ASBM Presents at 16th Biosimilars Congregation

January 30, 2022

On December 9th, ASBM participated in the 16th Biosimilar Congregation, which focused on the Indian biosimilars market. By 2030, India is expected to become the sixth-largest market for pharmaceuticals, and has already firmly established itself in the global biopharmaceutical market. Many Indian pharmaceutical companies are preparing to step into the global biosimilars market.

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, who moderated a panel on Market Access. The panel, comprised largely of representatives from Indian pharmaceutical companies, examined key challenges to gaining market access and sought to identify best practices for successfully entering tomorrow’s biosimilar market.

Topics discussed included current trends in biosimilar markets, the importance of sustainable pricing and reimbursement practices, ethical concerns, and strategies for overcoming market barriers.

A major takeaway from the discussions was that buidling confidence among physicians and patients was critical to success. To that end, panelists were strongly supportive of providing data demonstrating safety and efficacy of Indian biosimilars, including studies which showed patients may switch safely between originator products and biosimilars.

Learn more about the 16th Biosimilars Congregation here.

ASBM Letter to Congress: Paying Physicians to Prescribe Government-Preferred Biosimilars Undermines Patient-Physician Relationship

January 30, 2022

On December 2nd, ASBM sent a letter to House leaders reiterating our opposition to a proposal that would undermine the patient-physician relationship and distort the making of treatment decisions. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. From the letter:

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally.

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.

We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

Read ASBM’s full letter here.

Read the current text of H.R. 5376 here.

November 2021

January 5, 2022

OSU College of Pharmacy Launches ASBM-Developed CE Course on Biologics and Biosimilars

 

The Ohio State University College of Pharmacy is now offering a 1-hour Continuing Education (CE) course entitled Biologics and Biosimilars: and Introduction. The course is presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.

 

The course is a primer on biologics and biosimilars, examining how these medicines are developed and approved as well as delving into policy considerations which affect pharmacy practice. The include the role of analytics and clinical trials in approval, biosimilar substitution practices, and the concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.

 

The course is the first in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including non-medical switching, biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.

 

View the first OSU CE Course here (registration required). 

 

Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here. 

 

 
ASBM Chairman Moderates Webinar at DDNC Policy Conference

 

On November 15th, ASBM Chairman Ralph McKibbin, MD moderated a panel discussion at the Digestive Disease National Coalition’s Fall policy-setting forum.

The Fall Forum ran from November 15th-19th and gathered together policymakers, caregivers, and patients to discuss the latest developments in digestive disease policy. The webinar included an overview of DDNC funding priorities, presentations from DDNC member organizations, and an informational session on the Safe Step Act.

 

The Safe Step Act is a bill which would regulate the utilization-management technique known as “step therapy”- where patients are required by insurers or pharmacy benefit managers to deny patients access to the medicines selected by their physicians, until they have failed one or more lower-cost treatments.  Alaska Senator Lisa Murkowski, lead sponsor of the bill, presented.
A major topic of discussion at the five-day conference was a recent paper on step therapy entitled “Variation In Use And Content Of Prescription Drug Step Therapy Protocols, Within And Across Health Plans”. From the paper’s abstract:
Insurers limit the use of certain prescription drugs by requiring step therapy—that is, by allowing access only after alternatives have been tried and have failed. Using data from seventeen of the largest US commercial health plans, we examined step therapy protocols that determined patients’ eligibility for specialty drugs and identified ten diseases that are often subject to that requirement.
The authors’ analysis found that that 55.6 percent of step therapy protocols were more stringent than the corresponding clinical guidelines, and that these protocols varied widely both within and between. The authors observed that:
“These findings raise questions about potentially overly restrictive step therapy protocols, as well as concerns that variability across health plans makes protocols onerous for patients and practitioners alike. The findings thus suggest the need for state and federal legislation.”

 
ASBM Presents at World Biosimilar Congress Europe

 

From November 9th-11th, ASBM participated in the World Biosimilar Congress 2021 Europe, held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association (GCCA).

 

The theme of the three-day meeting was “Celebrating 15 years of Biosimilars in Europe.”  Professor Schneider chaired the Keynote Panel Discussion titled “Regulatory lessons learned from the past 15 years and what can regulatory guidelines do to improve access going forward.”
Members of the panel included a representatives from the European Medicines (EMA) and drug manufacturers. There was a robust conversation  surrounding the issue of interchangeability of biosimilars and the role clinical trials should play in market authorization. It was also agreed that physician and patient involvement in developing regulatory guidelines is important and strong pharmacovigilance programs are essential.
There were several sessions on the topic of sustainability that addressed the need for balance in the efforts to contain costs while maintaining a competitive marketplace by increasing the number of biosimilars and creating new reference products.  Schneider chaired the sessions on this topic, gave a presentation titled “Problems with Pharmacovigilance Programs: an Opportunity for Improvement,” and chaired a panel discussion “Creating a sustainable future for biosimilars.” Topics discussed in the panel included the need to included factors other than price such as drug administration devices and supply chain reliability in tender decisions and the pros and cons of gain-sharing programs that are intended to create the incentive to use biosimilars in the clinical setting.
Andrew Spiegel chaired a 3-hour session and hosted a Roundtable on Biosimilars in Oncology, at which the topic of forced biosimilar switching was discussed. The oncologists present expressed their strong opposition to the practice.
Spiegel also hosted two Fireside Chats during the meeting. The first was with Antonella Cardone, executive director of the European Cancer Patient Coalition. Its theme was ‘The Importance of Biosimilars in Oncology” and featured patient survey data. “It was clear from the European patient community is largely in alignment with ASBM members on opposing forced switching and preferring to make treatment decisions with their physicians, said Mr. Spiegel. The second Fireside Chat was with a representative from a biosimilar manufacturer, Sundar Ramanan, entitled ‘Promoting Equitable Access of Biosimilars Across Therapeutic Areas.”

 

Read more about the World Biosimilar Congress 2021 Europe here. 

 

 

 
FDA Official Gives Update on U.S. Biosimilar Program

 

On November 8th, Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), gave an update on CDER’s biosimilar development program. The remarks were made at the meeting of the Association for Accessible Medicines’ (AAM) GRx+Biosim conference, held virtually.

 

Dr. Corrigan-Curay called the biosimilar product development program a “great success” in terms of approvals, uptake in certain sectors, and engagement. She said that as of November, FDA has approved 31 biosimilars for 11 reference products. This figure is up from the 29 biosimilars approved in May 2021.

 

These approvals include two interchangeable products. The first interchangeable biosimilar was Mylan’s Semglee (insulin glargine-yfgn) followed by Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). Interchangeable biosimilar products may be substituted at the pharmacy level for their reference products without prescriber intervention, much as generic drugs may be substituted at the pharmacy level for reference-listed drugs.

 

FDA is also seeing an “increasing uptake of this program in oncology,” added Corrigan-Curay. She added that while there is more uptake of the program in the oncology space, adoption is less prevalent in other treatment areas.

 

Read more about the update here. 

 

 
ASBM’s Madelaine Feldman Testifies at House Oversight Committee

 

On November 17th, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR testified at a public hearing of the Congressional Oversight Committee. Entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, the hearing examined the role of PBMs in contributing to higher drug prices. From Dr. Feldman’s testimony:

 

The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…

 

High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

 

Read more about the Oversight Committee hearing here.
Read Dr. Feldman’s full testimony here. 

 

 
Gewanter Named President-Elect of Medical Society of Virginia

 

Past ASBM Chairman Harry Gewanter, MD, MACR was recently named to the Board of Directors of the Medical Society of Virginia as President-elect.

The nomination was made at the society’s 2021 House of Delegates meeting.

Dr. Gewanter will assume the MSV presidency for a one-year term beginning at the MSV’s next annual meeting in October 2022.

 

Dr. Gewanter served as ASBM’s Chairman from 2014-2017 and continues to serve as a member of ASBM’s International Advisory Board. While ASBM chair, he provided valuable testimony to many state legislatures as they implemented biosimilar substitution legislation.

 

He is a graduate of Duke University and received his medical training at Wayne State University. He conducted his pediatric internship and residency at the University of Rochester/Strong Memorial Hospital. He has practiced in Richmond, Virginia since 1983. After more than three decades, Dr. Gewanter decided to retire from clinical practice to focus his efforts advocating for systemic change for people with disabilities. He is especially passionate on issues affecting children and youth with special health care needs.
Read the MSV’s announcement here.

 
UPCOMING ASBM EVENTS

 

16th Biosimilars Congregation 2021

Virtual – December 9, 2021

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

74th INN Consultation

Geneva, Switzerland – April 5-8, 2022

 

November 2021

January 5, 2022

OSU College of Pharmacy Launches ASBM-Developed CE Course on Biologics and Biosimilars

 

The Ohio State University College of Pharmacy is now offering a 1-hour Continuing Education (CE) course entitled Biologics and Biosimilars: and Introduction. The course is presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.

 

The course is a primer on biologics and biosimilars, examining how these medicines are developed and approved as well as delving into policy considerations which affect pharmacy practice. The include the role of analytics and clinical trials in approval, biosimilar substitution practices, and the concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.

 

The course is the first in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including non-medical switching, biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.

 

View the first OSU CE Course here (registration required). 

 

Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here. 

 

 
ASBM Chairman Moderates Webinar at DDNC Policy Conference

 

On November 15th, ASBM Chairman Ralph McKibbin, MD moderated a panel discussion at the Digestive Disease National Coalition’s Fall policy-setting forum.

The Fall Forum ran from November 15th-19th and gathered together policymakers, caregivers, and patients to discuss the latest developments in digestive disease policy. The webinar included an overview of DDNC funding priorities, presentations from DDNC member organizations, and an informational session on the Safe Step Act.

 

The Safe Step Act is a bill which would regulate the utilization-management technique known as “step therapy”- where patients are required by insurers or pharmacy benefit managers to deny patients access to the medicines selected by their physicians, until they have failed one or more lower-cost treatments.  Alaska Senator Lisa Murkowski, lead sponsor of the bill, presented.
A major topic of discussion at the five-day conference was a recent paper on step therapy entitled “Variation In Use And Content Of Prescription Drug Step Therapy Protocols, Within And Across Health Plans”. From the paper’s abstract:
Insurers limit the use of certain prescription drugs by requiring step therapy—that is, by allowing access only after alternatives have been tried and have failed. Using data from seventeen of the largest US commercial health plans, we examined step therapy protocols that determined patients’ eligibility for specialty drugs and identified ten diseases that are often subject to that requirement.
The authors’ analysis found that that 55.6 percent of step therapy protocols were more stringent than the corresponding clinical guidelines, and that these protocols varied widely both within and between. The authors observed that:
“These findings raise questions about potentially overly restrictive step therapy protocols, as well as concerns that variability across health plans makes protocols onerous for patients and practitioners alike. The findings thus suggest the need for state and federal legislation.”

 
ASBM Presents at World Biosimilar Congress Europe

 

From November 9th-11th, ASBM participated in the World Biosimilar Congress 2021 Europe, held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association (GCCA).

 

The theme of the three-day meeting was “Celebrating 15 years of Biosimilars in Europe.”  Professor Schneider chaired the Keynote Panel Discussion titled “Regulatory lessons learned from the past 15 years and what can regulatory guidelines do to improve access going forward.”
Members of the panel included a representatives from the European Medicines (EMA) and drug manufacturers. There was a robust conversation  surrounding the issue of interchangeability of biosimilars and the role clinical trials should play in market authorization. It was also agreed that physician and patient involvement in developing regulatory guidelines is important and strong pharmacovigilance programs are essential.
There were several sessions on the topic of sustainability that addressed the need for balance in the efforts to contain costs while maintaining a competitive marketplace by increasing the number of biosimilars and creating new reference products.  Schneider chaired the sessions on this topic, gave a presentation titled “Problems with Pharmacovigilance Programs: an Opportunity for Improvement,” and chaired a panel discussion “Creating a sustainable future for biosimilars.” Topics discussed in the panel included the need to included factors other than price such as drug administration devices and supply chain reliability in tender decisions and the pros and cons of gain-sharing programs that are intended to create the incentive to use biosimilars in the clinical setting.
Andrew Spiegel chaired a 3-hour session and hosted a Roundtable on Biosimilars in Oncology, at which the topic of forced biosimilar switching was discussed. The oncologists present expressed their strong opposition to the practice.
Spiegel also hosted two Fireside Chats during the meeting. The first was with Antonella Cardone, executive director of the European Cancer Patient Coalition. Its theme was ‘The Importance of Biosimilars in Oncology” and featured patient survey data. “It was clear from the European patient community is largely in alignment with ASBM members on opposing forced switching and preferring to make treatment decisions with their physicians, said Mr. Spiegel. The second Fireside Chat was with a representative from a biosimilar manufacturer, Sundar Ramanan, entitled ‘Promoting Equitable Access of Biosimilars Across Therapeutic Areas.”

 

Read more about the World Biosimilar Congress 2021 Europe here. 

 

 

 
FDA Official Gives Update on U.S. Biosimilar Program

 

On November 8th, Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), gave an update on CDER’s biosimilar development program. The remarks were made at the meeting of the Association for Accessible Medicines’ (AAM) GRx+Biosim conference, held virtually.

 

Dr. Corrigan-Curay called the biosimilar product development program a “great success” in terms of approvals, uptake in certain sectors, and engagement. She said that as of November, FDA has approved 31 biosimilars for 11 reference products. This figure is up from the 29 biosimilars approved in May 2021.

 

These approvals include two interchangeable products. The first interchangeable biosimilar was Mylan’s Semglee (insulin glargine-yfgn) followed by Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). Interchangeable biosimilar products may be substituted at the pharmacy level for their reference products without prescriber intervention, much as generic drugs may be substituted at the pharmacy level for reference-listed drugs.

 

FDA is also seeing an “increasing uptake of this program in oncology,” added Corrigan-Curay. She added that while there is more uptake of the program in the oncology space, adoption is less prevalent in other treatment areas.

 

Read more about the update here. 

 

 
ASBM’s Madelaine Feldman Testifies at House Oversight Committee

 

On November 17th, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR testified at a public hearing of the Congressional Oversight Committee. Entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, the hearing examined the role of PBMs in contributing to higher drug prices. From Dr. Feldman’s testimony:

 

The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…

 

High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

 

Read more about the Oversight Committee hearing here.
Read Dr. Feldman’s full testimony here. 

 

 
Gewanter Named President-Elect of Medical Society of Virginia

 

Past ASBM Chairman Harry Gewanter, MD, MACR was recently named to the Board of Directors of the Medical Society of Virginia as President-elect.

The nomination was made at the society’s 2021 House of Delegates meeting.

Dr. Gewanter will assume the MSV presidency for a one-year term beginning at the MSV’s next annual meeting in October 2022.

 

Dr. Gewanter served as ASBM’s Chairman from 2014-2017 and continues to serve as a member of ASBM’s International Advisory Board. While ASBM chair, he provided valuable testimony to many state legislatures as they implemented biosimilar substitution legislation.

 

He is a graduate of Duke University and received his medical training at Wayne State University. He conducted his pediatric internship and residency at the University of Rochester/Strong Memorial Hospital. He has practiced in Richmond, Virginia since 1983. After more than three decades, Dr. Gewanter decided to retire from clinical practice to focus his efforts advocating for systemic change for people with disabilities. He is especially passionate on issues affecting children and youth with special health care needs.
Read the MSV’s announcement here.

 
UPCOMING ASBM EVENTS

 

16th Biosimilars Congregation 2021

Virtual – December 9, 2021

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

74th INN Consultation

Geneva, Switzerland – April 5-8, 2022

 

OSU College of Pharmacy Releases Second ASBM-Authored Biosimilars Course

January 3, 2022

The Ohio State University College of Pharmacy is now offering a second 1-hour Continuing Education (CE) course presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.

The course is entitled “Biosimilar Substitution and Interchangeability”, and discusses how biosimilars are substituted at the pharmacy level in the U.S., and contrasts U.S. practices with those in other countries. The course also  examines patient and physician concerns with non-medical switching, and explains the U.S.-specific concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.

The course is the second in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.

View the latest OSU CE course, “Biosimilar Substitution and Interchangeability”, here. (registration required). 

View the first OSU CE Course, Biologics and Biosimilars: and Introduction, here (registration required). 

Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here. 

OSU College of Pharmacy Releases Second ASBM-Authored Biosimilars Course

January 3, 2022

The Ohio State University College of Pharmacy is now offering a second 1-hour Continuing Education (CE) course presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.

The course is entitled “Biosimilar Substitution and Interchangeability”, and discusses how biosimilars are substituted at the pharmacy level in the U.S., and contrasts U.S. practices with those in other countries. The course also  examines patient and physician concerns with non-medical switching, and explains the U.S.-specific concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.

The course is the second in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.

View the latest OSU CE course, “Biosimilar Substitution and Interchangeability”, here. (registration required). 

View the first OSU CE Course, Biologics and Biosimilars: and Introduction, here (registration required). 

Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here. 

December 2021 Newsletter

January 3, 2022

ASBM Letter to Congress: Paying Physicians to Prescribe Government-Preferred Biosimilars Undermines Patient-Physician Relationship

 

On December 2nd, ASBM sent a letter to House leaders reiterating our opposition to a proposal that would undermine the patient-physician relationship and distort the making of treatment decisions. The U.S. House of Representatives Committee on Rules has released new language for H.R. 5376 containing a provision that would pay physicians a 33% bonus for prescribing their patient the government-preferred biosimilar.

 

The bill calls for a “temporary increase in Medicare Part B payments for certain biosimilars,” that would increase the reimbursement to physicians from 6% above average sale price (ASP) to 8%- if they prescribe the biosimilar.

 

Biosimilars have already achieved significant US market share, around 80% for filgrastim biosimilars, 70% for trastuzumab and bevacizumab biosimilars, and 55% for rituximab biosimilars. As more become available, the increased competition has driven down prices of both biosimilars and innovator biologics.

 

Despite these successes, supporters of artificially incentivizing biosimilar uptake have continued to insert this provision into several bills in recent years. From the letter:

 

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally.

 

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies.

 

We also firmly believe this proposal is unnecessary, misguided, and potentially harmful. Instead, all products should continue to compete on a level playing field. Advantaging one manufacturer’s product over another not only distorts the treatment-decision making process and undermines the physician-patient relationship, but also undermines the competition-based policies that are currently lowering prices and expanding patient access.

 

Read ASBM’s full letter here.

Read the current text of H.R. 5376 here.

 

 
ASBM Presents at 16th Biosimilars Congregation

 

On December 9th, ASBM participated in the 16th Biosimilar Congregation, which focused on the Indian biosimilars market. By 2030, India is expected to become the sixth-largest market for pharmaceuticals, and has already firmly established itself in the global biopharmaceutical market. Many Indian pharmaceutical companies are preparing to step into the global biosimilars market.

 

ASBM was represented at the conference by Advisory Board Chair Philip Schneider, who moderated a panel on Market Access. The panel, comprised largely of representatives from Indian pharmaceutical companies, examined key challenges to gaining market access and sought to identify best practices for successfully entering tomorrow’s biosimilar market.

 

Topics discussed included current trends in biosimilar markets, the importance of sustainable pricing and reimbursement practices, ethical concerns, and strategies for overcoming market barriers.

 

A major takeaway from the discussions was that buidling confidence among physicians and patients was critical to success. To that end, panelists were strongly supportive of providing data demonstrating safety and efficacy of Indian biosimilars, including studies which showed patients may switch safely between originator products and biosimilars.

 

Learn more about the 16th Biosimilars Congregation here.

 

 
OSU College of Pharmacy Releases Second ASBM-Authored Biosimilars Course

 

The Ohio State University College of Pharmacy is now offering a second 1-hour Continuing Education (CE) course presented by OSU professor and ASBM Advisory Board Chair Philip Schneider, FASHP, FFIP.

 

The course is entitled “Biosimilar Substitution and Interchangeability”, and discusses how biosimilars are substituted at the pharmacy level in the U.S., and contrasts U.S. practices with those in other countries. The course also  examines patient and physician concerns with non-medical switching, and explains the U.S.-specific concept of interchangeability. The course is ACPE accredited and available to pharmacists nationwide.

 

The course is the second in a series on biosimilars presented by the College of Pharmacy’s Office of Continuing Professional Development. Future course entries will examine topics including biologic pharmacovigilance and nomenclature, physician and patient perspectives on biosimilars, and the biosimilars market.

 

View the latest OSU CE course, “Biosimilar Substitution and Interchangeability”, here. (registration required). 

 

View the first OSU CE Course, Biologics and Biosimilars: and Introduction, here (registration required). 

 

Visit the OSU College of Pharmacy’s Office of Continuing Professional Development here. 

 

 
FDA Approves Second Biosimilar Insulin

 

On December 17th, the FDA announced that it had approved its second biosimilar insulin product, Rezvoglar (insulin glargine-aglr). Rexvoglar is manufactured by Eli Lilly and is a biosimilar to Lantus (insulin glargine).

 

 

Like Lantus, Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

 

It is the 32nd biosimilar product approved in the U.S.

 

Learn more about the approval here. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

 

CMS Rescinds “Most Favored Nation” Model for Medicare Part B

 

On December 29th, the Centers for Medicare and Medicaid Services (CMS) published a final rule rescinding the Most Favored Nation (MFN) Model interim final rule which originally appeared in the November 27, 2020 Federal Register.
The MFN Model would have established a 7-year system by which Medicare would pay for certain Medicare Part B single-source drugs and biologicals (including biosimilars) under section 1115A of the Social Security Act. The MFN Model would have reduced 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 MFN Model was scheduled to take effect January 1, 2021 but was not implemented following four lawsuits and a nationwide preliminary injunction. Opposition to the MFN rule was broad and came from many quarters including physician societies, patient advocacy organizations, the pharmaceutical industry, hospital associations, and others.

 

From the December 29, 2021 Federal Register entry:

“After considering the comments on our proposal [to rescind the MFN Model}, we are finalizing our proposal as proposed. In this final rule, we rescind the November 2020 MFN Model interim final rule and remove the associated regulatory text at 42 CFR part 513.

 

The withdrawal of the MFN Model is effective 60 days after the final rule’s publication, on February 28th, 2022.

 

Read the final rule here. 

 

 
UPCOMING ASBM EVENTS

 

ASCO-GI Meeting 2022

San Francisco, California – Janurary 20-22, 2022

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

74th INN Consultation

Geneva, Switzerland – April 5-8, 2022

 

DIA Global Annual Meeting 2021

Chicago, Illinois – June 19-23, 2022

ASBM Featured in WHO Executive Summary of 73rd INN

December 12, 2021

The World Health Organization recently published the Executive Summary of its 73rd Consultation on International Nonproprietary Names, at which ASBM presented on October 19, 2021.

From the Executive Summary:

Objections to the use of distinct non-proprietary names for biosimilars quote that they may imply inferiority, that they may undermine confidence in their use and may hinder uptake. However, in the USA where biologics and biosimilars are distinguished with 4-letter suffix, this is not the case. In a new ASBM survey of 403 physicians who prescribe biologics in practice, a good majority did not think the FDA suffix implies inferiority while >90% expressed confidence in the safety and efficacy of biosimilars.

Notably, US physicians were more comfortable prescribing biosimilars to naïve patients than their EU counterparts. It is important to note also that in the USA all biosimilars and reference products will eventually have suffixes in the product name.

As to whether the FDA suffixes had held back adoption of biosimilars, it was shown that filgrastim biosimilars had achieved an 80% share of the market, and that various MAb biosimilars have a good share of the US market and which is expected to be >50% within 2 years, with price and not nomenclature appearing to be the predominant factor in increasing biosimilar uptake.

In summary, the ASBM concluded that even in advanced countries there is inadequate identification using the brand name only and using distinguishable non-proprietary naming will strengthen pharmacovigilance programmes. A concern that distinguishable naming via use of a suffix would imply inferiority and hurt uptake, does not appear to be borne out and the ASBM will continue to work with regulators on this issue.

…The Chair noted that there was a perception in some circles that the INN Programme’s BQ proposal was closed, whereas essentially it is on hold, and requested the ASBM to continue the debate not only with the INN group but also to write to the Executive Board of the WHO.

Read the full Executive Summary here. 

ASBM Chairman Moderates Webinar at DDNC Policy Conference

December 8, 2021

On November 15th, ASBM Chairman Ralph McKibbin, MD moderated a panel discussion at the Digestive Disease National Coalition’s Fall policy-setting forum.

The Fall Forum ran from November 15th-19th and gathered together policymakers, caregivers, and patients to discuss the latest developments in digestive disease policy. The webinar included an overview of DDNC funding priorities, presentations from DDNC member organizations, and an informational session on the Safe Step Act.

The Safe Step Act is a bill which would regulate the utilization-management technique known as “step therapy”- where patients are required by insurers or pharmacy benefit managers to deny patients access to the medicines selected by their physicians, until they have failed one or more lower-cost treatments.  Alaska Senator Lisa Murkowski, lead sponsor of the bill, presented.
A major topic of discussion at the five-day conference was a recent paper on step therapy entitled “Variation In Use And Content Of Prescription Drug Step Therapy Protocols, Within And Across Health Plans”. From the paper’s abstract:
Insurers limit the use of certain prescription drugs by requiring step therapy—that is, by allowing access only after alternatives have been tried and have failed. Using data from seventeen of the largest US commercial health plans, we examined step therapy protocols that determined patients’ eligibility for specialty drugs and identified ten diseases that are often subject to that requirement.
The authors’ analysis found that that 55.6 percent of step therapy protocols were more stringent than the corresponding clinical guidelines, and that these protocols varied widely both within and between. The authors observed that:
“These findings raise questions about potentially overly restrictive step therapy protocols, as well as concerns that variability across health plans makes protocols onerous for patients and practitioners alike. The findings thus suggest the need for state and federal legislation.”

ASBM Chairman Moderates Webinar at DDNC Policy Conference

December 8, 2021

On November 15th, ASBM Chairman Ralph McKibbin, MD moderated a panel discussion at the Digestive Disease National Coalition’s Fall policy-setting forum.

The Fall Forum ran from November 15th-19th and gathered together policymakers, caregivers, and patients to discuss the latest developments in digestive disease policy. The webinar included an overview of DDNC funding priorities, presentations from DDNC member organizations, and an informational session on the Safe Step Act.

The Safe Step Act is a bill which would regulate the utilization-management technique known as “step therapy”- where patients are required by insurers or pharmacy benefit managers to deny patients access to the medicines selected by their physicians, until they have failed one or more lower-cost treatments.  Alaska Senator Lisa Murkowski, lead sponsor of the bill, presented.
A major topic of discussion at the five-day conference was a recent paper on step therapy entitled “Variation In Use And Content Of Prescription Drug Step Therapy Protocols, Within And Across Health Plans”. From the paper’s abstract:
Insurers limit the use of certain prescription drugs by requiring step therapy—that is, by allowing access only after alternatives have been tried and have failed. Using data from seventeen of the largest US commercial health plans, we examined step therapy protocols that determined patients’ eligibility for specialty drugs and identified ten diseases that are often subject to that requirement.
The authors’ analysis found that that 55.6 percent of step therapy protocols were more stringent than the corresponding clinical guidelines, and that these protocols varied widely both within and between. The authors observed that:
“These findings raise questions about potentially overly restrictive step therapy protocols, as well as concerns that variability across health plans makes protocols onerous for patients and practitioners alike. The findings thus suggest the need for state and federal legislation.”
logo logo logo