Safe Biologics

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. 

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.

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. 

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. 

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.

Missed last month’s ASBM Newsletter? Read it Here.

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

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. 

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.

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. 

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. 

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.

Missed last month’s ASBM Newsletter? Read it Here.

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