Minnesota Budget Passes Without Biosimilar Provisions 

July 12, 2021

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.

 

Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, Inc.), the Global Colon Cancer Association (GCCA), and individual patients in Minnesota communicated to legislators their concerns with the language. In a letter to Minnesota legislators dated April 26, 2021 and co-written with LADA, Inc, ASBM laid out how the provisions might negatively impact prescription costs for patients:

 

The legislation assumes that products with lower wholesale acquisition cost (WAC) or “list” price translates into lower costs for healthcare payers and patients. However, list price is the price before any rebates, discounts, or other price concessions are offered by the drug manufacturer. In practice, manufacturers of biologics must compete on net cost in order to secure a preferred formulary position, but due to negotiated discounts with health plans and PBMs, the net price of a reference product may end up being substantially lower than the net price of a biosimilar with a lower WAC/list price.

 

The availability of biosimilars currently places downward pressure on net prices by forcing reference product manufacturers to discount their products heavily in order to compete. By focusing on the WAC rather than the true (net) cost of the medicine after rebates and discounts, the bill’s language removes the incentive to compete on net prices. We believe that this is counterintuitive to the intent of the legislation and will result in higher rather than lower costs for Minnesota patients.

 

“ASBM, like most patient advocacy organizations, is strongly supportive of legislation written with the goal of realizing cost savings through competition between multiple biologic products” said Executive Director Michael Reilly. “However, the language contained in HF 2128 would have undermined this objective by removing current incentives to compete on price and would have reduced, rather than promoted, affordability of biologics.”

 

Read one of ASBM’s several letters here. 

Read LADA, Inc.’s letter here.

Read GCCA’s letter here. 

Read Minnesota cancer patient Jason Randall’s letter here. 

View the final Minnesota omnibus health and human services bill here.


Minnesota Budget Passes Without Biosimilar Provisions 

July 12, 2021

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.

 

Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, Inc.), the Global Colon Cancer Association (GCCA), and individual patients in Minnesota communicated to legislators their concerns with the language. In a letter to Minnesota legislators dated April 26, 2021 and co-written with LADA, Inc, ASBM laid out how the provisions might negatively impact prescription costs for patients:

 

The legislation assumes that products with lower wholesale acquisition cost (WAC) or “list” price translates into lower costs for healthcare payers and patients. However, list price is the price before any rebates, discounts, or other price concessions are offered by the drug manufacturer. In practice, manufacturers of biologics must compete on net cost in order to secure a preferred formulary position, but due to negotiated discounts with health plans and PBMs, the net price of a reference product may end up being substantially lower than the net price of a biosimilar with a lower WAC/list price.

 

The availability of biosimilars currently places downward pressure on net prices by forcing reference product manufacturers to discount their products heavily in order to compete. By focusing on the WAC rather than the true (net) cost of the medicine after rebates and discounts, the bill’s language removes the incentive to compete on net prices. We believe that this is counterintuitive to the intent of the legislation and will result in higher rather than lower costs for Minnesota patients.

 

“ASBM, like most patient advocacy organizations, is strongly supportive of legislation written with the goal of realizing cost savings through competition between multiple biologic products” said Executive Director Michael Reilly. “However, the language contained in HF 2128 would have undermined this objective by removing current incentives to compete on price and would have reduced, rather than promoted, affordability of biologics.”

 

Read one of ASBM’s several letters here. 

Read LADA, Inc.’s letter here.

Read GCCA’s letter here. 

Read Minnesota cancer patient Jason Randall’s letter here. 

View the final Minnesota omnibus health and human services bill here.


ASBM Reviews Problems with Pharmacovigilance Programs and Biologics at DIA 2021 Global Annual Meeting

July 7, 2021

From June 27-July 1, 2021, ASBM virtually presented 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 presented the poster in a video recording available to conference attendees for the duration of the four-day event.

The poster examines 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 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 ran from June 27-July 1, 2021. EPosters were featured in an online gallery within the virtual meeting platform that is hosting DIA 2021.

View the poster presentation here.

Learn more about DIA 2021 and see the draft Program Agenda here. 

 


ASBM Launches Online Biosimilars Course for Pharmacists

June 12, 2021

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to pharmacists nationwide.
The first entry in the series is entitled “Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects”, and is presented by ASBM Advisory Board Chair, Philip J. Schneider, MS, FASHP.

 

In the presentation, Dr. Schneider provides a basic overview of biologic medicines and biosimilars, covering topics such as:

  • defining biologic medicines and biosimilars
  • development and approval
  • treatment applications (e.g. rheumatoid arthritis, cancer, etc.)
  • Immunogenicity concerns
  • safety, storage and handling considerations
  • differences between biosimilars and generics
  • pharmacovigilance implications
  • interchangeability and pharmacy substitution
  • recent Federal legislation

The course is offered as a 1 hour CE/homestudy for $10.00, but ASBM is offering the course for FREE when you use the code “BioJune1”.

 

The user has to visit pharmce.liu.edu and create an account, and then select the course from the catalog. When checking out, the user enters the code.

 

ASBM and LIU-Pharmacy will be adding additional courses throughout the summer on a wide range of topics including biosimilar substitution practices, non-medical switching, patient and physician perspectives, and biologic pharmacovigilance.

 

View the first entry in the series here. 


ASBM Launches Online Biosimilars Course for Pharmacists

June 12, 2021

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to pharmacists nationwide.
The first entry in the series is entitled “Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects”, and is presented by ASBM Advisory Board Chair, Philip J. Schneider, MS, FASHP.

 

In the presentation, Dr. Schneider provides a basic overview of biologic medicines and biosimilars, covering topics such as:

  • defining biologic medicines and biosimilars
  • development and approval
  • treatment applications (e.g. rheumatoid arthritis, cancer, etc.)
  • Immunogenicity concerns
  • safety, storage and handling considerations
  • differences between biosimilars and generics
  • pharmacovigilance implications
  • interchangeability and pharmacy substitution
  • recent Federal legislation

The course is offered as a 1 hour CE/homestudy for $10.00, but ASBM is offering the course for FREE when you use the code “BioJune1”.

 

The user has to visit pharmce.liu.edu and create an account, and then select the course from the catalog. When checking out, the user enters the code.

 

ASBM and LIU-Pharmacy will be adding additional courses throughout the summer on a wide range of topics including biosimilar substitution practices, non-medical switching, patient and physician perspectives, and biologic pharmacovigilance.

 

View the first entry in the series here. 


May 2021 Newsletter

June 6, 2021

ASBM Launches Online Biosimilars Course for Pharmacists

 

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to pharmacists nationwide.

The first entry in the series is entitled “Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects”, and is presented by ASBM Advisory Board Chair, Philip J. Schneider, MS, FASHP.

 

In the presentation, Dr. Schneider provides a basic overview of biologic medicines and biosimilars, covering topics such as:

  • defining biologic medicines and biosimilars
  • development and approval
  • treatment applications (e.g. rheumatoid arthritis, cancer, etc.)
  • Immunogenicity concerns
  • safety, storage and handling considerations
  • differences between biosimilars and generics
  • pharmacovigilance implications
  • interchangeability and pharmacy substitution
  • recent Federal legislation

The course is offered as a 1 hour CE/homestudy for $10.00, but ASBM is offering the course for FREE when you use the code “BioJune1”.

 

The user has to visit pharmce.liu.edu and create an account, and then select the course from the catalog. When checking out, the user enters the code.

 

ASBM and LIU-Pharmacy will be adding additional courses throughout the summer on a wide range of topics including biosimilar substitution practices, non-medical switching, patient and physician perspectives, and biologic pharmacovigilance.

 

View the first entry in the series here. 

 

 

Interchangeable Biosimilars Anticipated This Summer, Says Expert 

 

The first interchangeable biosimilars- a long-acting insulin biosimilar and a short-acting insulin biosimilar- should be available this summer, according to Sonia T. Oskouei, PharmD, BCMAS, DPLA; in an interview published May 26th in the American Journal of Managed Care at the Center for Biosimilars. Dr. Oskouei is Vice President of Biosimilars at Cardinal Health.
“We are eagerly awaiting this significant milestone in US biosimilar history- to finally experience an interchangeable biosimilar in the market and, additionally, our first true retail biosimilar as well.” observed Dr. Oskouei.

 

“Current guidance by the FDA says these biosimilars have to conduct switching studies, whereby you switch back and forth 3 times to show no differences in outcome, Dr. Oskouei explains. “So, it’s through the submission of that data; that is what is used for the designation.”

 

See the interview with Dr. Oskouei here.

 

 

Quebec Announces Forced Biosimilar Substitution Policy

 

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. 

 

 

Global Colon Cancer Association Seeks Patient and Caregiver Input on Biosimilar Education

 

The Global Colon Cancer Association is conducting a brief survey on biosimilars among the global patient and caregiver community. The goal of this survey is to gather information directly from patients and caregivers so that we can develop educational materials and campaigns that best meet the needs of various communities across the globe.

 

You do not need to be a colorectal cancer patient to take this survey. We are seeking input from individuals who are patients being treated for all disease types as well as caregivers.

 

By completing this survey, you have the option to be entered into a drawing where 2 survey respondents will have a $500 donation made to the charity of their choice, in their name (or a loved one’s name).

 

Your contact information will NOT be shared with anyone outside of the GCCA. You can opt out of communications from GCCA at any time.

 

Note: In this survey, we refer to your country’s regulatory agency. A regulatory agency oversees the approval and monitors the safety of many products including drugs and medical devices. Here are a few examples of the names of the regulatory agencies in various countries:

 

  • Brazil: National Heath Surveillance Agency (ANVISA)
  • Canada: Health Canada’s Health Products and Food Branch (HPFB)
  • India: The Central Drugs Standard Control Organization (CDSCO)Europe: European Medicines Agency (EMA)
  • Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)
  • US: The U.S. Food and Drug Administration’s (FDA)
  • Vietnam: Drug Administration of Vietnam (DAV)

Take the GCCA Biosimilars survey here. 

 

 

Australia Begins Forced Switching of Metastatic Cancer Patients 

 

Bowel Cancer Australia has issued a Patient Alert for Australia’s metastatic cancer patients: beginning on June 1st, 2021, the popular drug Avastin will be withdrawn from Australia’s Pharmaceutical Benefit Scheme (PBS) meaning it will no longer be available to metastatic bowel cancer patients as a subsidized treatment. Avastin is designed to block a protein called vascular endothelial growth factor, or VEGF. Normal cells make VEGF, but some cancer cells make too much VEGF.
The delisting of Avastin coincides with the anticipated listing on the PBS of a biosimilar competitor, removing any real choice for many patients and unfairly penalizing those who are unable to privately fund Avastin.
“The introduction of biosimilars was intended to increase treatment options, but reality suggests the impact will be the opposite” as Bowel Cancer Australia explains on their website:
If metastatic bowel cancer patients remain on Avastin after 1 June, they will have to pay for it. If they cannot afford it, they will be forced to switch to the biosimilar. There is currently no publicly available evidence to support the safety of nonmedical switching in patients with metastatic bowel cancer.

 

Policies that directly impact patients need to consider patient circumstances and preferences.

 

A 2016 ASBM survey of Australian physicians revealed that 90% considered it “very important” or “critical” that physicians and patients retain sole authority to choose which biologic the patient receives.

 

81% believed that “statistically robust comparative clinical trial data that show no increase in risk to safety and efficacy” should be required before a biosimilar could be substituted in place of its reference product.

 

Australian patients have organized an e-petition to Parliament, urging reversal of the decision. The petition reads, in part:

 

This drug is used by thousands of people diagnosed with stage 4 metastatic colorectal cancer and is instrumental to their treatment regime. June is Bowel Cancer Awareness month. Bowel cancer is fast becoming one of this countries biggest killers. Let’s not celebrate the month by taking away people’s medication!

 

View and sign the petition here.

 

Read Bowel Cancer Australia’s Patient Alert here.

 

UPCOMING EVENTS

 

15th Biosimilars Congregation 2021

Virtual – June 23 – June 24, 2021

 

DIA Global 2021 Annual Meeting

Virtual – June 27 – July 1, 2021 

 

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


May 2021 Newsletter

June 6, 2021

ASBM Launches Online Biosimilars Course for Pharmacists

 

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to pharmacists nationwide.

The first entry in the series is entitled “Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects”, and is presented by ASBM Advisory Board Chair, Philip J. Schneider, MS, FASHP.

 

In the presentation, Dr. Schneider provides a basic overview of biologic medicines and biosimilars, covering topics such as:

  • defining biologic medicines and biosimilars
  • development and approval
  • treatment applications (e.g. rheumatoid arthritis, cancer, etc.)
  • Immunogenicity concerns
  • safety, storage and handling considerations
  • differences between biosimilars and generics
  • pharmacovigilance implications
  • interchangeability and pharmacy substitution
  • recent Federal legislation

The course is offered as a 1 hour CE/homestudy for $10.00, but ASBM is offering the course for FREE when you use the code “BioJune1”.

 

The user has to visit pharmce.liu.edu and create an account, and then select the course from the catalog. When checking out, the user enters the code.

 

ASBM and LIU-Pharmacy will be adding additional courses throughout the summer on a wide range of topics including biosimilar substitution practices, non-medical switching, patient and physician perspectives, and biologic pharmacovigilance.

 

View the first entry in the series here. 

 

 

Interchangeable Biosimilars Anticipated This Summer, Says Expert 

 

The first interchangeable biosimilars- a long-acting insulin biosimilar and a short-acting insulin biosimilar- should be available this summer, according to Sonia T. Oskouei, PharmD, BCMAS, DPLA; in an interview published May 26th in the American Journal of Managed Care at the Center for Biosimilars. Dr. Oskouei is Vice President of Biosimilars at Cardinal Health.
“We are eagerly awaiting this significant milestone in US biosimilar history- to finally experience an interchangeable biosimilar in the market and, additionally, our first true retail biosimilar as well.” observed Dr. Oskouei.

 

“Current guidance by the FDA says these biosimilars have to conduct switching studies, whereby you switch back and forth 3 times to show no differences in outcome, Dr. Oskouei explains. “So, it’s through the submission of that data; that is what is used for the designation.”

 

See the interview with Dr. Oskouei here.

 

 

Quebec Announces Forced Biosimilar Substitution Policy

 

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. 

 

 

Global Colon Cancer Association Seeks Patient and Caregiver Input on Biosimilar Education

 

The Global Colon Cancer Association is conducting a brief survey on biosimilars among the global patient and caregiver community. The goal of this survey is to gather information directly from patients and caregivers so that we can develop educational materials and campaigns that best meet the needs of various communities across the globe.

 

You do not need to be a colorectal cancer patient to take this survey. We are seeking input from individuals who are patients being treated for all disease types as well as caregivers.

 

By completing this survey, you have the option to be entered into a drawing where 2 survey respondents will have a $500 donation made to the charity of their choice, in their name (or a loved one’s name).

 

Your contact information will NOT be shared with anyone outside of the GCCA. You can opt out of communications from GCCA at any time.

 

Note: In this survey, we refer to your country’s regulatory agency. A regulatory agency oversees the approval and monitors the safety of many products including drugs and medical devices. Here are a few examples of the names of the regulatory agencies in various countries:

 

  • Brazil: National Heath Surveillance Agency (ANVISA)
  • Canada: Health Canada’s Health Products and Food Branch (HPFB)
  • India: The Central Drugs Standard Control Organization (CDSCO)Europe: European Medicines Agency (EMA)
  • Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)
  • US: The U.S. Food and Drug Administration’s (FDA)
  • Vietnam: Drug Administration of Vietnam (DAV)

Take the GCCA Biosimilars survey here. 

 

 

Australia Begins Forced Switching of Metastatic Cancer Patients 

 

Bowel Cancer Australia has issued a Patient Alert for Australia’s metastatic cancer patients: beginning on June 1st, 2021, the popular drug Avastin will be withdrawn from Australia’s Pharmaceutical Benefit Scheme (PBS) meaning it will no longer be available to metastatic bowel cancer patients as a subsidized treatment. Avastin is designed to block a protein called vascular endothelial growth factor, or VEGF. Normal cells make VEGF, but some cancer cells make too much VEGF.
The delisting of Avastin coincides with the anticipated listing on the PBS of a biosimilar competitor, removing any real choice for many patients and unfairly penalizing those who are unable to privately fund Avastin.
“The introduction of biosimilars was intended to increase treatment options, but reality suggests the impact will be the opposite” as Bowel Cancer Australia explains on their website:
If metastatic bowel cancer patients remain on Avastin after 1 June, they will have to pay for it. If they cannot afford it, they will be forced to switch to the biosimilar. There is currently no publicly available evidence to support the safety of nonmedical switching in patients with metastatic bowel cancer.

 

Policies that directly impact patients need to consider patient circumstances and preferences.

 

A 2016 ASBM survey of Australian physicians revealed that 90% considered it “very important” or “critical” that physicians and patients retain sole authority to choose which biologic the patient receives.

 

81% believed that “statistically robust comparative clinical trial data that show no increase in risk to safety and efficacy” should be required before a biosimilar could be substituted in place of its reference product.

 

Australian patients have organized an e-petition to Parliament, urging reversal of the decision. The petition reads, in part:

 

This drug is used by thousands of people diagnosed with stage 4 metastatic colorectal cancer and is instrumental to their treatment regime. June is Bowel Cancer Awareness month. Bowel cancer is fast becoming one of this countries biggest killers. Let’s not celebrate the month by taking away people’s medication!

 

View and sign the petition here.

 

Read Bowel Cancer Australia’s Patient Alert here.

 

UPCOMING EVENTS

 

15th Biosimilars Congregation 2021

Virtual – June 23 – June 24, 2021

 

DIA Global 2021 Annual Meeting

Virtual – June 27 – July 1, 2021 

 

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


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. 


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.


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