Search Results for "harmonization"

ASBM Presents on Need for International Harmonization of Biologic Nomenclature at WHO 70th INN Consultation

April 23, 2020

On April 21st, ASBM presented to the World Health Organization’s (WHO’s) 70th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fourteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online for the first time.

In June 2020, the World Health Organization released an Executive Summary of the 70th INN Consultation. From the Executive Summary:

The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA.

The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own systems but would have used a WHO system if WHO had moved ahead with the BQ.

The most common objection to a distinct suffix is that it implies biosimilars are inferior products and the US Federal Trade Commission (FTC) has raised the possibility that the current FDA naming system deters prescribers from using biosimilars, and impedes competition and price reduction. Some state pharmacists also feel that way. This false impression of inferiority has prompted two recent high-level meetings in Washington DC. The first was a joint FDA/FTC workshop, to address accusations that there had been disinformation to undermine physicians’ confidence in biosimilars, to address a perceived need for education on biosimilar safety, and a need to address patent regulation that has held back the use of biosimilars in the USA.

However, market share data suggest little, if any, lack of confidence in biosimilar use; for example, the market share of biosimilar ZARXIO (filgrastim-sndz) surpasses that of the reference product NEUPOGEN (filgrastim) in both the EU and the USA. So, the argument that the suffix creates a lack of confidence is false.

View ASBM’s presentation to the WHO INN Committee here:

Part 1
Part 2

Read the Executive Summary of the 70th INN Consultation here. 

 

Read more about ASBM’s work on the issue of biologic naming here. 

 

 

ASBM Presents to WHO, Urging International Harmonization of Biologic Nomenclature

October 28, 2019

On October 22nd, ASBM presented at the World Health Organization’s (WHO’s) 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the thirteenth INN Consultation at which ASBM has presented. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme,  the Executive Summary from the 68th INN Consultation – held on April 2, 2019 and in which ASBM also participated – may be viewed here.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

ASBM Meets with Health Canada, FDA, WHO on Biologic Nomenclature Harmonization

March 7, 2019

On March 6th in Ottawa, Ontario, ASBM hosted the third in a series of meetings between health regulators and other stakeholders from around the globe to discuss the international harmonization of biologic nomenclature and the importance of distinguishable naming. Representatives from Health Canada, the FDA, and WHO participated. 

march6-reilly

The meeting began with opening remarks by ASBM Executive Director Michael Reilly thanking the participants. He emphasized the shared support for global harmonization and for WHO leadership in that effort. Participants then introduced themselves; they included:

  • Michael Reilly, Executive Director, ASBM
  • Philip Schneider, MS FASHP FFIP; Advisory Board Chair, ASBM
  • Madelaine Feldman, MD, FACR; Chair, ASBM
  • Rafaella Balocco Mattavelli, INN Programme Lead, World Health Organization
  • Anthony Ridgway, Health Canada
  • Stephanie Hardy, Health Canada
  • Andrew Spiegel, Global Colon Cancer Association
  • Gail Attara, Gastrointestinal Society
  • Ganive Bhinder, Better Pharmacare Coalition
  • Laurie Proulx, Canadian Arthritis Patient Alliance
  • Jaymee Maaghop, Canadian Cancer Survivor Network
  • Christine Janus, International Association of Dermatology Patient Organizations
  • Eric Lamoreaux, Canadian Patient Safety Institute
  • Maureen Smith, Canadian Organization for Rare Disorders
  • Angie Hamson, Patients for Patient Safety Canada
  • Karen J. Kieley, Royal College of Physicians and Surgeons
  • Caroline Herzberg, Canadian Dermatology Association

ASBM Advisory Board Chair Philip Schneider then presented a recap of the first two meetings, which were held in April and July of last year in Washington, DC. In these meetings, a strong consensus emerged on the importance of distinct naming and in favor of international harmonization. Health Canada in particular was a leading advocate of both.

Schneider then recounted several developments in the naming discussion that have occurred since the July meeting. First was the publication of the Scientific American whitepaper based on the April meeting, which may be read here. Second was ASBM’s participation in the 67th INN Consultation on October 13, 2018. Third was the publication of an article in the GaBI Journal emphasizing the benefits of the WHO’s Biological Qualifier (BQ) proposal for countries in the Middle East and North Africa region without robust pharmacovigilance systems of their own. The BQ would assign a 4-letter suffix to all biologics and biosimilars sharing an INN.

Dr. Schneider also shared objections to distinct naming- in particular to the WHO’s BQ proposal- that have been raised over the years, including that the system would be redundant, or might impede access, and proceeded to address them.  For example, while advanced countries in Europe have robust pharmacovigilance systems, many developing nations do not. The Ministry of Health in the United Arab Emirates, Schneider noted, has expressed its support for the WHO’s BQ proposal, as have physicians in Latin America, 94% of whom consider it helpful in ensuring their patients receive the correct medicine.

Finally, Dr. Schneider discussed the surprising announcement by Health Canada on February 14th regarding their biologic naming policy. Despite their previous support for distinct naming and harmonization, their policy will in fact use shared nonproprietary names for multiple products, in conjunction with the brand name, and will rely heavily on the use of the Drug Identification Number (DIN). The DIN is used chiefly by Canadian pharmacists to track safety and efficacy issues. This policy is based on the results of a consultation in which a disproportionate number (62%) of the respondents were pharmacists and pharmacy organizations.
Pie chart of submissions by stakeholder group. Text equivalent follows.

As Dr. Schneider observed, this consultation and the resulting policy fails to adequately consider not only the perspectives of patients, but that of physicians.

physsupportFor example, in a 2017 survey of 403 Canadian prescribers of biologics, ASBM found:

  • 68% of physicians supported Health Canada assigning unique, distinct names to all biologics and biosimilars. 

  • Only 1% of these physicians said they identify the medicine in the patient record using the DIN.
     
  • 20% record only the product’s non-proprietary name in the patient record, not the brand name. This can result in inadvertent or inappropriate substitutions, as well as the physician not being aware of which among a number of products the patient will be dispensed at the pharmacy. 

  • When reporting adverse events, only 4% of physicians use the DIN. 

  • When reporting adverse events, 26% record only the product’s non-proprietary name. This can result in misattribution of an adverse event to the wrong product. 

  • Only 23% of physicians consistently record batch/lot number when reporting adverse events.
Given physician support for distinct naming and their documented prescribing practices, ASBM’s analysis concluded that Health Canada’s announced policy does not adequately address the pharmacovigilance challenges of biologics and biosimilar medicines.
hc-patients
One of the reasons cited by Health Canada for the decision was lack of implementation by the WHO of an international naming standard, such as the BQ proposal. The FDA implemented a similar system in 2015 and had been in talks with Canada to harmonize nomenclature.

FDA official Lubna Merchant, who attended the first two meetings, joined the meeting via teleconference.

fda-screen
Ms. Merchant expressed regret that FDA and Health Canada were unable to come to an agreement to harmonize their nomenclature; and emphasized FDA’s continuing commitment to distinct naming as a tool to ensure accurate tracking of biologic medicines and their effects.
patient-hanson
In response to Health Canada’s announcement, Patient advocate Angie Hamson of Patients for Patient Safety Canada highlighted her concern that minor differences between biologic medicines from different manufacturers could produce different effects, and that the use of shared nonproprietary names could make product identification harder for patients.
meeting-wide
Despite Health Canada’s decision not to harmonize with the FDA suffix system, the regulator expressed its continued support for WHO leadership on establishing a global nomenclature standard, and the potential of harmonizing with such a standard if and when it is implemented.
march6-ridgway
Dr. Rafaella Balocco, WHO INN Programme lead, provided an update on the discussion of the international harmonization discussion from the WHO perspective, and assured the participants that she would convey the proceedings back to the WHO upon her return to Geneva.
march6-whocanDr. Balocco also expressed hope that Canada’s decision would further underscore the urgent need for the WHO to take a leadership role on biologic naming and implement the BQ standard.

balocco-patient

Mr. Reilly closed the meeting by acknowledging that despite Health Canada’s decision not to pursue a suffix-based system, there still remains a common desire for international harmonization among many regulators worldwide, including Health Canada and FDA; and all parties agreed to continue work toward that goal by offering support to the WHO’s efforts.
group-fda
View ASBM’s presentation here.

ASBM Hosts Forum on International Naming Harmonization

April 12, 2018

On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines.  Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and what steps might be taken to operationalize a global naming scheme.

Springer-Nature-Luncheon-The Source-Washington-DC
Health Canada’s Anthony Ridgway, left, and ASBM President Doug Badger, right, listen as ASBM Executive Director Michael Reilly discusses the value of internationally-harmonized biologic naming. 

The Alliance for Safe Biologic Medicines (ASBM), in partnership with Scientific American, hosted the event.  Brady Huggett, Business Editor of Nature Biotechnology, a Scientific American publication, moderated the event.

Since their introduction into global healthcare markets a decade ago, biosimilars have greatly expanded treatment options. For example, to date, nine biosimilars have received FDA approval in U.S. with 240 in the development pipeline; in Europe 28 biosimilars have been approved in the past 10 years.

However, global harmonization of biologic naming has not yet been achieved—a situation that may impede pharmacovigilance, patient safety, prescriber clarity and even uptake of these medicines. This is because the regulatory agencies in different countries have varied in their approaches to the naming biologics and biosimilars.

At the meeting, it was clear that participants agreed that distinguishable names and a harmonization of naming conventions across regions for all biologics (innovator and biosimilar) would ultimately improve patient safety and access.

img_1203
Andrew Spiegel of the Global Colon Cancer Association emphasizes the value of distinguishable naming for patients worldwide. 

“Through clarity, you get safety,” stated Peter Pitts, President of the Centers for Medicine in the Public Interest and former Associate Commissioner for External Relations at the FDA.

Springer-Nature-Luncheon-The Source-Washington-DC
Former FDA Associate Commissioner Peter Pitts comments on the value of unique naming for all biologics. 

ASBM intends to present the perspectives shared at this meeting to the World Health Organization (WHO) at its appearance May 1st at the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances.  In addition, Scientific American will write a white paper on the proceedings to be published in Nature Biotechnology.

ASBM Executive Director Michael Reilly expressed hope that the conversation will continue and broaden to include other regulators such as the WHO, Australia’s Therapeutic Goods Administration (TGA) and Brazilian Health Regulatory Agency ANVISA: “It is [ASBM’s] intent that this forum not be a stand-alone event but rather the first in a series of meetings and part of the ongoing global conversation on this issue.”

 

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ASBM Hosts Forum on International Naming Harmonization

April 12, 2018

On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines.  Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and what steps might be taken to operationalize a global naming scheme.

Springer-Nature-Luncheon-The Source-Washington-DC
Health Canada’s Anthony Ridgway, left, and ASBM President Doug Badger, right, listen as ASBM Executive Director Michael Reilly discusses the value of internationally-harmonized biologic naming. 

The Alliance for Safe Biologic Medicines (ASBM), in partnership with Scientific American, hosted the event.  Brady Huggett, Business Editor of Nature Biotechnology, a Scientific American publication, moderated the event.

Since their introduction into global healthcare markets a decade ago, biosimilars have greatly expanded treatment options. For example, to date, nine biosimilars have received FDA approval in U.S. with 240 in the development pipeline; in Europe 28 biosimilars have been approved in the past 10 years.

However, global harmonization of biologic naming has not yet been achieved—a situation that may impede pharmacovigilance, patient safety, prescriber clarity and even uptake of these medicines. This is because the regulatory agencies in different countries have varied in their approaches to the naming biologics and biosimilars.

At the meeting, it was clear that participants agreed that distinguishable names and a harmonization of naming conventions across regions for all biologics (innovator and biosimilar) would ultimately improve patient safety and access.

img_1203
Andrew Spiegel of the Global Colon Cancer Association emphasizes the value of distinguishable naming for patients worldwide. 

“Through clarity, you get safety,” stated Peter Pitts, President of the Centers for Medicine in the Public Interest and former Associate Commissioner for External Relations at the FDA.

Springer-Nature-Luncheon-The Source-Washington-DC
Former FDA Associate Commissioner Peter Pitts comments on the value of unique naming for all biologics. 

ASBM intends to present the perspectives shared at this meeting to the World Health Organization (WHO) at its appearance May 1st at the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances.  In addition, Scientific American will write a white paper on the proceedings to be published in Nature Biotechnology.

ASBM Executive Director Michael Reilly expressed hope that the conversation will continue and broaden to include other regulators such as the WHO, Australia’s Therapeutic Goods Administration (TGA) and Brazilian Health Regulatory Agency ANVISA: “It is [ASBM’s] intent that this forum not be a stand-alone event but rather the first in a series of meetings and part of the ongoing global conversation on this issue.”

 

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March 2023 Newsletter

April 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment
On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022. The IRA grants new authority for CMS to negotiate “maximum fair prices” (MFPs) for certain high expenditure, single source drugs and biological products. From the memo:

 

This initial guidance describes how CMS intends to implement the Negotiation Program for initial price applicability year 2026 (January 1, 2026 to December 31, 2026), and specifies the requirements that will be applicable to manufacturers of Medicare Part D drugs that are selected for negotiation and the procedures that may be applicable to manufacturers of Medicare Part D drugs, Medicare Part D plans (both Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug Plans (MA-PDs)), and providers and suppliers (including retail pharmacies) that furnish Medicare Part D drugs.

 

The memo notes that CMS is not following the typical notice-and-comment requirements of the Administrative Procedure Act or the Medicare statute, citing both legislative direction and its own assessment: “CMS finds that notice and public procedure on this guidance would be impracticable, unnecessary, and contrary to the public interest”.

 

While some of the guidance is being issued as final, the announcement solicits offers just 30 days for concerned parties to comment on other portions of the guidance:
Please send comments pertaining to this memorandum to IRARebateandNegotiation@cms.hhs.gov with the following subject line “Medicare Drug Price Negotiation Program Guidance.” Comments received by April 14, 2023 will be considered.

 

“To undertake such a major change to the Medicare program outside of the notice-and-comment period is highly unusual and runs counter to long-established procedures”, says ASBM Executive Director Michael Reilly, who served for 6 years in the Office of the Secretary at the Department of Health and Human Services (HHS) as Medicare Part D was being developed and implemented. “Unfortunately, rushed policy made absent stakeholder input rarely results in good policy”.

 

Read the CMS Guidance Memo here. 
Send Comments on the Guidance to CMS here.

 

 

 
ASBM Presents at WHO 76th INN Consultation

 

On March 28th, ASBM participated in the World Health Organization’s 76th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the twentieth INN Consultation in which ASBM has participated.

 

ASBM was represented at the session 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.

 

The recently-published Executive Summary from the 75th INN Consultation, at which ASBM presented in October 2022, summarizes ASBM’s position regarding the value of distinct biologic nomenclature:

 

One significant challenge to efficient global cooperation is the lack of harmonization. Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Indeed, surveys show that there remains a clear need for harmonization of distinguishable names with only two-thirds of ADR reports recording the brand name of the biologic, and even fewer recording the non-proprietary name. Other surveys show that only a small proportion of physicians record the non-proprietary name and extremely few use an officially recommended drug code number.

 

In conclusion, the ASBM urged the WHO to make a voluntary distinct naming standard available to facilitate international cooperation and harmonization. This will help speed approval, increasing access to biosimilars while promoting safety and building confidence through strong post-market monitoring.

 

Read the WHO’s summary of the 75th INN Consultation here.

 

 
Biden Administration to Develop Framework to Implement “March-In Rights” 

 

On March 21st, the U.S. Department of Health and Human Services (HHS), with the U.S. Department of Commerce, announced the formation of an working group to develop an implementation framework for the government to exercise ‘march-in” rights as a tool to lower drug prices.

 

The announcement indicates a “whole-of-government approach” will be used to review its march-in authority as laid out in the Bayh-Dole Act, which promotes commercialization of research results, maximizes the potential for federally-funded technologies to become products, and serves the broader interest of the American public. From the press release:
The Interagency Working Group for Bayh-Dole will develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies’ assessments.

 

“The Biden-Harris Administration is committed to increasing access to health care and lowering costs. And march-in authority is a powerful tool designed to ensure that the benefits of the American taxpayer’s investment in research and development are reasonably accessible to the public,” said HHS Secretary Xavier Becerra. “We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward.”

 

Under the Bayh-Dole Act, adopted in 1980, the government can promote the commercialization and public availability of even partially government-funded inventions. But when it comes to using the law to drop the price of a drug under patent protection, the move has never been successful.

 

In another letter dated the same day, HHS, which oversees the National Institutes of Health (NIH) declined to use “march-in” rights to lower the price of Astellas’ and Pfizer’s prostate cancer drug Xtandi (enzalutamide).

 

From the letter:
“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

 

Read the press release here. 
Read the letter declining to exercise march-in rights in the case of Xtandi(enzalutamide) here.

 

 

 
Upcoming ASBM/GaBI Webinar to Focus on IRA’s Price Negotiation Provisions

 

On May 3rd, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences that may result from the implementation of IRA provisions regarding biologic and biosimilar medicines.

 

The first webinar, tentatively scheduled for May 3rd, will focus on the IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid to negotiate prices of certain costly drugs, including many biologic medicines. Webinar presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and on the practice of healthcare professionals including physicians and pharmacists.

 

More information will be available in the coming weeks.

 

 

 
ASBM Chair Advocates for PBM Reform on Capitol Hill

 

On March 5th-6th, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF participated in the 33rd annual Digestive Disease National Coalition public policy forum in Washington, DC March 5th and 6th.

 

The advocacy conference brought together patient advocates, health care providers, and industry representatives from the major national voluntary and professional societies concerned with digestive diseases. This year’s theme was “Improving Patient Care.”

 

Live panelists included Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition at the National Institute for Diabetes, Digestive and Kidney Diseases and Brenda Rodriguez, Senior Engagement Officer at the Patient-Centered Outcomes Research Institute. Both highlighted the need for focusing on patient outcomes in this age of rising inflation and medication costs.

ASBM Chairman Ralph McKibbin MD; DDNC President Carrol Koscheski; and Brad Conway, VP of Legislative Affairs and Advocacy for the American College of Gastroenterology were among the physicians who met with lawmakers on PBM reform and other issues.

ASBM Chairman Ralph McKibbin MD; DDNC President Carrol Koscheski; and Brad Conway, VP of Legislative Affairs and Advocacy for the American College of Gastroenterology were among the physicians who met with lawmakers on PBM reform and other issues.

 

Dr. McKibbin, along with DDNC leadership, met with Representative Buddy Carter of Georgia – a champion for pharmacy benefit manager (PBM) reform – to discuss the need legislation in this area. Rep. Carter is a pharmacist who ran a chain of local pharmacies prior to becoming a congressional representative and is well informed on the issues. He has produced an educational booklet on the subject entitled “Pulling Back the Curtain on PBMs: A Path Towards Affordable Prescription Drugs”.

 

 

 
FDA Approves High-Concentration Adalimumab Biosimilar

 

On March 21st, the FDA approved a citrate-free, high-concentration formulation (HCF) of the adalimumab biosimilar Hyrimoz (adalimumab-adaz) manufactured by Sandoz.

 

The injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

 

Sandoz intends to launch the biosimilar in the United States on July 1, 2023.

The first biosimilar for Humira, Amejevita (adalimumab-atto) was launched in February by Amgen and is expected to be the only adalimumab biosimilar on the market until July, although several more are expected to launch this year.
Read about the approval here.
 
FDA Releases New Biosimilars Education Materials for Patients

 

On March 21st, the U.S. Food and Drug Administration (FDA) released three new educational resources about biosimilars, targeted at patients:

 

Biosimilars: What Patients Need to Know

Biosimilars: What Patients With Diabetes Need to Know

Biosimilar Basics Infographic

 

The materials answer basic questions that patients might have about biologic medicines and biosimilars, including:

  • What are biologic medications?
  • How are they different from other types of medications?
  • What are interchangeable biosimilars?
  • Why aren’t biosimilars identical to the original biologics?
  • Why would a patient switch from an original biologic to a biosimilar?

For more information about biosimilars and additional resources for patients, visit the FDA’s “Biosimilar Basics for Patients” educational site here.

 

 
UPCOMING EVENTS

 

ASBM/GaBI IRA Webinar

May 3, 2023

Digestive Disease Week 2023
Chicago, IL – May 6-9

 

ASCO 2023

Chicago, IL – June 2-6, 2023

 

DIA Global Annual Meeting

Boston, MA – June 25-29, 2023

 

ASBM Presents at WHO 76th INN Consultation

March 30, 2023

On March 28th, ASBM participated in the World Health Organization’s 76th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the twentieth INN Consultation in which ASBM has participated.

ASBM was represented at the session 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.

The recently-published Executive Summary from the 75th INN Consultation, at which ASBM presented in October 2022, summarizes ASBM’s position regarding the value of distinct biologic nomenclature:

One significant challenge to efficient global cooperation is the lack of harmonization. Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Indeed, surveys show that there remains a clear need for harmonization of distinguishable names with only two-thirds of ADR reports recording the brand name of the biologic, and even fewer recording the non-proprietary name. Other surveys show that only a small proportion of physicians record the non-proprietary name and extremely few use an officially recommended drug code number.

In conclusion, the ASBM urged the WHO to make a voluntary distinct naming standard available to facilitate international cooperation and harmonization. This will help speed approval, increasing access to biosimilars while promoting safety and building confidence through strong post-market monitoring.

Read the WHO’s summary of the 75th INN Consultation here.

October 2021 Newsletter

November 8, 2021

House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship

 

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. In July, ASBM sent a letter to Congress opposing this proposal’s inclusion in H.R. 2815. 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.

 

 

 
Ohio State University College of Pharmacy To Launch Online CE Program

 

In the coming weeks, the Ohio State University College of Pharmacy will launch a new online Continuing Education (CE) program. Among the first offerings in this program will be a series of presentations related to biologics and biosimilars, sponsored by ASBM. Topics will include a primer on biologics and biosimilars, substitution of biologics and biosimilars, issues with non-medical switching, pharmacovigilance programs and the importance of distinguishable non-proprietary names, the biosimilars market, physician perspectives on biologics and biosimilars, and patient perspectives.

 

The new CE platform being used at OSU will be available nationwide. With the rapid increase in the number of biologic and biosimilars reaching the market and the advent of interchangeable biosimilars, the need for educational programming for pharmacists is significant.

 

This program will equip pharmacists with the knowledge needed to play an important role in helping to navigate the increasingly complex challenges associated with the safe and effective use of biologics and the responsible use of limited healthcare resources.

 

 
ASBM Presents at World Drug Safety Congress USA 2021

 

On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.

 

Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.

 

Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics in Adverse Drug Reaction (ADR) reports and self-reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.

 

Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.

 

View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.

 

 
ASBM Presents at WHO’s 73rd INN Consultation

 

On October 19th, ASBM participated in the World Health Organization’s 73rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the seventeenth INN Consultation in which ASBM has participated.

 

ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
While the discussions at the INN Consultation are confidential pending publication of an Executive Summary by the INN Programme, the Executive Summary from the 72nd INN Consultation – held April 13th, 2021 and in which ASBM also participated – may be viewed here. From that report:

 

“Many published reports, including ASBM’s own surveys of prescribers over several years, show a clear lack of identification of the brand name in ADR reports, especially in the EU in which brand name reporting became a mandatory requirement in 2012.”

 

“ASBM highlighted that reporting on brand names in ADR reports continues to be inadequate despite widespread recognition of its importance. WHO has identified a lack of a naming standard as a regulatory challenge that undermines the strong pharmacovigilance needed for biologics and biosimilars, and ASBM underlined that the WHO has the ability and the duty to make a global standard available to address this global pharmacovigilance need.”

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, including holding a series of meetings with FDA, Health Canada, and the WHO on the subject.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

 
Michael Reilly Op-ed: Forced Biosimilar Switching Would Put Ontario on Wrong Track

 

On October 5, an op-ed by ASBM Executive Director Michael Reilly ran in several Ontario papers including The Hamilton Spectator, the Welland Tribune, the St. Catharine’s Standard, and the Niagara Falls Review.

 

The op-ed highlights the concerns with forced-biosimilar-substitution policies

 

A survey of 403 Canadian specialists found that 73% are uncomfortable with a third party initiating a biologic switch for non-medical reasons (typically the cost), as occurs in the British Columbia and Alberta policies. These findings were affirmed by Quebec’s own government (INESSS) in a May 2020 report which concluded that “Non-medical switching in patients being treated with a reference biologic is generally not accepted by learned societies and the consulted clinicians.”

 

The Canadian Association of Gastroenterology (CAG) released a paper objecting to the B.C. policy; noting that BC Pharmacare’s substitution policy went against the recommendations of 14 gastroenterology societies throughout Canada and Europe. Many patient advocacy organizations also opposed these policies, including the Gastrointestinal Society and Crohn’s and Colitis Canada.

 

“It was a very long, difficult 2 1/2 year journey to find [the originally-prescribed] drug. All other drugs failed,” said one B.C. arthritis patient who was forced to switch. “I am shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs.”

 

The New Brunswick and Quebec announcements cited 15 years of experience with biosimilars in Europe to justify forced switching. However, as the op-ed explains:

 

Automatic substitution of biologics is almost universally prohibited in Europe. In nearly every European country, physicians are free to choose between multiple products, including the originators, and the payer will reimburse them – resulting in both high biosimilar usage and high savings while preserving patient and physician control of treatment decisions.

 

Mr. Reilly recently authored similar op-eds in New Brunswick (English) and Quebec (French).

 

 

Read ASBM’s recent whitepaper “A Critical Review of Substitution Policy for Biosimilars in Canada.” The paper contrasts the forced-substitution policies of some Canadian provinces with the competition-based approaches which have driven biosimilar uptake in Europe and the U.S. 

 

 
FDA Finalizes Guidance on Biosimilar Development

 

In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance.

 

The update added five questions, including:

  • Sponsor responsibilities related to pediatric assessments for proposed biosimilar products
  • The types of information needed to support post-approval manufacturing changes
  • Clarification that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
  • Clarification that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product.
  • An explanation that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).

In addition, several questions were withdrawn, while others underwent minor editorial changes.

 

Learn more about the updated guidance here. 

 

Read the guidance here. 

 
UPCOMING ASBM EVENTS

 

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

 

16th Biosimilars Congregation 2021

Virtual – December 9, 2021

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

 

 

 

October 2021 Newsletter

November 8, 2021

House Bill Would Distort Treatment Decisions, Undermine Physician-Patient Relationship

 

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. In July, ASBM sent a letter to Congress opposing this proposal’s inclusion in H.R. 2815. 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.

 

 

 
Ohio State University College of Pharmacy To Launch Online CE Program

 

In the coming weeks, the Ohio State University College of Pharmacy will launch a new online Continuing Education (CE) program. Among the first offerings in this program will be a series of presentations related to biologics and biosimilars, sponsored by ASBM. Topics will include a primer on biologics and biosimilars, substitution of biologics and biosimilars, issues with non-medical switching, pharmacovigilance programs and the importance of distinguishable non-proprietary names, the biosimilars market, physician perspectives on biologics and biosimilars, and patient perspectives.

 

The new CE platform being used at OSU will be available nationwide. With the rapid increase in the number of biologic and biosimilars reaching the market and the advent of interchangeable biosimilars, the need for educational programming for pharmacists is significant.

 

This program will equip pharmacists with the knowledge needed to play an important role in helping to navigate the increasingly complex challenges associated with the safe and effective use of biologics and the responsible use of limited healthcare resources.

 

 
ASBM Presents at World Drug Safety Congress USA 2021

 

On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.

 

Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.

 

Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics in Adverse Drug Reaction (ADR) reports and self-reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.

 

Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.

 

View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.

 

 
ASBM Presents at WHO’s 73rd INN Consultation

 

On October 19th, ASBM participated in the World Health Organization’s 73rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the seventeenth INN Consultation in which ASBM has participated.

 

ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
While the discussions at the INN Consultation are confidential pending publication of an Executive Summary by the INN Programme, the Executive Summary from the 72nd INN Consultation – held April 13th, 2021 and in which ASBM also participated – may be viewed here. From that report:

 

“Many published reports, including ASBM’s own surveys of prescribers over several years, show a clear lack of identification of the brand name in ADR reports, especially in the EU in which brand name reporting became a mandatory requirement in 2012.”

 

“ASBM highlighted that reporting on brand names in ADR reports continues to be inadequate despite widespread recognition of its importance. WHO has identified a lack of a naming standard as a regulatory challenge that undermines the strong pharmacovigilance needed for biologics and biosimilars, and ASBM underlined that the WHO has the ability and the duty to make a global standard available to address this global pharmacovigilance need.”

 

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, including holding a series of meetings with FDA, Health Canada, and the WHO on the subject.

 

Read more about ASBM’s work with the WHO’s INN Group here. 

 

 

 
Michael Reilly Op-ed: Forced Biosimilar Switching Would Put Ontario on Wrong Track

 

On October 5, an op-ed by ASBM Executive Director Michael Reilly ran in several Ontario papers including The Hamilton Spectator, the Welland Tribune, the St. Catharine’s Standard, and the Niagara Falls Review.

 

The op-ed highlights the concerns with forced-biosimilar-substitution policies

 

A survey of 403 Canadian specialists found that 73% are uncomfortable with a third party initiating a biologic switch for non-medical reasons (typically the cost), as occurs in the British Columbia and Alberta policies. These findings were affirmed by Quebec’s own government (INESSS) in a May 2020 report which concluded that “Non-medical switching in patients being treated with a reference biologic is generally not accepted by learned societies and the consulted clinicians.”

 

The Canadian Association of Gastroenterology (CAG) released a paper objecting to the B.C. policy; noting that BC Pharmacare’s substitution policy went against the recommendations of 14 gastroenterology societies throughout Canada and Europe. Many patient advocacy organizations also opposed these policies, including the Gastrointestinal Society and Crohn’s and Colitis Canada.

 

“It was a very long, difficult 2 1/2 year journey to find [the originally-prescribed] drug. All other drugs failed,” said one B.C. arthritis patient who was forced to switch. “I am shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs.”

 

The New Brunswick and Quebec announcements cited 15 years of experience with biosimilars in Europe to justify forced switching. However, as the op-ed explains:

 

Automatic substitution of biologics is almost universally prohibited in Europe. In nearly every European country, physicians are free to choose between multiple products, including the originators, and the payer will reimburse them – resulting in both high biosimilar usage and high savings while preserving patient and physician control of treatment decisions.

 

Mr. Reilly recently authored similar op-eds in New Brunswick (English) and Quebec (French).

 

 

Read ASBM’s recent whitepaper “A Critical Review of Substitution Policy for Biosimilars in Canada.” The paper contrasts the forced-substitution policies of some Canadian provinces with the competition-based approaches which have driven biosimilar uptake in Europe and the U.S. 

 

 
FDA Finalizes Guidance on Biosimilar Development

 

In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance.

 

The update added five questions, including:

  • Sponsor responsibilities related to pediatric assessments for proposed biosimilar products
  • The types of information needed to support post-approval manufacturing changes
  • Clarification that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
  • Clarification that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product.
  • An explanation that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).

In addition, several questions were withdrawn, while others underwent minor editorial changes.

 

Learn more about the updated guidance here. 

 

Read the guidance here. 

 
UPCOMING ASBM EVENTS

 

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

 

16th Biosimilars Congregation 2021

Virtual – December 9, 2021

 

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

 

 

 

 

ASBM Presents at World Drug Safety Congress USA 2021

November 8, 2021

On October 21st, ASBM’s Philip Schneider participated in the World Drug Safety Congress USA 2021, held in Boston, MA. Dr. Schneider led a panel discussion on improving pharmacovigilance programs globally.

Panelists were in general agreement that there is a greater need for improving the quality of adverse drug event reports, particularly in developed countries.

Improvement of biologic pharmacovigilance systems was the topic of a poster abstract presented by Dr. Schneider at the DIA Global Annual Meeting in June 2021. The poster focused on the challenges in accurately identifying biologics in Adverse Drug Reaction (ADR) reports and self-reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.

Another issue discussed in the panel was the need for global harmonization of pharmacovigilance programs so that everyone can benefit from the learnings from these reports. It was agreed that the WHO, which has proposed a global nomenclature standard, would be the logical agency to take the lead in harmonization efforts.

View a video walkthrough of ASBM’s poster on problems with global pharmacovigilance of biologic medicines here.