The State of Forced Switching in Canada in 2022

March 10, 2021

Forced Switching: Patient and Physician Concerns
As of July 2022, four Canadian provinces, British Columbia, Alberta, New Brunswick, and Quebec have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community.

Read about the biosimilar substitution policies of each Province and Territory here.

In a 2017 survey of Canadian physicians, more than 2/3 of Canadian physicians surveyed said they were not comfortable with a third-party switching their patient to a biosimilar for non-medical reasons (i.e., coverage), as occurs under the BC and Alberta policies. 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.


Quebec INESSS Report Reiterates Physician Concerns
Notably, Quebec’s policy was implemented over the objections of it physician community. Quebec’s National Institute of Excellence in Health and Social Services (INESS) recently released the official English translation of its 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.


A Stark Contrast With the Policies of Europe
Proponents of forced switching often cite the high uptake rates and great savings that biosimilars have brought to European countries. Yet in nearly every European country, physicians and patients are free to choose among all approved products- including the originator and several biosimilars- all of which are reimbursed. Among the advanced nations of Western Europe, only Denmark practices forced-switching to a single government-chosen product.

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 entitled “A critical review of substitution policy for biosimilars in Canada”; read that paper here. 


Resources for Canadian Patients
ASBM Member the Gastrointestinal Society has released a series of resources for Canadian patients, including a handout entitled “Good Biosimilars Policy in Canada 2021” which reflects principles of biosimilar substitution policy supported by GI patient advocacy organizations. From the document:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

The Gastrointestinal Society also has a list of recommended exemptions  were a province to implement such a policy. These include, pregnant women, the elderly, high-risk patients, those with severe disease, and children. Exemptions to forced-switching policies vary by province. British Columbia’s and Alberta’s policies are the most stringent, with Quebec’s offering more exceptions.

Watch Gastrointestinal Society CEO Gail Attara discuss the Canadian patient experience with forced switching here:

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.

 

The State of Forced Switching in Canada in 2022

March 10, 2021

Forced Switching: Patient and Physician Concerns
As of July 2022, four Canadian provinces, British Columbia, Alberta, New Brunswick, and Quebec have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community.

Read about the biosimilar substitution policies of each Province and Territory here.

In a 2017 survey of Canadian physicians, more than 2/3 of Canadian physicians surveyed said they were not comfortable with a third-party switching their patient to a biosimilar for non-medical reasons (i.e., coverage), as occurs under the BC and Alberta policies. 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.


Quebec INESSS Report Reiterates Physician Concerns
Notably, Quebec’s policy was implemented over the objections of it physician community. Quebec’s National Institute of Excellence in Health and Social Services (INESS) recently released the official English translation of its 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.


A Stark Contrast With the Policies of Europe
Proponents of forced switching often cite the high uptake rates and great savings that biosimilars have brought to European countries. Yet in nearly every European country, physicians and patients are free to choose among all approved products- including the originator and several biosimilars- all of which are reimbursed. Among the advanced nations of Western Europe, only Denmark practices forced-switching to a single government-chosen product.

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 entitled “A critical review of substitution policy for biosimilars in Canada”; read that paper here. 


Resources for Canadian Patients
ASBM Member the Gastrointestinal Society has released a series of resources for Canadian patients, including a handout entitled “Good Biosimilars Policy in Canada 2021” which reflects principles of biosimilar substitution policy supported by GI patient advocacy organizations. From the document:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

The Gastrointestinal Society also has a list of recommended exemptions  were a province to implement such a policy. These include, pregnant women, the elderly, high-risk patients, those with severe disease, and children. Exemptions to forced-switching policies vary by province. British Columbia’s and Alberta’s policies are the most stringent, with Quebec’s offering more exceptions.

Watch Gastrointestinal Society CEO Gail Attara discuss the Canadian patient experience with forced switching here:

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.

 

February 2020

February 28, 2021

Controversial Biosimilar Switching Policy in Canada in 2021 

 

As of February, two Canadian provinces, British Columbia and Alberta, have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community.

 

In a 2017 survey, more than 2/3 of Canadian physicians surveyed said they were not comfortable with a third-party switching their patient to a biosimilar for non-medical reasons (i.e., coverage), as occurs under the BC and Alberta policies. 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.

 

Full implementation of the Alberta policy was delayed six months as a result of the COVID-19 pandemic. Other provinces including Ontario and Quebec are still considering whether or not to enact similar policies.

 

Quebec’s National Institute of Excellence in Health and Social Services (INESS) recently released the official English translation of its 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. 

 

Also new for 2021, ASBM Member the Gastrointestinal Society has released a series of resources for Canadian patients, including a handout entitled “Good Biosimilars Policy in Canada 2021” which reflects principles of biosimilar substitution policy supported by GI patient advocacy organizations. From the document:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

 

The Gastrointestinal Society also has a list of recommended exemptions  were a province to implement such a policy. These include, pregnant women, the elderly, high-risk patients, those with severe disease, and children.

 

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.

 

 
ASBM to Chair Multiple Panels at Festival of Biologics USA 2021

 

From March 29-April 1st, ASBM will be participating in the Festival of Biologics USA, part of the World Biosimilar Congress USA 2021. The event is typically held in San Diego, CA but will be held virtually this year due to travel restrictions related to the COVID-19 pandemic.

 

At the event, ASBM Steering Committee Member Andrew Spiegel will moderate two panels. The first will be a keynote panel discussion entitled “Biosimilar Regulatory Reform” on March 29th.

 

The second will be a plenary keynote panel discussion “Biosimilar Uptake and Progress from the Healthcare Perspective”, on March 31st.

 

In addition, on March 31st, ASBM Advisory Board Chair Philip Schneider will moderate the closing keynote panel discussion panel: “Harnessing influence to change biosimilar policies: current programs and ideas for the future” 
Learn more about the Festival of Biologics and view the program agendahere. 
JAMA Study Examines How Biosimilar Use Varies by Drug Class, Practice Setting

 

Biosimilar use among Medicare fee-for-service beneficiaries seems to depend most on practice setting and hospital ownership status, with few patient or physician characteristics linked to usage, according to data in JAMA Open Network, reports Healio Rheumatology.

 

However, the types of practices — outpatient hospital department versus office — and hospital ownership status — for-profit versus not-for-profit — with high biosimilar use appeared to differ vastly based on drug class, noted the researchers.

 

For example, patients in a hospital outpatient setting were 42% less likely to receive a filgrastim (Neupogen, Amgen) biosimilar than those in an office setting, but 73% more likely to receive an infliximab (Remicade, Janssen) biosimilar.
“For a number of reasons, physicians treating chronic diseases might be less willing to switch patients who are controlled on an originator biologic, such as Remicade, to a biosimilar equivalent,” coauthor Emma Boswell Dean, PhD, of the Miami Business School at the University of Miami, told Healio Rheumatology.

 

Read the full article here. 

 

 
Standardized Approach for Biosimilar Evaluation and Implementation Aids in Clinical Research: American Healthsystem Pharmacy Journal

 

The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration, including in clinical research; according to an article appearing in the February issue of the American Journal of Healthsystem Pharmacy.

 

This article describes the initial approach to evaluating and implementing biosimilar agents at a comprehensive cancer center in Houston, TX, with a focus on strategies, challenges, lessons learned, and ongoing considerations. It also highlights practical considerations and may serve as a guide to other institutions as they navigate the biosimilar landscape and develop their own processes to support the transition to biosimilars in practice.

 

Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.

 

Key points of the analysis:

  • Collaboration of pharmacy and pharmacy informatics personnel is essential in identifying and implementing optimal ordering tools when transitioning to biosimilar products.
  • Biosimilar adoption may have implications on research protocols, including the consenting process and the need for protocol amendments, requiring institutional review board oversight and, potentially, rolling implementation.
  • Institutions may be required to stock the reference product and biosimilar product(s) during the transition period (or beyond due to conflicting payer policies) and should develop processes to oversee inventory and minimize the risk of errors.

The University of Texas MD Anderson Cancer Center is one of the 50 National Cancer Institute–designated comprehensive cancer centers and was created in 1941 as part of the University of Texas System. In fiscal year 2018, MD Anderson provided care to more than 140,000 patients, including over 10,000 patients enrolled in over 1,250 clinical trials.

 

Read the full article here. 

 

 
National Comprehensive Cancer Network Pharmacy Directors Examine Challenges of Stocking Biosimilars
In February, the National Comprehensive Cancer Network (NCCN) Pharmacy Directors Forum published guidance which addresses challenges of stocking biosimilars, dealing with procurement errors, and obtaining payer authorizations.In the report, the NCCN Pharmacy Directors Forum advises health care providers to lobby for more liberal payer policies, stating that current payer preferences threaten the long-term existence of biosimilars. “We strongly recommend against single-source mandates of biosimilar products by insurance companies for a variety of patient safety and operational reasons,” the NCCN wrote.

 

(These concerns were echoed by physicians in ASBM’s recent survey of 579 European biologic prescribers, 63% of whom considered it “very important” or “critical” for government tenders for a biosimilar to include multiple suppliers.)

 

The lower costs that biosimilars offer—approaching 50% in some cases—are enticing. “However, there are several important observations that must be considered which make biosimilar products less than the universal panacea they were hypothesized during their inception,” the NCCN guideline said.
Payers have a large role in the choice of biosimilars, and this was the top-rated concern among those who took the survey. Making the electronic health record work to identify coverage for biosimilars was the second highest-rated concern, followed by the challenges of obtaining payer authorization for biosimilars. Actual procurement of biosimilars and effective storage of multiple biologics also were high-ranking concerns.
“One strategy is to stock multiple biosimilar products…. However, this strategy may increase carrying costs and place a strain on storage requirements such as refrigerators,” the NCCN said. Dispensing errors may increase if staffers grab the wrong product off the shelves.

 

Read the full NCCN Pharmacy Directors report here.

Read a summary of the report here.

 

 
Educational Framework is a Missing Element in Canada’s Biosimilar Discourse: International Foundation on Ageing Report

 

Since biosimilars first entered the Canadian market in 2009, uptake has been slow in comparison to other OECD countries, with only 18 biosimilars approved to date, and none within ophthalmology, as detailed in a new report from the International Foundation on Ageing (IFA).

 

Safety, efficacy, and the appropriate use of biosimilars are concerns that impact the lives of patients and their families as well as prescribing physicians. However, there is currently a gap in resources that respond to these concerns internationally and within Canada.

 

Toward enabling informed decision-making between older Canadians, their caregivers and health care professionals, this report explores the urgent need to build an educational framework. From the report:

 

Biosimilars in ophthalmology in Canada are on the horizon. Now is the time to strategically plan and act to ensure the education requirements of health care professionals, patients and their families are firmly in place and inform policy development, and not lag behind.

 

Framed around the goal of enabling informed consultations and decision-making between patients and health care professionals, international biosimilar experiences and to a lesser extent those in Canada provide evidence-based guidance and insight to build an educational framework that serves to inform the debate options on policy and practice.

 

Read the full report here. 

 

 
UPCOMING EVENTS

 

World Biosimilar Congress USA 2021

Virtual – March 29-31, 2021

 

WHO 72nd INN Consultation

Geneva, Switzerland/Virtual – April 13, 2021

 

Biologics Europe Online (Webinar)

Virtual – April 26-27, 2021

 

DIA Global 2020 Annual Meeting

Philadelphia, PA – June 27- July 1, 2020 

January 2020

February 15, 2021

ASBM’s Andrew Spiegel Interviewed on Susan G. Komen Podcast
On January 28, the Susan G. Komen Foundation released an episode of their podcast “Real Pink” entitled  “The Evolution of Biosimilars as a Cancer Treatment” featuring Andrew Spiegel. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a founding member of ASBM. 

 

In the podcast, Spiegel explains how biologic medicines have extended the life expectancy of cancer patients, and how biosimilars can bring these patients new treatment options at reduced cost.

 

He also details concerns among the physician and patient community surrounding “non-medical switching“- forced switching by third parties such as insurance companies, for financial reasons rather than the health of the patient.
Download/Listen to the podcast here. 

 

Learn more about non-medical switching here. 

 
AHA Adds its Opposition to MFN Rule with Letter to CMS

 

On January 25th, the American Hospital Association (AHA) joined the ever-growing ranks of those opposing the Most Favored Nation (MFN) model interim final rule. The rule should be withdrawn immediately, the American Hospital Association (AHA) said in a letter to CMS.
The MFN model reduces Medicare Part B payments for certain drugs and biologicals to no more than the lowest price the drug manufacturers receive in countries with a similar level of economic development. The AHA contends that the rule is not a serious attempt at drug pricing reform because it does not directly address the cost of drugs. Instead, the rule places financial burden on provider organizations and forces them to divert resources to purchase drugs necessary for patient care, the AHA said.

Opposition to the MFN rule has been broad and come from many quarters, including physicians, patient advocacy organizations, the pharmaceutical industry, hospital associations, and others.

Read more about the AHA letter here.
ASBM Submits Comments on FDA Draft Guidance on Biosimilarity and Interchangeability

 

On January 19th, ASBM submitted comments on Draft Guidance issued November 19, 2020 by the FDA entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars.

 

These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.

ASBM’s comments reiterated support for the FDA interchangeability standard, and for transparent labeling that facilitates informed treatment decision-making by healthcare providers and patients:

 

It is ASBM’s view that biosimilars and interchangeable biosimilars are two separate classes of medicines. The statutory requirements to achieve the designation of interchangeability are appropriately designed to necessitate a higher burden of proof, with a greater focus on the individual patient.

 

To meet these standards, ASBM believes a robust clinical program is required, such that it can be demonstrated, with near certainty, that the biosimilar product will produce the same clinical result as the reference product in any given patient, AND in the case of a biological product administered more than once to a patient, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of using the reference product without such alteration or switch.

 

Regarding Q.I.27 (Labeling of interchangeable biosimilars), ASBM believes that transparent labeling for biosimilar and interchangeable biosimilar products is critical for building physicians’ confidence in the safety of these medicines. Inclusion of approval and safety information generated by the biosimilar sponsor and transparency concerning studied versus extrapolated indications would provide a more comprehensive label to inform physician and pharmacist decisions regarding their patients.

 

Once finalized, FDA will move the questions and answers from the draft guidance to its companion Final Questions and Answers Guidance on biosimilar development.
Read the Draft Guidance here.
 
 

ICYMI: US Biosimilar Market on Pace with Europe
In January, the ASBM-authored whitepaper “US Biosimilars Market on Pace with Europe” was published in the print edition of GaBI Journal 2020 Issue 4. The paper is co-authored by ASBM’s Chair Madelaine Feldman and Executive Director Michael Reilly.

 

The paper demonstrates FDA is moving at approximately the same pace as EMA based on the number of approvals at the same time after implementation of its regulatory pathway:

  • As of September 2020, approximately 10 years after implementation of the biosimilar approval pathway, 28 biosimilars have been approved by FDA, with 18 of those approvals granted in the last 2 years. (Note: this figure has since risen to 29 approvals with the  December 17 approval of Rianbi (rituximab-arrx), which launched January 2021). 
  • For comparison, in the 10-year time period following the creation of Europe’s biosimilar regulatory pathway, EMA approved just 13 biosimilar products (some of which were marketed under several different brand names)
  • Currently, there are 46 biosimilars approved in Europe; however, this fall to 35 when products approved in the US as follow on biologicals via the 505(b)(2) pathway, e.g. somatropin, insulin, teriparatide, or abbreviated new drug application (ANDA) are excluded. Furthermore, Europe’s filgrastim biosimilar Tevagrastim®/Ratiograstim® was approved as Granix® (tbo-filgrastim) in the US via a Biologic License Application (BLA) prior to the implementation of a biosimilars approval pathway and is not included in the US biosimilar count.

In addition, US biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years:

  • As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share.
  • Bevacizumab and trastuzumab biosimilars, launched in 2019-2020 have approximately 40% share.
  • Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

Read the full whitepaper here. 

 

 
UPCOMING EVENTS

 

DIA Latin America Regulatory Conference

Virtual – February 22-23, 2021

 

World Biosimilar Congress USA 2021

Virtual – March 29-31, 2021

 

WHO 72nd INN Consultation

Geneva, Switzerland/Virtual – April 13, 2021

 

Biologics Europe Online (Webinar)

Virtual – April 26-27, 2021

 

 

ASBM’s Andrew Spiegel Interviewed on Susan G. Komen Podcast

January 29, 2021

spiegel-realpink

On January 28, the Susan G. Komen Foundation released an episode of their podcast “Real Pink” entitled  “The Evolution of Biosimilars as a Cancer Treatment” featuring Andrew Spiegel. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a founding member of ASBM. 

In the podcast, Spiegel explains how biologic medicines have extended the life expectancy of cancer patients, and how biosimilars can bring these patients new treatment options at reduced cost.

He also details concerns among the physician and patient community surrounding “non-medical switching“- forced switching by third parties such as insurance companies, for financial reasons rather than the health of the patient.
Download/Listen to the podcast here. 

Learn more about non-medical switching here. 

 

ASBM Submits Comments on FDA Draft Guidance on Biosimilarity and Interchangeability

January 19, 2021

On January 19th, ASBM submitted comments on Draft Guidance issued November 19, 2020 by the FDA entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”

The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars.

These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.

ASBM’s comments reiterated support for the FDA interchangeability standard, and for transparent labeling that facilitates informed treatment decision-making by healthcare providers and patients:

It is ASBM’s view that biosimilars and interchangeable biosimilars are two separate classes of medicines. The statutory requirements to achieve the designation of interchangeability are appropriately designed to necessitate a higher burden of proof, with a greater focus on the individual patient.

To meet these standards, ASBM believes a robust clinical program is required, such that it can be demonstrated, with near certainty, that the biosimilar product will produce the same clinical result as the reference product in any given patient, AND in the case of a biological product administered more than once to a patient, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of using the reference product without such alteration or switch.

Regarding Q.I.27 (Labeling of interchangeable biosimilars), ASBM believes that transparent labeling for biosimilar and interchangeable biosimilar products is critical for building physicians’ confidence in the safety of these medicines. Inclusion of approval and safety information generated by the biosimilar sponsor and transparency concerning studied versus extrapolated indications would provide a more comprehensive label to inform physician and pharmacist decisions regarding their patients.

Once finalized, FDA will move the questions and answers from the draft guidance to its companion Final Questions and Answers Guidance on biosimilar development.
Read the Draft Guidance here. 

ASBM Submits Comments on FDA Draft Guidance on Biosimilarity and Interchangeability

January 19, 2021

On January 19th, ASBM submitted comments on Draft Guidance issued November 19, 2020 by the FDA entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”

The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars.

These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.

ASBM’s comments reiterated support for the FDA interchangeability standard, and for transparent labeling that facilitates informed treatment decision-making by healthcare providers and patients:

It is ASBM’s view that biosimilars and interchangeable biosimilars are two separate classes of medicines. The statutory requirements to achieve the designation of interchangeability are appropriately designed to necessitate a higher burden of proof, with a greater focus on the individual patient.

To meet these standards, ASBM believes a robust clinical program is required, such that it can be demonstrated, with near certainty, that the biosimilar product will produce the same clinical result as the reference product in any given patient, AND in the case of a biological product administered more than once to a patient, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of using the reference product without such alteration or switch.

Regarding Q.I.27 (Labeling of interchangeable biosimilars), ASBM believes that transparent labeling for biosimilar and interchangeable biosimilar products is critical for building physicians’ confidence in the safety of these medicines. Inclusion of approval and safety information generated by the biosimilar sponsor and transparency concerning studied versus extrapolated indications would provide a more comprehensive label to inform physician and pharmacist decisions regarding their patients.

Once finalized, FDA will move the questions and answers from the draft guidance to its companion Final Questions and Answers Guidance on biosimilar development.
Read the Draft Guidance here. 

ASBM Paper is GaBI Journal’s Most-Read Biosimilars Article of 2020

January 6, 2021

According to the editors of the Journal of the Generics and Biosimilar Initiative (GaBI Journal), the most-viewed biosimilars article of 2020 was the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, co-authored by ASBM’s Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The article was published online in February 2020 and in Issue 2 of GaBI Journal’s print edition.

The paper examined biosimilar substitution policies across Europe, looking for commonalities among them which led to successful and sustainable biosimilar markets. The paper found that across Europe, biosimilars have:

  • Increased competition
  • Reduced unit cost of both originator and biosimilars compared to price levels prior to the arrival of biosimilars
  • Increased volume consumption of molecules with biosimilar competition thus expanding market access and optimizing patient dosing
  • Alleviated budget pressures by providing headroom to fund novel treatment solutions

While the policies by which this has been achieved vary somewhat between countries, the paper reveals that all major European markets share the following features:

  • Automatic substitution for biologicals is forbidden
  • All approved biologicals, i.e. originators and their biosimilars, are available on the market and are reimbursed when prescribed
  • Reimbursement decisions on novel treatment solutions are independent from biosimilar use and uptake
  • The time from market approval to first product sales for biosimilars is shorter than the time to first sales of novel medicines

Read the whitepaper here. 

ASBM Paper is GaBI Journal’s Most-Read Biosimilars Article of 2020

January 6, 2021

According to the editors of the Journal of the Generics and Biosimilar Initiative (GaBI Journal), the most-viewed biosimilars article of 2020 was the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, co-authored by ASBM’s Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The article was published online in February 2020 and in Issue 2 of GaBI Journal’s print edition.

The paper examined biosimilar substitution policies across Europe, looking for commonalities among them which led to successful and sustainable biosimilar markets. The paper found that across Europe, biosimilars have:

  • Increased competition
  • Reduced unit cost of both originator and biosimilars compared to price levels prior to the arrival of biosimilars
  • Increased volume consumption of molecules with biosimilar competition thus expanding market access and optimizing patient dosing
  • Alleviated budget pressures by providing headroom to fund novel treatment solutions

While the policies by which this has been achieved vary somewhat between countries, the paper reveals that all major European markets share the following features:

  • Automatic substitution for biologicals is forbidden
  • All approved biologicals, i.e. originators and their biosimilars, are available on the market and are reimbursed when prescribed
  • Reimbursement decisions on novel treatment solutions are independent from biosimilar use and uptake
  • The time from market approval to first product sales for biosimilars is shorter than the time to first sales of novel medicines

Read the whitepaper here. 

December 2020

January 6, 2021

ASBM Paper is GaBI Journal’s Most-Read Biosimilars Article of 2020
According to the editors of the Journal of the Generics and Biosimilar Initiative (GaBI Journal), the most-viewed biosimilars article of 2020 was the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, co-authored by ASBM’s Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The article was published online in February 2020 and in Issue 2 of GaBI Journal’s print edition.

 

The paper examined biosimilar substitution policies across Europe, looking for commonalities among them which led to successful and sustainable biosimilar markets. The paper found that across Europe, biosimilars have:

  • Increased competition
  • Reduced unit cost of both originator and biosimilars compared to price levels prior to the arrival of biosimilars
  • Increased volume consumption of molecules with biosimilar competition thus expanding market access and optimizing patient dosing
  • Alleviated budget pressures by providing headroom to fund novel treatment solutions

While the policies by which this has been achieved vary somewhat between countries, the paper reveals that all major European markets share the following features:

  • Automatic substitution for biologicals is forbidden
  • All approved biologicals, i.e. originators and their biosimilars, are available on the market and are reimbursed when prescribed
  • Reimbursement decisions on novel treatment solutions are independent from biosimilar use and uptake
  • The time from market approval to first product sales for biosimilars is shorter than the time to first sales of novel medicines

Read the whitepaper here. 

 

 

 
WHO Survey: Lack of International Naming System is Barrier to Biosimilar Adoption

 

The World Health Organization (WHO) recently released the results of a 20-country survey which identified barriers to biosimilar adoption, the Center for Biosimilars reports. Entitiled “Regulatory challenges with biosimilars: an update from 20 countries”, the survey was a follow-up to one conducted ten years prior. While most of the issues identified in the earlier survey have been resolved, the authors report, a few remain including the lack of a consistent international standard for biologic naming. “There is still no consensus among countries on the naming and labeling of biosimilars,” they observe, and the WHO does not provide specific nomenclature for biosimilars.

 

Some countries including Canada and those in Europe, use the brand name and international nonproprietary name (INN) that latter of which is shared between the reference biologic and all its biosimilars. Other countries, including the United States and Japan use a suffix or other identifier as part of the name.

 

The authors stressed that naming and labeling are important for good pharmacovigilance, which they call “essential for establishing the safety and efficacy of interchangeability of biosimilars.” There are concerns, they say, about “prescription mix‐ups, unintentional switching, and questions on traceability.” To address these concerns, the authors recommended biosimilars be clearly identifiable, using a unique brand name with the international proprietary name, and the lot number be provided.

 

Following years of study on the issue including findings from the first 20-country survey, in 2014 the WHO’s INN Expert Group in fact proposed a voluntary naming standard which would address these concerns.

Under the proposed system, all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ, tied to the marketing authorization holder (MAH). Advantages of such a system include increased transparency, decreased likelihood of inadvertent or inappropriate substitution, improved traceability including more accurate attribution of adverse events to the correct product, and increased manufacturer accountability for their products.

While initially recieving strong support from 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 the absence of WHO making this system available, in 2015 the FDA adopted its own BQ-like suffix system.

In 2018, Australia adopted the European approach citing lack of WHO progress on implementation of the BQ system. Similarly, until 2019 Health Canada was in conversations with FDA about harmonizing distinct nomenclature systems regionally, but ultimately went with the brand+INN approach used in Europe, again citing lack of WHO action on distinct naming as a reason. However, both Canada and Australia have expressed their willingness to harmonize with the WHO standard were it to be made available.

 

Learn more about the BQ proposal here.

 

Read a summary of the paper’s findings here.

Read the paper here. 
 

 

 
 

FDA Approves 29th Biosimilar, Third for Rituximab
On December 17th, the US Food and Drug Administration (FDA) approved Rianbi (rituximab-arrx). Rianbi (rituximab-arrx) is manufactured by Amgen and the third FDA-approved biosimilar to Genentech’s Rituxan (rituximab). It is the third biosimilar FDA has approved in 2020 and the 29th approved in the past 5 years.

Read more about the successes FDA’s of the biosimilar program here.

 

Rianbi (rituximab-arrx) is indicated to treat adult patients with non-Hogkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

 

Rianbi (rituximab-arrx) will launch in January 2021. According to the manufacturer, its wholesale acquisition cost (WAC) will be 23.7% lower than the originator, 15.2% lower than Truximab (rituximab-abbs) and comparable to that of Ruxience (rituximab-pvvr). At launch its average sale price (ASP) will be 16.7% lower than the originator.

Learn more about the approval here. 

 

Read the label/packaging insert for Rianbi (rituximab-arrx) here. 

 

 
ASBM Presents to Rheumatologists in Saudi Arabia, Kuwait, Iraq

 

On December 9th, ASBM Advisory Board Chair Philip Schneider presented virtually to the Saudi Society for Rheumatology. The presentation was carried live to gatherings of rheumatologists in Riyadh, Saudi Arabia; Kuwait City, Kuwait; and Baghdad, Iraq.

 

Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and co-authored by Reilly and Schneider.

 

The paper examined biosimilar substitution policies across Europe, identifying factors which led to their successful and sustainable biosimilar markets.

 

The analysis identified six principles the authors refer to as the “Gold Standard”: 

 

  • Policies should be designed to incentivize and reward innovation in all types of biologicals.
  • Healthcare financing must take into account societal benefits derived from biological medicines, as well as the unique characteristics of biologicals.
  • Procurement practices must provide for multiple suppliers and a minimum term of 12 months.
  • Physicians must have autonomy to choose the most appropriate medicine for their patient, including making decisions on switching, which must also be consented to by the patient; no automatic substitution.
  • Mandatory brand-name prescribing to avoid unintended switches and a robust pharmacovigilance system to report adverse drug reactions (ADRs).
  • Policies with potential to undermine sustainability, such as measures which induce biosimilar uptake or promote preferential treatment, thereby limiting physician choice, should be avoided.

The paper also identified three “Must-Haves” for a sustainable biosimilar market:

  • Physicians should have the freedom to choose between off-patent originator biologicals and available biosimilars and to act in the best interest of their patients based on scientific evidence and clinical experience.
  • Tenders should be designed to include multiple value-based criteria beyond price, e.g. education, services, available dose strengths, and provide a sufficient broad choice (multi-winner tenders versus single-winner tenders) to ensure continuity of supply and healthy competition.
  • A level playing field between all participating manufacturers is the best way to foster competition; mandatory discounts which place artificial downward pressure on manufacturers do not engender a sustainable market environment.

Read the whitepaper here. 

 

 
Reminder: FDA Accepting Comments on Draft Guidance on Biosimilarity and Interchangeability

 

On November 19th, the US Food and Drug Administration (FDA) issued new Draft Guidance entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars.

 

These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.

 

When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
Comments will be accepted on the Draft Guidance until January 19, 2021.

Read the Draft Guidance here. 
Comments may be submitted here. 
UPCOMING EVENTS

 

ASCO Gastrointestinal Cancers Symposium

Virtual – January 15-17, 2021

 

DIA Latin America Regulatory Conference

Virtual – February 22-23, 2021

 

World Biosimilar Congress USA 2021

Virtual – March 29-31, 2021

 

WHO 72nd INN Consultation

Geneva, Switzerland – April 12, 2021

 

 

 

 
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