New White Paper To Detail European Biosimilar Evolution and Policy Principles

November 9, 2019

November 6, 2019 – Gatineau, Quebec – The Alliance for Safe Biologic Medicines (ASBM) today released an abstract from a forthcoming white paper that provides a comprehensive overview of the evolution of the European biosimilars market.  The abstract was released in conjunction with the Drug Information Association (DIA) Annual Canadian Meeting, an annual meeting of Canadian health regulators and pharmaceutical manufacturers, held this year in Gatineau, Quebec. The full whitepaper will be published in the Journal of the Generics and Biosimilars Initiative (GaBI Journal) later this month.

As the world leader in biosimilar approval and commercialization, Europe comprises more than half of the global biosimilar market with more than 60 approved biosimilars. Average biosimilar uptake rates across European countries is 43% for complex biosimilars such as monoclonal antibodies, first approved in 2013. For older biosimilars approved before 2013 the average market share is 91%, according to the whitepaper. From the abstract:

“European countries, with their diverse healthcare systems and their experience to date, serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market, and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.

ASBM Executive Director, Michael Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.

 

Contact: Media@safebiologics.org
###

ASBM Exhibits at DIA Annual Canadian Meeting

November 8, 2019

On November 5th and 6th, ASBM exhibited at the (Drug Information Association (DIA) Annual Canadian Meeting, a meeting of Canadian regulators, researchers, health professionals and pharmaceutical manufacturers.  Held in Gatineau, Quebec, just outside the Canadian capital of Ottawa, the meeting’s purpose is to present a comprehensive overview of the current bio-pharma and device landscape in Canada, while sharing insights into Canada’s broader role in global healthcare product development. Session topics included the patient experience, international collaboration, and the use of real-world evidence in safety and efficacy monitoring.

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, MS FASHP FFIP. At ASBM’s booth, Schneider met with conference attendees, including several Health Canada officials, to discuss ASBM’s work. Policy issues discussed included the importance of distinct biologic nomenclature in pharmacovigilance, efforts toward international harmonization of biologic nomenclature, and emerging biosimilar substitution policies in Canada.

With Canadian provinces beginning to adopt their own biosimilar substitution policies, ASBM also used the Meeting as an opportunity to discuss potential lessons that could be learned from European countries. While at DIA Canada, ASBM released the abstract of a forthcoming whitepaper on the European biosimilars experience, co-authored by Dr. Schneider and ASBM executive director Michael Reilly. The paper examines the policies which led to Europe’s success- including preserving physician choice and promoting competition between multiple products:

“Due to its global leadership in biosimilar regulation and approvals, the biosimilar market in Europe has been the largest market to date, representing approximately 60% of the global biosimilar market and growing consistently year over year. As a result, European countries with their diverse healthcare systems and their experience to date serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

The abstract was available at the ASBM booth, as was a new fact sheet, entitled “What Can Canada Learn From the European Biosimilar Experience?”, which incorporates findings from the whitepaper, data from ASBM’s recent survey of 579 European physicians, and the perspectives of Canadian physicians and patient advocacy organizations on substitution policy.

img_0356
ASBM Advisory Board Chair Philip Schneider (right) discusses biosimilar policy with a Health Canada official.

 

 

 

October 2019 Newsletter

November 1, 2019

newsletter | October 2019
issue 81

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed 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 ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
GaBI Journal Publishes Abstract of ASBM’s Forthcoming Whitepaper on European Biosimilar Market

 

On October 30th, the Journal of the Generics and Biosimilar Initiative (GaBI Journal) published the abstract of ASBM’s forthcoming whitepaper on the evolution of the European biosimilar market. The whitepaper, co-authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, will be published in the next issue of Gabi Journal. From the abstract:

 

“European countries, with their diverse healthcare systems and their experience to date, serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market, and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

 

In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.

 

Mr. Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.

 

Read the abstract of the forthcoming whitepaper here. 

 

 
ASBM Participates in European Commission Biosimilars Meeting

 

On October 30th, ASBM participated in the fifth annual “Stakeholder Event on Biosimilar Medicinal Products” held in Brussels, Belgium.

The day-long multi-stakeholder event was organized by the European Commission and the European Medicines Agency (EMA).

 

Participants included representatives of public authorities, patients’ organizations, healthcare professionals, and pharmaceutical companies. They shared their best practices and clinical experiences with biological medicines, including biosimilars.

 

Topics included the uptake of biosimilars in oncology, sustainable procurement practices, and how to improve the understanding of biosimilars.

 

Read more about the Stakeholder Event here. 

 
ASBM Presents to WHO, Urging Action on International Harmonization of Biologic Naming

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 on this topic 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.

 

Read more about ASBM’s work on international harmonization of global nomenclature here. 

 

 
ASBM Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?

 

On October 28th, ASBM posted a fact sheet entitled “What Can Canada Learn from the European Biosimilar Experience?” to serve as a resource as Canadian provinces, including British Columbia and Alberta, look to duplicate Europe’s success with biosimilars.

 

The undisputed global 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).

 

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:

 

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 this success.

 

It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced switching mandates, but through preserving choice for physicians and patient and promoting ongoing competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.

 

Not only does the B.C policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.

 

The fact sheet also reflects concerns raised with the BC policy by Canadian physicians and patient advocates. In addition, it includes data from ASBM’s 2017 survey of Canadian physicians, showing strong opposition to the third-party switching of stable patients for non-medical (e.g. cost) reasons, as happens under the B.C. policy.

 

View the fact sheet here.

 

 
ASBM Presents at Biosimilar World Congress: Europe 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 a panel entitiled “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 the pharmaceutical industry and of 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.”

 

On day two, 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. These include 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 the winning product, following a transparent national tender process. Norway also has a national tender, but allows physicians to prescribe- and continues to reimburse- innovator products.

 

Read more about ASBM’s participation in the conference here. 

 
UPCOMING EVENTS

 

ASHP Midyear Clinical Meeting 

Las Vegas, NV – December 8-12, 2019
DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

American Society of Clincial Oncology (ASCO) Annual Meeting

Chicago –  May 29 -June 2, 2020

 

EULAR European Congress of Rheumatology 2020

Frankfurt, Germany – June 3-6, 2020

 

 

October 2019 Newsletter

November 1, 2019

newsletter | October 2019
issue 81

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed 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 ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
GaBI Journal Publishes Abstract of ASBM’s Forthcoming Whitepaper on European Biosimilar Market

 

On October 30th, the Journal of the Generics and Biosimilar Initiative (GaBI Journal) published the abstract of ASBM’s forthcoming whitepaper on the evolution of the European biosimilar market. The whitepaper, co-authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider, will be published in the next issue of Gabi Journal. From the abstract:

 

“European countries, with their diverse healthcare systems and their experience to date, serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market, and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

 

In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.

 

Mr. Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.

 

Read the abstract of the forthcoming whitepaper here. 

 

 
ASBM Participates in European Commission Biosimilars Meeting

 

On October 30th, ASBM participated in the fifth annual “Stakeholder Event on Biosimilar Medicinal Products” held in Brussels, Belgium.

The day-long multi-stakeholder event was organized by the European Commission and the European Medicines Agency (EMA).

 

Participants included representatives of public authorities, patients’ organizations, healthcare professionals, and pharmaceutical companies. They shared their best practices and clinical experiences with biological medicines, including biosimilars.

 

Topics included the uptake of biosimilars in oncology, sustainable procurement practices, and how to improve the understanding of biosimilars.

 

Read more about the Stakeholder Event here. 

 
ASBM Presents to WHO, Urging Action on International Harmonization of Biologic Naming

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 on this topic 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.

 

Read more about ASBM’s work on international harmonization of global nomenclature here. 

 

 
ASBM Fact Sheet: What Can Canada Learn from the European Biosimilar Experience?

 

On October 28th, ASBM posted a fact sheet entitled “What Can Canada Learn from the European Biosimilar Experience?” to serve as a resource as Canadian provinces, including British Columbia and Alberta, look to duplicate Europe’s success with biosimilars.

 

The undisputed global 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).

 

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:

 

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 this success.

 

It was not accomplished through a reimbursement ban on originator biologics, i.e., the limitation of medicine choice and resulting forced switching mandates, but through preserving choice for physicians and patient and promoting ongoing competition between all approved products based on many factors including cost, clinical evidence, delivery mechanism, patient history, and other factors.

 

Not only does the B.C policy have no analogue among Western European countries, it is built upon principles Europe has overwhelmingly rejected.

 

The fact sheet also reflects concerns raised with the BC policy by Canadian physicians and patient advocates. In addition, it includes data from ASBM’s 2017 survey of Canadian physicians, showing strong opposition to the third-party switching of stable patients for non-medical (e.g. cost) reasons, as happens under the B.C. policy.

 

View the fact sheet here.

 

 
ASBM Presents at Biosimilar World Congress: Europe 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 a panel entitiled “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 the pharmaceutical industry and of 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.”

 

On day two, 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. These include 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 the winning product, following a transparent national tender process. Norway also has a national tender, but allows physicians to prescribe- and continues to reimburse- innovator products.

 

Read more about ASBM’s participation in the conference here. 

 
UPCOMING EVENTS

 

ASHP Midyear Clinical Meeting 

Las Vegas, NV – December 8-12, 2019
DIA European Meeting 2020

Brussels, Belgium – March 17-19, 2020

 

American Society of Clincial Oncology (ASCO) Annual Meeting

Chicago –  May 29 -June 2, 2020

 

EULAR European Congress of Rheumatology 2020

Frankfurt, Germany – June 3-6, 2020

 

 

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

canadasubstitutionfactsheet
Click to View the Fact Sheet

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

canadasubstitutionfactsheet
Click to View the Fact Sheet

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.

schneider-basel2019-smallRobust 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.

spiegelbasel

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.

schneider-basel2019-smallRobust 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.

spiegelbasel

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

newsletter | September 2019
issue 80
 
 
 

Who We Are
The Alliance for Safe Biologic Medicines is an organization composed 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 ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.

 
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.

For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
Follow Us

Twitter: @SafeBiologics

Facebook

LinkedIn 

YouTube 
ASBM Shares Preliminary EU Physician Survey Results at ESMO 2019

 

On September 29th, ASBM shared preliminary findings from a survey of 579 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, ASBM has routinely surveyed physicians 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), held in Barcelona, Spain. Survey respondents were drawn in equal proportion from France, Germany, Italy, Spain, Switzerland, and the United Kingdom. They practice in one of 10 areas: Dermatology, Endocrinology, Gastroenterology, Hematology Oncology, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, or Rheumatology. The survey is a follow-up to ASBM’s 2013 survey of 479 European prescribers.

 

Key findings presented in the poster and discussion session included:

  • While 76% of physicians considered themselves familiar with biosimilars in the 2013 survey, that figure has risen to 90% in 2019.
  • 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.
“With 13 years of experience prescribing biosimilars, Europe’s physicians have become the most knowledgeable and familiar with biosimilars in the world,” said Michael Reilly, executive director of ASBM and poster co-author.“Countries looking to duplicate Europe’s success with biosimilars may look to these results for guidance.”

Read more about the findings shared at ESMO here. 

 

View the ESMO Poster here. 
 
ASBM Raises Concerns as BC Government Expands Forced-Switching Policy

On September 5th, the Government of British Columbia (B.C.) announced that it would be forcibly switching 1,700 patients with Inflammatory Bowel Disease (IBD) from their current biologic medicine to alternative versions of the treatment, the government’s choice of preferred “biosimilar” products, and cease the reimbursement of their current biologic medicine.

 

The announcement follows a May 27th mandate that 20,700 arthritis, psoriasis, and diabetes patients would be forcibly switched from their existing medicines to the government’s choice of preferred biosimilar products. This forced switching policy was presented as a trade-off for the government’s agreement to grant reimbursement for new innovative medicines, although no new IBD medications have been added to the B.C. public formulary.

 

The policy disregards important scientific considerations for patients on biologic medicines and most alarmingly, eliminates patient choice.

 

“Biosimilar competition and the use of biosimilars can be an effective way to reduce health costs, but potential savings need not, and should not, override patient and physician control of treatment decisions” says ASBM executive director Michael Reilly. “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. Switching from an originator to a biosimilar or between biosimilars remains a clinical decision best made by the treating physician.”

 

Higher uptake rates of biosimilars in Europe have been touted by B.C. Health Minister Adrian Dix as a rationale for the force-switching policy, but it is important to note that Europe has almost universally rejected forced switching as a cost-control mechanism, says Reilly: “No country in Europe has ceased the reimbursement of originator biologics by a government decree such as that issued in B.C. and only very few countries use a procurement process that will reimburse a single product that wins the bid.” ASBM has twice conducted large-scale surveys of European physicians on biosimilar policy issues.

 

Reilly emphasized the sharp contrast between the unique forced-switching policy of B.C. and biosimilar policies in Western Europe, which are built on the principles of education, competition, and physician autonomy:

 

“Nearly all of Western Europe allows physicians to choose between multiple competing products, while encouraging the voluntary prescribing of biosimilars. Only in Denmark and in a few Eastern European countries do we find forced biosimilar switching policies with physician and patient choice eliminated and only one product reimbursed. Canadian patients deserve first-rate health care; this policy moves them in the opposite direction and we respectfully urge the B.C. government to reconsider it.”

Read more about the reactions to the B.C. policy announcement from ASBM and others in the patient advocacy community here. 
 

 

ICYMI: ASBM Releases Fact Sheet: European Biosimilar Policies vs. BC’s Forced-Switch Policy

As the government of British Columbia attempts to increase biosimilar use by force-switching 23,000 patients, Europe enjoys high uptake rates while preserving patient and physician choice.

 

In mid-August, ASBM released a fact sheet contrasting the biosimilar substitution policies of European countries (which generally have robust biosimilar markets) with the newly announced British Columbia policy.
The fact sheet also addresses misconceptions about the market share of biosimilars in Europe. While the rates of biosimilar use for older biosimilars (those approved before 2013) can be as high as 91%, rates for biosimilars approved after 2013 vary from country to country, ranging from 0% to 43%.
In addition, in contrast to the BC policy, the vast majority of European countries leave the decision of what biologic medicine to use with the treating physician in consultation with their patient.
Also, during the 13 years of experience with biosimilar medicines in European markets, no country has directed well-treated patients to either transition to a biosimilar or to change to a different biologic as a condition for the reimbursement of additional innovative drugs and to expand coverage of existing drugs.

 
UPCOMING EVENTS

 

WHO 69th INN Consultation

Geneva, Switzerland – October 22

 

European Commission Biosimilar Stakeholders Meeting

Brussels, Belgium – October 30

 

DIA Annual Canadian Meeting

Gatineau, Quebec – November 5-6
ACR/ARP Annual Meeting

Atlanta, GA – November 8-13

 

 
logo logo logo