Posts – Page 10 – Safe Biologics

ASBM/Ohio State University Biosimilars CE Course Adds New Module on Patient Perspectives

November 1, 2022

In October, ASBM recorded the latest entry in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. This course module, entitled “Patient Perspectives on Biosimilars”, represents part 6 of the 7-part series covering a wide range of biosimilar policy issues.

In this module, participants will hear different perspectives from the patient community regarding biosimilars and how they are made available to patients. ASBM Steering Committee Member Andrew Spiegel will share his perspective as the head of two international patient organizations (the Global Colon Cancer Association and World Patients Alliance) as well as sharing the perspectives of several other patient advocacy experts from the U.S., Europe, Canada, and Australia.

Upon completion, participants will be able to:

Identify key benefits and challenges that biosimilars create for patients
Describe concerns that patients have under different biosimilar access scenarios.
Compare and contrast the roles of the physician and patient in treatment decisions in the different biosimilar markets examined.
Discuss tactics the patient community have used to improve access to biosimilars and control over treatment.=

The final entry in the CE series, entitled “PBM and Payer Practices” and featuring Immediate Past ASBM Chair Madelaine Feldman, MD FACR; will be available in the coming weeks.

View all the available OSU College of Pharmacy CE courses here. (registration required).

View the course outline here.

View a promotional trailer for the CE series here.

ASBM Physician Survey Featured in Oncology Journal

October 25, 2022

ASBM’s recent survey of 401 U.S. physicians was featured in the October issue of the journal Oncology Practice Management. The article discussed a poster presentation given by ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF at the Drug Information Association Global Annual Meeting (DIA 2022) on June 20th, in Chicago, IL. View the poster here. The survey findings consistently reflected the high importance to respondents of preserving patient and physician choice regarding treatment decisions. From the article:

Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate.

Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost.

When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure.

Read the Oncology Practice Management article here.

View Dr. McKibbin’s poster presentation here.

View or download the poster here.

ASBM Physician Survey Featured in Oncology Journal

October 25, 2022

ASBM’s recent survey of 401 U.S. physicians was featured in the October issue of the journal Oncology Practice Management. The article discussed a poster presentation given by ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF at the Drug Information Association Global Annual Meeting (DIA 2022) on June 20th, in Chicago, IL. View the poster here. The survey findings consistently reflected the high importance to respondents of preserving patient and physician choice regarding treatment decisions. From the article:

Despite expressing a high level of confidence when it comes to switching to or prescribing a biosimilar, 58% of survey respondents said they were uncomfortable with third-party substitution for nonmedical reasons related to cost or coverage. In addition, 69% of respondents said it was “very important or critical” that patients and physicians collaborate on the decision to choose the most suitable biosimilar and 67% said that it was “very important or critical” that they were able to prevent a substitution they considered inappropriate.

Results of the survey also showed that the majority (71%) of physicians felt that payers should reimburse several biologics in a specific class, including the reference drug with its biosimilars, and 74% felt that private and public payers should base their decisions regarding biosimilars coverage on factors other than cost.

When asked about preferred biosimilar access, 81% said that their patients could be best served under the type of scenario used throughout most of Western Europe, in which biosimilars and reference products are both reimbursed and biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not allowed. Only 8% supported an access scenario used in several Canadian provinces, in which only a preferred, government-selected product is reimbursed and to which both new and stable patients must be switched. Eleven percent said that they are unsure.

Read the Oncology Practice Management article here.

View Dr. McKibbin’s poster presentation here.

View or download the poster here.

September 2022 Newsletter

October 24, 2022

EMA & HMA Declare All Biosimilars “Interchangeable”In a joint statement dated September 19th, 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies declared that all biosimilars approved in the European Union are interchangeable with their reference medicines. According to the statement, “interchangeable” means “the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.”

This is distinct from the U.S. designation of an “interchangeable biosimilar’, which carries a specific statutory and legal meaning. In order to receive this designation, biosimilar manufacturers must provide additional data to the FDA- to demonstrate that a patient repeatedly switched between a reference product and its biosimilar can expect the same result, without any additional risks, relative to a patient who was not switched.

Under U.S. state law, only “interchangeable” biosimilars can be substituted at the pharmacy without the prescribing physician’s prior approval (although the prescriber must be informed of the substitution and may prevent substitutions.)

The EMA does not require such additional data or switching studies to call a biosimilar “interchangeable”.

In addition, the EMA/HMA statement does not weigh in on decisions regarding substitution and notes that biosimilar substitution policy is left to individual member states. In nearly every European country, these decisions rest with the prescribing physician.

Read the EMA/HMA Statement here.

Learn about the FDA’s interchangeable biosimilars here.

GaBI Publishes Summary of ASBM Webinar on Biosimilar Success Factors

The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The report summarizes the presentations from the June 29th webinar which examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US”. View the webinar here.

The report also addresses audience questions that were unable to be answered during the programs due to time constraints.

GaBI is also preparing a report on the second webinar, hosted July 20th, 2022 entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”. The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship. Watch video of the Non-Medical Switching webinar here.

These webinars are the first two in a series. The next topic will be “Ophthalmic Biosimilars” in November 2022. More information will be available soon.

Read GaBI’s report on Webinar #1 here.

Biosimilar Discussion Continues With ASBM/AI Arthritis Talk Show

In September, the International Foundation for Autoimmune & Autoinflammatory Diseases (AI Arthritis) released an episode of its AI Arthritis Voices 360 Talk Show podcast entitled “Biosimilars:What Patients Need to Know”. Several ASBM representatives joined AI Arthritis CEO Tiffany Westrich-Robertson to discuss policy issues surrounding biosimilars and how these affect patients. ASBM was represented in the discussion by Executive Director Michael Reilly; Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association (GCCA).

Watch Video Clips From the Podcast:

What is a Biosimilar?

Biosimilars vs. Generics

First Steps When Being Told You Are Switching to a Biosimilar

Transparency in Biosimilars

But the conversation doesn’t stop there. Members of the international patient community are now beginning to engage in the discussion by recording “360its” – an unlimited number of spin off segments to the original episode that can be in any format (video, social media posts, TikTok, Twitter Chats, email blasts, in-person events, etc.)

Listen to Breakout Conversations Here:

Physician Involvement

Data for Switching

Interchangeable Biosimilars

Patient Resources: Biosimilar Training Program

The Best Interest of the Patient

Look for additional content in the coming weeks!

Watch or listen to Episode 77 of the AI Arthritis Voices 360 podcast here.

December 7th: Watch Party for ASBM-Sponsored Biosimilar Training Program

On December 7th, the International Foundation for Autoimmune & Autoinflammatory Diseases (AI Arthritis) will be hosting a Peer-Led Biosimilars Webinar Watch Party at 1pm ET/USA). During the event, patient leaders will rewatch segments from the May 10-11, 2022 Biosimilars Training Program for Patient Advocates. The program was presented by the Global Colon Cancer Association and co-sponsored by ASBM. Several ASBM representatives led sessions, including:

Introduction to Biologics and Biosimilars –Philip Schneider, MS, FASHP, FFIP; ASBM Advisory Board Chair
Physician Perspectives on Biosimilars – Ralph McKibbin, MD, FACP, FACG, AGAF; ASBM Chairman
US Payer Practices – Madelaine Feldman, MD, FACR; President, Coalition of State Rheumatology Societies and Immediate Past Chair of ASBM.
Biosimilar Substitution Around the World – Philip Schneider, MS, FASHP, FFIP; ASBM Advisory Board Chair
Biosimilar Pharmacovigilance – Philip Schneider, MS, FASHP, FFIP; ASBM Advisory Board Chair
US Patient Perspectives – Andrew Spiegel, Executive Director of GCCA and ASBM Steering Committee Member

During the watch party, patient leaders will host break out conversations based on the topics raised and discuss the Patient Advocacy Toolkit, which teaches patients how to weigh in on the policy issues affecting their treatment.

Register for the Biosimilar Training Program Watch Party here.

EMA & HMA Declare All Biosimilars “Interchangeable”

In a joint statement dated September 19th, 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies declared that all biosimilars approved in the European Union are interchangeable with their reference medicines. According to the statement, “interchangeable” means “the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.”

This is distinct from the U.S. designation of an “interchangeable biosimilar’, which carries a specific statutory and legal meaning. In order to receive this designation, biosimilar manufacturers must provide additional data to the FDA- to demonstrate that a patient repeatedly switched between a reference product and its biosimilar can expect the same result, without any additional risks, relative to a patient who was not switched.

Under U.S. state law, only “interchangeable” biosimilars can be substituted at the pharmacy without the prescribing physician’s prior approval (although the prescriber must be informed of the substitution and may prevent substitutions.)

The EMA does not require such additional data or switching studies to call a biosimilar “interchangeable”.

In addition, the EMA/HMA statement does not weigh in on decisions regarding substitution and notes that biosimilar substitution policy is left to individual member states. In nearly every European country, these decisions rest with the prescribing physician.

Read the EMA/HMA Statement here.

Learn about the FDA’s interchangeable biosimilars here.

USP/FDA Infographic Release: Biosimilars: Are They the Same Quality?

On September 16th, the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) released an educational resource to help healthcare practitioners explain to patients how biosimilar biological products are high quality products and safe and effective treatment options.

USP is an independent, non-governmental, not-for-profit organization that sets quality, purity and strength standards for certain medicines, food ingredients and other products sold in the United States.

This resource explains the steps involved to help ensure that biosimilars are the same quality as their reference product, and how biosimilars can improve patient access to quality medicines.

View the infographic here.

FDA Approves 38th Biosimilar, Sixth for Pegfilgrastim

On September 1st, the FDA approved stimufend (pegfilgrastim-fpgk), a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim), which is used to reduce the incidence of neutropenia in patients undergoing chemotherapy. The approval marks the sixth biosimilar approved for pegfilgrastim, and the 38th biosimilar approval overall.

Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Stimufend was approved as a biosimilar based on data demonstrating that it is highly similar to the FDA-approved biological reference product containing pegfilgrastim, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
Stimufend is administered via subcutaneous injection once per chemotherapy cycle. The injection is supplied in a single-dose pre-filled syringe.

Read more about the approval here.

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

UPCOMING EVENTS

8th Biosimilar Medicines Conference

Brussels, Belgium – October 6-7, 2022

WHO 75th INN Consultation

Geneva, Switzerland – October 18, 2022

7th Annual National Policy & Advocacy Summit on Biologics

Washington, DC (Register here) – October 18, 2022

ASBM-GaBI Webinar #3: Ophthalmic Biosimilars

Virtual – November 2022 (Date TBD)

Festival of Biologics Europe 2022

Basel, Switzerland – November 2-4, 2022

Biosimilars Training Program Watch Party

Virtual (Register here) – December 7, 2022

September 2022 Newsletter

October 24, 2022

GaBI Publishes Summary of ASBM Webinar on Biosimilar Success Factors

The Generics and Biosimilars Initiative (GaBI) has published a report on the first of two webinars the organization recently co-hosted with ASBM. The report summarizes the presentations from the June 29th webinar which examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US”. View the webinar here.

The report also addresses audience questions that were unable to be answered during the programs due to time constraints.

GaBI is also preparing a report on the second webinar, hosted July 20th, 2022 entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”. The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship. Watch video of the Non-Medical Switching webinar here.

These webinars are the first two in a series. The next topic will be “Ophthalmic Biosimilars” in November 2022. More information will be available soon.

Read GaBI’s report on Webinar #1 here.

Biosimilar Discussion Continues With ASBM/AI Arthritis Talk Show

In September, the International Foundation for Autoimmune & Autoinflammatory Diseases (AI Arthritis) released an episode of its AI Arthritis Voices 360 Talk Show podcast entitled “Biosimilars:What Patients Need to Know”. Several ASBM representatives joined AI Arthritis CEO Tiffany Westrich-Robertson to discuss policy issues surrounding biosimilars and how these affect patients. ASBM was represented in the discussion by Executive Director Michael Reilly; Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association (GCCA).

Watch Video Clips From the Podcast:

What is a Biosimilar?

Biosimilars vs. Generics

First Steps When Being Told You Are Switching to a Biosimilar

Transparency in Biosimilars

But the conversation doesn’t stop there. Members of the international patient community are now beginning to engage in the discussion by recording “360its” – an unlimited number of spin off segments to the original episode that can be in any format (video, social media posts, TikTok, Twitter Chats, email blasts, in-person events, etc.)

Listen to Breakout Conversations Here:

Physician Involvement

Data for Switching

Interchangeable Biosimilars

Patient Resources: Biosimilar Training Program

The Best Interest of the Patient

Look for additional content in the coming weeks!

Watch or listen to Episode 77 of the AI Arthritis Voices 360 podcast here.

December 7th: Watch Party for ASBM-Sponsored Biosimilar Training Program

On December 7th, the International Foundation for Autoimmune & Autoinflammatory Diseases (AI Arthritis) will be hosting a Peer-Led Biosimilars Webinar Watch Party at 1pm ET/USA). During the event, patient leaders will rewatch segments from the May 10-11, 2022 Biosimilars Training Program for Patient Advocates. The program was presented by the Global Colon Cancer Association and co-sponsored by ASBM. Several ASBM representatives led sessions, including:

Introduction to Biologics and Biosimilars –Philip Schneider, MS, FASHP, FFIP; ASBM Advisory Board Chair
Physician Perspectives on Biosimilars – Ralph McKibbin, MD, FACP, FACG, AGAF; ASBM Chairman
US Payer Practices – Madelaine Feldman, MD, FACR; President, Coalition of State Rheumatology Societies and Immediate Past Chair of ASBM.
Biosimilar Substitution Around the World – Philip Schneider, MS, FASHP, FFIP; ASBM Advisory Board Chair
Biosimilar Pharmacovigilance – Philip Schneider, MS, FASHP, FFIP; ASBM Advisory Board Chair
US Patient Perspectives – Andrew Spiegel, Executive Director of GCCA and ASBM Steering Committee Member

During the watch party, patient leaders will host break out conversations based on the topics raised and discuss the Patient Advocacy Toolkit, which teaches patients how to weigh in on the policy issues affecting their treatment.

Register for the Biosimilar Training Program Watch Party here.

EMA & HMA Declare All Biosimilars “Interchangeable”

In a joint statement dated September 19th, 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies declared that all biosimilars approved in the European Union are interchangeable with their reference medicines. According to the statement, “interchangeable” means “the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.”

This is distinct from the U.S. designation of an “interchangeable biosimilar’, which carries a specific statutory and legal meaning. In order to receive this designation, biosimilar manufacturers must provide additional data to the FDA- to demonstrate that a patient repeatedly switched between a reference product and its biosimilar can expect the same result, without any additional risks, relative to a patient who was not switched.

Under U.S. state law, only “interchangeable” biosimilars can be substituted at the pharmacy without the prescribing physician’s prior approval (although the prescriber must be informed of the substitution and may prevent substitutions.)

The EMA does not require such additional data or switching studies to call a biosimilar “interchangeable”.

In addition, the EMA/HMA statement does not weigh in on decisions regarding substitution and notes that biosimilar substitution policy is left to individual member states. In nearly every European country, these decisions rest with the prescribing physician.

Read the EMA/HMA Statement here.

Learn about the FDA’s interchangeable biosimilars here.

USP/FDA Infographic Release: Biosimilars: Are They the Same Quality?

On September 16th, the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) released an educational resource to help healthcare practitioners explain to patients how biosimilar biological products are high quality products and safe and effective treatment options.

USP is an independent, non-governmental, not-for-profit organization that sets quality, purity and strength standards for certain medicines, food ingredients and other products sold in the United States.

This resource explains the steps involved to help ensure that biosimilars are the same quality as their reference product, and how biosimilars can improve patient access to quality medicines.

View the infographic here.

FDA Approves 38th Biosimilar, Sixth for Pegfilgrastim

On September 1st, the FDA approved stimufend (pegfilgrastim-fpgk), a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim), which is used to reduce the incidence of neutropenia in patients undergoing chemotherapy. The approval marks the sixth biosimilar approved for pegfilgrastim, and the 38th biosimilar approval overall.

Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Stimufend was approved as a biosimilar based on data demonstrating that it is highly similar to the FDA-approved biological reference product containing pegfilgrastim, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
Stimufend is administered via subcutaneous injection once per chemotherapy cycle. The injection is supplied in a single-dose pre-filled syringe.

Read more about the approval here.

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

UPCOMING EVENTS

8th Biosimilar Medicines Conference

Brussels, Belgium – October 6-7, 2022

WHO 75th INN Consultation

Geneva, Switzerland – October 18, 2022

7th Annual National Policy & Advocacy Summit on Biologics

Washington, DC (Register here) – October 18, 2022

ASBM-GaBI Webinar #3: Ophthalmic Biosimilars

Virtual – November 2022 (Date TBD)

Festival of Biologics Europe 2022

Basel, Switzerland – November 2-4, 2022

Biosimilars Training Program Watch Party

Virtual (Register here) – December 7, 2022

Amgen Releases Full 2022 Biosimilar Trends Report

October 20, 2022

In October, Amgen released its full 2022 Biosimilar Trends Report. The report’s findings had been previewed earlier this year by Amgen’s Global Biosimilars Commercial Lead, Chad Pettit at a June 29th webinar hosted by ASBM and GaBI Journal.

View the webinar “Key Factors for Successful Uptake of Biosimilar Markets” here. Read GaBI Journal’s Meeting Report here.

The full report further documents the tremendous success of the U.S. biosmilars program in promoting competition, increasing biosimilar uptake, and generating savings for the U.S. health system. From the report:

To date in the US, 39 biosimilars have received regulatory approval, and 22 products have been launched. These launches have helped create an estimated $21 billion in savings for the healthcare system over the past 6 years.

Biosimilars have gained significant U.S. market share in the majority of therapeutic areas where they have been introduced: 80% for filgrastim trastuzumab and bevacizumab biosimilars; 60% for rituximab biosimilars; and 40% for infliximab, pegfilgrastim, and erythropoietin-stimulating agent (ESA) biosimilars.
Biosimilars are attaining significant market share more quickly: for therapeutic areas with biosimilars launched in the last 3 years, the average share was 74%…prior to 2019, the average share after 3 years was 38%.

Medicare Part B reimburses providers for biosimilars at the biosimilar’s Average Sales Price (ASP) plus a 6% addon of the reference biologic’s ASP. In other words, Congress kept the field level by providing physicians the same add-on amount regardless of whether they prescribe a reference product or a biosimilar. This helps all manufacturers compete on equal terms.

The report also emphasized that continued stakeholder education was critical to the market’s continued success:

As biosimilars expand into new therapeutic areas and enter the pharmacy benefit, education will continue to be critical to instill patient, provider, and pharmacist confidence in the role of biosimilars as viable and integral treatment options.

Read the Amgen 2022 Biosimilar Trends Report here.
View ASBM’s Key Success Factors Webinar here and access speaker presentations here.
Read GaBI Journal’s Meeting Report about the webinar here.

ASBM’s Schneider Discusses Pharmacist, PBM Role at National Policy & Advocacy Summit on Biologics

October 19, 2022

On October 19th, ASBM Advisory Board Chair Philip Schneider participated in the 7th Annual National Policy & Advocacy Summit on Biologics, The event was hosted in Washington, DC by the Biologics Prescribers Collaborative and was also streamed online.

Professor Schneider appeared on the opening panel discussion entitled

“The Emerging Biologics Landscape”, which also featured Chad Pettit, Executive Director of Marketing at Amgen, and Wesley Mizutani, MD, a rheumatologist with Optum Medical Group. The discussion was moderated by David Charles, MD, founder of the Alliance for Patient Access.

Schneider discussed the pharmacist role regarding biosimilars, which includes keeping effectiveness & safety at the forefront of treatment decisions as our health system work to make responsible use of limited resources.

Another major topic of discussion was the role of pharmacy benefit managers (PBMs) in treatment decision-making and their impact on patient access to care. PBMs have eveloved from entities which simply processed claims, Schneider explained, into powerful entities with the ability to move market share through formulary design and rebates. This disrupts the autonomy of prescribers when a third party is effectively making clinical decisions. Pharmacists also feel they are losing control, as economics is often emphasized over medication effectiveness and patient health. Putting money into an intermediary often drives cost upward, Schneider observed.

View the panel discussion, “The Emerging Biologics Landscape”, followed by the rest of the event here.

ASBM’s Schneider Discusses Pharmacist, PBM Role at National Policy & Advocacy Summit on Biologics

October 19, 2022

On October 19th, ASBM Advisory Board Chair Philip Schneider participated in the 7th Annual National Policy & Advocacy Summit on Biologics, The event was hosted in Washington, DC by the Biologics Prescribers Collaborative and was also streamed online.

Professor Schneider appeared on the opening panel discussion entitled

“The Emerging Biologics Landscape”, which also featured Chad Pettit, Executive Director of Marketing at Amgen, and Wesley Mizutani, MD, a rheumatologist with Optum Medical Group. The discussion was moderated by David Charles, MD, founder of the Alliance for Patient Access.

Schneider discussed the pharmacist role regarding biosimilars, which includes keeping effectiveness & safety at the forefront of treatment decisions as our health system work to make responsible use of limited resources.

Another major topic of discussion was the role of pharmacy benefit managers (PBMs) in treatment decision-making and their impact on patient access to care. PBMs have eveloved from entities which simply processed claims, Schneider explained, into powerful entities with the ability to move market share through formulary design and rebates. This disrupts the autonomy of prescribers when a third party is effectively making clinical decisions. Pharmacists also feel they are losing control, as economics is often emphasized over medication effectiveness and patient health. Putting money into an intermediary often drives cost upward, Schneider observed.

View the panel discussion, “The Emerging Biologics Landscape”, followed by the rest of the event here.

ASBM Presents at WHO 75th INN Consultation

October 18, 2022

On October 18th, ASBM participated in the World Health Organization’s 75th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the nineteenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.

From the WHO’s Executive Summary of the 74th INN Consultation, at which ASBM presented in April 2022:

ASBM noted that it was a decade ago that the WHO recognised the need to improve biological PV and that a WHO survey in 2020 found that the lack of an international standard remains an issue of concern that can lead to PV problems. Several early supporters of universal distinct naming have gone their own way due to lack of WHO action, but have expressed willingness to harmonize should the WHO act. ASBM will continue to work with regulators worldwide to move a global nomenclature policy forward…The Chair added that the Expert Group is looking at how to progress naming for these biologics and that the concept that was developed previously, viz., the biological qualifier (BQ), will be taken forward and discussed at WHO management level. Thus, the continued presence of ASBM at these sessions has not been in vain.

Read the WHO’s summary of the 74th INN Consultation here.

ASBM, IFA Observe World Sight Day 2022

October 13, 2022

World Sight Day is observed worldwide every year on the second Thursday of October. This World Health Organization-designated day falls on 13 October this year. The purpose of World Sight Day is to increase public awareness about blindness, vision impairment, vision care, and ocular issues. The WHO estimates that 1 billion people worldwide suffer from near or distant vision impairment due to delayed diagnosis and treatment. Although it can affect individuals of any age group, those over 50 years of age are more likely to experience it. Blindness or vision impairment can limit a person’s everyday life, prospects for employment and other aspects of their personal lives, including their ability to travel.

ASBM is quoted in a press release about World Sight Day from our partner the International Federation on Ageing (IFA) which is leading an educational campaign regarding the arrival of ophthalmic biosimilars in Canada:

In advance of World Sight Day on October 13th, the International Federation on Ageing (IFA) in partnership with national and global organizations wants to drive action for eye care, to improve the situation for those impacted by vision loss and blindness, now, and in the future. While global agencies support initiatives to improve, restore, and maintain vision for people around the world, many Canadians need to prepare for policy changes about their eye treatment that have the potential to impact patient and physician autonomy.

From the press release and informational packet.

“The Alliance for Safe Biologic Medicines (ASBM) supports the introduction of biosimilars as an important tool for offering patients new therapeutic options and reducing healthcare costs. The tremendous success of biosimilars in European markets has shown that countries need not sacrifice physician and patient’s choice to enjoy substantial savings. This is accomplished through competition between many reimbursed products, rather than forced switches. Physicians and patients in Canada deserve no less – yet they are increasingly seeing their choice restricted rather than expanded. With the arrival of ophthalmic biosimilars, we must heed the concerns of these physicians and their patients regarding unnecessary switching, so that we do not risk long-term harm to patients for short-term savings” states Michael Reilly, Executive Director, ASBM.

Read the IFA’s educational document- including a backgrounder on ophthalmic biosimilars, here.