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September 2019 Newsletter

Who We Are

The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.

Our Perspective

Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.

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.

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info@safebiologics.org
For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
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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.
Read the full fact sheet here. 

 

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

 

 


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The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups — from patients to physicians, medical innovators, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

Contact Us

Who we are
  • About Us
  • Contact Us
  • Member Partners
  • International Advisory Board
News
  • Latest News
  • Letters
  • Newsletter
  • Press Releases
  • Recent Events
The Issue
  • Interchangeable Biosimilars
  • Inflation Reduction Act (IRA)
  • Naming
  • Substitution Policy
  • Biologic Safety
  • BIO Principles
Policy
  • Australia
  • Canada
  • European Union
  • FDA
  • FDA Guidance
  • In the States
Resources
  • Surveys
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