ASBM Presents at Festival of Biologics 2022 Europe

November 8, 2022

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

img_0471

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

  • 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
  • 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
  • Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.


ASBM Presents at Festival of Biologics 2022 Europe

November 8, 2022

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

img_0471

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

  • 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
  • 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
  • Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.

View Professor Schneider’s Festival of Biologics presentation here.

View ASBM’s Festival of Biologics poster here. 


ASBM Presents at Festival of Biologics 2022 Europe

November 8, 2022

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

img_0471

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

  • 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
  • 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
  • Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.

View Professor Schneider’s Festival of Biologics presentation here.

View ASBM’s Festival of Biologics poster here. 


ASBM Submits Comments on Minnesota Health Plan Legislation

November 3, 2022

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment letter: 

It is our view that HF 1516/SF 990 while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients.

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

Read ASBM’s comment letter here.


ASBM Submits Comments on Minnesota Health Plan Legislation

November 3, 2022

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment letter: 

It is our view that HF 1516/SF 990 while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients.

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

Read ASBM’s comment letter here.


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:

  1. Identify key benefits and challenges that biosimilars create for patients
  2. Describe concerns that patients have under different biosimilar access scenarios.
  3. Compare and contrast the roles of the physician and patient in treatment decisions in the different biosimilar markets examined.
  4. 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

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. 

 

 

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. 

 

 

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

 

 


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