.


A Stark Contrast With the Policies of Europe
Proponents of forced switching often cite the high uptake rates and great savings that biosimilars have brought to European countries. Yet in nearly every European country, physicians and patients are free to choose among all approved products- including the originator and several biosimilars- all of which are reimbursed. Among the advanced nations of Western Europe, only Denmark practices forced-switching to a single government-chosen product.

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 entitled “A critical review of substitution policy for biosimilars in Canada”; read that paper here. 


Resources for Canadian Patients
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:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

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. Exemptions to forced-switching policies vary by province. British Columbia’s and Alberta’s policies are the most stringent, with Quebec’s offering more exceptions.

Watch Gastrointestinal Society CEO Gail Attara discuss the Canadian patient experience with forced switching here:

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.

 

The State of Forced Switching in Canada in 2022

March 10, 2021

Forced Switching: Patient and Physician Concerns
As of July 2022, four Canadian provinces, British Columbia, Alberta, New Brunswick, and Quebec 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.

Read about the biosimilar substitution policies of each Province and Territory here.

In a 2017 survey of Canadian physicians, 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.


Quebec INESSS Report Reiterates Physician Concerns
Notably, Quebec’s policy was implemented over the objections of it physician community. 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.


A Stark Contrast With the Policies of Europe
Proponents of forced switching often cite the high uptake rates and great savings that biosimilars have brought to European countries. Yet in nearly every European country, physicians and patients are free to choose among all approved products- including the originator and several biosimilars- all of which are reimbursed. Among the advanced nations of Western Europe, only Denmark practices forced-switching to a single government-chosen product.

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 entitled “A critical review of substitution policy for biosimilars in Canada”; read that paper here. 


Resources for Canadian Patients
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:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

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. Exemptions to forced-switching policies vary by province. British Columbia’s and Alberta’s policies are the most stringent, with Quebec’s offering more exceptions.

Watch Gastrointestinal Society CEO Gail Attara discuss the Canadian patient experience with forced switching here:

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.

 

February 2020

February 28, 2021

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:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

 

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” 
Learn more about the Festival of Biologics and view the program agendahere. 
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.
“For a number of reasons, physicians treating chronic diseases might be less willing to switch patients who are controlled on an originator biologic, such as Remicade, to a biosimilar equivalent,” coauthor Emma Boswell Dean, PhD, of the Miami Business School at the University of Miami, told Healio Rheumatology.

 

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:

  • Collaboration of pharmacy and pharmacy informatics personnel is essential in identifying and implementing optimal ordering tools when transitioning to biosimilar products.
  • Biosimilar adoption may have implications on research protocols, including the consenting process and the need for protocol amendments, requiring institutional review board oversight and, potentially, rolling implementation.
  • Institutions may be required to stock the reference product and biosimilar product(s) during the transition period (or beyond due to conflicting payer policies) and should develop processes to oversee inventory and minimize the risk of errors.

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.
Payers have a large role in the choice of biosimilars, and this was the top-rated concern among those who took the survey. Making the electronic health record work to identify coverage for biosimilars was the second highest-rated concern, followed by the challenges of obtaining payer authorization for biosimilars. Actual procurement of biosimilars and effective storage of multiple biologics also were high-ranking concerns.
“One strategy is to stock multiple biosimilar products…. However, this strategy may increase carrying costs and place a strain on storage requirements such as refrigerators,” the NCCN said. Dispensing errors may increase if staffers grab the wrong product off the shelves.

 

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. 

 

 
UPCOMING EVENTS

 

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 
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