Alex Azar Sworn in as HHS Secretary 

February 2, 2018

On January 29th, Alex Azar was sworn in as Secretary of the Department of Health and Human Services (HHS) by Vice President Mike Pence following remarks by President Trump. ASBM Executive Director Michael Reilly, who served as Mr. Azar’s Deputy from 2005-2007, was in attendance.

 

Mr. Azar previously spent four years as the Department’s general counsel, and two years as Deputy Secretary. After leaving the Department, Mr. Azar spent five years as President of Lilly USA. Mr. Azar was confirmed January 25th by the Senate with a vote of 55-43.

 

For the full vote, see here.


TGA Releases Response to Stakeholder Naming Consultation

January 26, 2018

 

On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World Health Organization, the U.S. FDA, and Health Canada. The TGA received 34 responses, which were divided on the merits of using distinguishing suffixes.

In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The distinct naming approach was also endorsed by Australian physician societies, patient advocacy organizations, and several biologic manufacturers.

Ultimately however, the TGA decided to continue to follow the approach used by the European Medicines Agency (using a biosimilar’s trade name in conjunction with a shared nonproprietary name) and work towards additional enhancements including the implementation of a machine-readable barcode on all biologics.

Read more about the TGA response here. 


TGA Releases Response to Stakeholder Naming Consultation

January 26, 2018

 

On January 24th, the Australian Therapeutic Goods Administration (TGA) released the response to its recent stakeholder consultation on biosimilar naming. The regulator sought input on whether or not it should use distinguishing suffixes for biologics and biosimilars to improve product identification and adverse event reporting. A suffix approach is currently supported by the World Health Organization, the U.S. FDA, and Health Canada. The TGA received 34 responses, which were divided on the merits of using distinguishing suffixes.

In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s Biological Qualifier (BQ) proposal. The distinct naming approach was also endorsed by Australian physician societies, patient advocacy organizations, and several biologic manufacturers.

Ultimately however, the TGA decided to continue to follow the approach used by the European Medicines Agency (using a biosimilar’s trade name in conjunction with a shared nonproprietary name) and work towards additional enhancements including the implementation of a machine-readable barcode on all biologics.

Read more about the TGA response here. 


Biosimilar Innovation Plan Part of FDA’s 2018 Strategic Roadmap

January 12, 2018

On January 11th, the FDA released its 2018 Strategic Policy Roadmap, which outlines its key priorities for 2018, including increasing access to new medicines.

 

We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments and services,” said FDA Commissioner Scott Gottlieb. Regarding biosimilars, the Roadmap emphasizes that FDA will focus on making the process for developing and approving biosimilar drugs more efficient, and promoting cost reductions through increased competition:

 

“As part of these efforts, we will create better incentives for the adoption of safe, effective, and high-quality biosimilar drugs. These policies will be part of a new Biosimilar Innovation Plan (BIP) that we will advance over the coming year.

 

As FDA improves its policies related to new product development, it is imperative that we balance increased access to lower-cost, generic medicines and biosimilars with the benefits of new product innovation. Competition plays a key role in reducing costs of products like prescription drugs, and enabling broader access to beneficial medicines. Greater access to effective drugs also helps advance the public health and lower overall health care costs by improving health outcomes and reducing the cost and burden of disease. Enabling access to safe and effective innovation that can promote better health is a critical part of FDA’s mandate.” 

 

Read the 2018 Strategic Roadmap here. 


CMS Reversal on Shared Billing Codes Will Save $65 Billion

January 5, 2018

On January 4th, the Roanoke Times published an op-ed by Stacie Phan, Executive Director of the Biosimilars Forum, discussing the potential cost savings of biosimilars, especially to the Medicare program:

“…a recent decision by the Centers for Medicare & Medicaid Services to change a billing policy that jeopardized the long-term stability of the biosimilars market could also help pave the way for increased development of biosimilars. The CMS rule change to assign each biosimilar a unique billing code will lead to greater opportunity for increased competition, greater cost savings, and more choices for patients. In fact, the Biosimilars Forum estimates the new rule will reduce Medicare costs by $65 billion over ten years.”

In November, CMS reversed the policy made in 2015 under the Obama Administration, in which all biosimilars sharing one reference product would also share a single billing code. The initial policy had faced broad opposition from manufacturers of biologics and biosimilars, as well as representatives of the physician, pharmacist, and patient communities. ASBM was among these opponents.

On September 11th, 2017, ASBM submitted comments to CMS which reiterated our concerns in detail and urged CMS to reconsider the policy. Learn more about the decision here.

Read the op-ed here. 


ASBM Executive Director’s Op-ed Published in Vancouver Sun

December 25, 2017

On December 25th, the Vancouver Sun published an op-ed authored by ASBM Executive Director, Michael Reilly, regarding the topic of Non-Medical Switching of biosimilars. Non-Medical Switching is when a biosimilar is substituted by a third party in place of the biologic medicine prescribed by the physician, for reasons other than the patient’s health or safety. 

In the op-ed, Mr. Reilly references the findings of ASBM’s recent survey of 403 Canadian prescribers of biologics: 

“Our survey also found that most doctors were not comfortable with a third party switching a patient’s medicine for non-medical reasons. Many worry the different medications may cause adverse effects in patients. I am hoping British Columbia…will play a leadership role in working with Canadian physicians and stakeholders to develop guidelines on the responsible switching of originator biologics and biosimilars.

Biosimilars [offer] patients and physicians lower cost alternatives and different therapeutic options. But for biosimilars to be introduced and used successfully, decision makers must rely on the input and opinions of those who prescribe them.”

 

Read the full op-ed here.


ASBM Executive Director’s Op-ed Published in Vancouver Sun

December 25, 2017

On December 25th, the Vancouver Sun published an op-ed authored by ASBM Executive Director, Michael Reilly, regarding the topic of Non-Medical Switching of biosimilars. Non-Medical Switching is when a biosimilar is substituted by a third party in place of the biologic medicine prescribed by the physician, for reasons other than the patient’s health or safety. 

In the op-ed, Mr. Reilly references the findings of ASBM’s recent survey of 403 Canadian prescribers of biologics: 

“Our survey also found that most doctors were not comfortable with a third party switching a patient’s medicine for non-medical reasons. Many worry the different medications may cause adverse effects in patients. I am hoping British Columbia…will play a leadership role in working with Canadian physicians and stakeholders to develop guidelines on the responsible switching of originator biologics and biosimilars.

Biosimilars [offer] patients and physicians lower cost alternatives and different therapeutic options. But for biosimilars to be introduced and used successfully, decision makers must rely on the input and opinions of those who prescribe them.”

 

Read the full op-ed here.


Behind the Numbers: A Q&A With ASBM’s Michael Reilly

December 7, 2017

 

The Alliance for Safe Biologic Medicines conducts regular surveys to better understand physicians’ perspectives on originator biologics and biosimilars. The organization recently released its 2017 Canadian Prescriber Survey. The survey reveals Canadian physicians’ attitudes on a number of critical policy issues surrounding the approval and use of originator biologics and biosimilars.

 

83 per cent of Canadian doctors considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients, according to the survey of 403 Canadian prescribers of biologics.

 

Canadian doctors also believe that biologics and biosimilars should have distinct names. Of physicians surveyed, 68 percent were in favor of Health Canada granting distinct nonproprietary names for biologics and biosimilars.

 

These results come at a time when policy discussions about these medicines are taking place, and could have clinical implications for years to come.

 

As the name implies, biosimilars are similar but not identical to originator biologics. These important medications treat a variety of complex diseases, like rheumatoid arthritis, Crohn’s disease, diabetes, psoriasis and others.

 

We caught up with Michael Reilly, executive director of ASBM, to discuss the what the results revealed, and what they could mean for Canadian health care professionals and patients.

 

The Alliance for Safe Biologic Medicines (ASBM) recently published data from a study of Canadian physicians. What were the objectives of the survey?

 

Michael Reilly: This is a follow-up to the survey we first conducted in 2014 to gain a better understanding of Canadian physicians’ perspectives around biosimilars. The overall objectives were to capture these positions and share them with stakeholders, regulators and Health Canada.

 

One theme from the study was the topic of non-medical switching and substitution of innovator biologic medicines and biosimilars. What did you learn from the study, and why is this a topic of interest to Canadians?

 

Michael Reilly: Canadian physicians have serious concerns about the possible switching of a patient’s medicine for non-medical reasons, such as cost. They think it is bad policy, and more importantly, problematic for patients to be switched from one medication to another without physician involvement.

 

This is important for Canadians because the provinces are making decisions about whether or not automatic substitution occurs. We think it’s important for the provinces to understand that physicians are overwhelmingly opposed to automatic substitution for non-medical reasons.

 

What is the significance of these findings in the context of the Canadian health care landscape?

Michael Reilly: The findings make it clear that provinces should be cautious before they move to a system of automatic substitution. Canadian doctors have serious concerns about this, and patients ultimately want physicians involved in decision-making.

In fact, Health Canada recommends that a decision to switch a patient being treated with an innovator biologic drug to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence. But ultimately, decisions around automatic substitution are up to the provinces.

What is ASBM’s position on the findings? What does ASBM hope will come out of this research?

Michael Reilly: We advise moving slowly in terms of an automatic substitution policy.

And we hope provincial governments will use this information and reach out to ASBM and others as they consider how to proceed. ASBM’s goal is to see forward-thinking, sustainable biosimilars policies that offer benefits for patients and physicians, balanced with lowering cost and providing access to treatments.

 

Another theme in the research was the naming of originator biologics and biosimilars. What did the data reveal and why is that important?

Michael Reilly: As we’ve seen with numerous surveys in other countries as well as the 2014 survey in Canada, the data revealed overwhelming support for distinguishable naming of biologics and biosimilars by the physician community. Canadian doctors believe that distinguishable, non-proprietary names are important to better ensure clear communication throughout the treatment process, and to improve tracking of safety and efficacy.

 

Why is this significant to Canadians? What does ASBM hope will come out of this research?

 

Michael Reilly: Health Canada and global leaders including the World Health Organization are trying to determine what naming policy should be implemented at the country level and globally. By better understanding the physicians’ perspectives on the need for distinguishable naming and the benefits from a pharmacovigilance standpoint, Health Canada can decide what the policy should look like.

Our position, which is informed by the physician data, is that Health Canada should take a leadership role, working with the WHO and FDA. Collectively, they have the credibility to move toward a unified solution to this global naming problem.

  

 


Behind the Numbers: A Q&A With ASBM’s Michael Reilly

December 7, 2017

 

The Alliance for Safe Biologic Medicines conducts regular surveys to better understand physicians’ perspectives on originator biologics and biosimilars. The organization recently released its 2017 Canadian Prescriber Survey. The survey reveals Canadian physicians’ attitudes on a number of critical policy issues surrounding the approval and use of originator biologics and biosimilars.

 

83 per cent of Canadian doctors considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients, according to the survey of 403 Canadian prescribers of biologics.

 

Canadian doctors also believe that biologics and biosimilars should have distinct names. Of physicians surveyed, 68 percent were in favor of Health Canada granting distinct nonproprietary names for biologics and biosimilars.

 

These results come at a time when policy discussions about these medicines are taking place, and could have clinical implications for years to come.

 

As the name implies, biosimilars are similar but not identical to originator biologics. These important medications treat a variety of complex diseases, like rheumatoid arthritis, Crohn’s disease, diabetes, psoriasis and others.

 

We caught up with Michael Reilly, executive director of ASBM, to discuss the what the results revealed, and what they could mean for Canadian health care professionals and patients.

 

The Alliance for Safe Biologic Medicines (ASBM) recently published data from a study of Canadian physicians. What were the objectives of the survey?

 

Michael Reilly: This is a follow-up to the survey we first conducted in 2014 to gain a better understanding of Canadian physicians’ perspectives around biosimilars. The overall objectives were to capture these positions and share them with stakeholders, regulators and Health Canada.

 

One theme from the study was the topic of non-medical switching and substitution of innovator biologic medicines and biosimilars. What did you learn from the study, and why is this a topic of interest to Canadians?

 

Michael Reilly: Canadian physicians have serious concerns about the possible switching of a patient’s medicine for non-medical reasons, such as cost. They think it is bad policy, and more importantly, problematic for patients to be switched from one medication to another without physician involvement.

 

This is important for Canadians because the provinces are making decisions about whether or not automatic substitution occurs. We think it’s important for the provinces to understand that physicians are overwhelmingly opposed to automatic substitution for non-medical reasons.

 

What is the significance of these findings in the context of the Canadian health care landscape?

Michael Reilly: The findings make it clear that provinces should be cautious before they move to a system of automatic substitution. Canadian doctors have serious concerns about this, and patients ultimately want physicians involved in decision-making.

In fact, Health Canada recommends that a decision to switch a patient being treated with an innovator biologic drug to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence. But ultimately, decisions around automatic substitution are up to the provinces.

What is ASBM’s position on the findings? What does ASBM hope will come out of this research?

Michael Reilly: We advise moving slowly in terms of an automatic substitution policy.

And we hope provincial governments will use this information and reach out to ASBM and others as they consider how to proceed. ASBM’s goal is to see forward-thinking, sustainable biosimilars policies that offer benefits for patients and physicians, balanced with lowering cost and providing access to treatments.

 

Another theme in the research was the naming of originator biologics and biosimilars. What did the data reveal and why is that important?

Michael Reilly: As we’ve seen with numerous surveys in other countries as well as the 2014 survey in Canada, the data revealed overwhelming support for distinguishable naming of biologics and biosimilars by the physician community. Canadian doctors believe that distinguishable, non-proprietary names are important to better ensure clear communication throughout the treatment process, and to improve tracking of safety and efficacy.

 

Why is this significant to Canadians? What does ASBM hope will come out of this research?

 

Michael Reilly: Health Canada and global leaders including the World Health Organization are trying to determine what naming policy should be implemented at the country level and globally. By better understanding the physicians’ perspectives on the need for distinguishable naming and the benefits from a pharmacovigilance standpoint, Health Canada can decide what the policy should look like.

Our position, which is informed by the physician data, is that Health Canada should take a leadership role, working with the WHO and FDA. Collectively, they have the credibility to move toward a unified solution to this global naming problem.

  

 


VIDEO: Canadian Physicians on Non-Medical Switching, Biosimilar Naming

December 7, 2017


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