Safe Biologics

On August 31st, several ASBM representatives joined Tiffany Westrich-Robertson, CEO of the International Foundation for Autoimmune & Autoinflammatory Diseases, to record an episode of the AI Arthritis Voices 360 podcast. The episode discussed examined policy issues surrounding biosimilars and how these affect patients.

ASBM was represented in the discussion by Executive Director Michael Reilly; Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association (GCCA).

Discussion topics included the basics of biosimilars, how they differ from traditional biological drugs, and how and when they may be substituted. The practice of non-medical switching by third parties is controversial among physicians due to patient-specific differences and a patient’s unique medical history, explained Dr. McKibbin: “Treatment plans are not one size fits all”.

Andrew Spiegel offered his perspective as a patient advocate: “The patient community is excited about biosimilars- but we want these policies to work for patients.”

Mr. Reilly provided an overview of different biosimilar substitution policies worldwide, and emphasized that the most successful biosimilar markets have been those which allowed physician and patient control of treatment decisions: Europe has the most robust and successful biosimilar markets in the world; and in every European country, physicians and patients are free to choose among many products including the originator and several biosimilars-all are reimbursed. This competition has led to tremendous savings.

Keeping the Discussion Going into 2023 and Beyond
This initial podcast episode is only the beginning of the conversation. After this main episode airs, the show will spin off into various conversations, called 360its, which aim to generate more conversation from a variety of patients. Using an array of platforms (social media, e-blasts, existing webinar watch parties) to create break out conversations, in addition to generating audiograms and video clips from this existing episode, AiArthritis can keep the discussion going well into 2023 and beyond.
Watch Episode 77 of the AI Arthritis Voices 360 podcast here.

In August, ASBM recorded two new entries in its ongoing continuing education (CE) series in partnership with the Ohio State University College of Pharmacy. These represent part 4 and 6 of the 7-part series covering a wide range of biosimilar policy issues. View the previous three entries here.

Module 4: Physician Perspectives on Biosimilars

In this module, ASBM Chair Ralph McKibbin, MD FACP FACG AGAF shares survey data from physicians in 13 countries, including U.S. (n=401, 2021) and Europe (n=579, 2019). Physician attitudes on a variety of aspects of biosimilars are examined including: confidence in their safety and efficacy, comfort level with prescribing biosimilars, physician-led switching of patients, third-party switching for cost/coverage reasons, implications of interchangeability designations and distinct suffixes, and payer coverage and reimbursement practices. The lecture is followed by a discussion portion between Dr. McKibbin and OSU College of Pharmacy Professor Philip Schneider.

Module 5: The Biosimilar Market

This module is hosted by Professor Philip Schneider and examines the reasons for increasing biosimilar uptake, and various factors which contribute to their gaining market share. Among these are building physician confidence through data, robust post-market surveillance to address concerns about abbreviated pathways, the preservation of physician and patient choice, multiple payer-reimbursed products competing on a level playing field, and downward price pressure resulting from competition. The mature biosimilar markets of Europe are analyzed in great detail, and lessons regarding best practices are drawn. The current U.S. biosimilar market is also discussed, including an examination of biosimilars which have achieved significant, even dominant, market shares.

Future entries in the CE series will include Patient Perspectives on Biosimilars, featuring ASBM Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association; and PBM and Payer Practices, featuring Immediate Past ASBM Chair Madelaine Feldman, MD FACR.

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

View the course outline here.

View a promotional trailer for the CE series here. 

On August 2nd, an op-ed by Andrew Spiegel was published in which he argues against price controls for advanced therapies- including biologic medicines used to treat cancer. Mr. Spiegel is Executive Director of the Global Colon Cancer Association and a Member of ASBM’s Steering Committee.

In the op-ed, Spiegel lays out how the H.R. 5378/The Inflation Reduction Act’s provision permitting the federal government to “negotiate” lower drug prices with manufacturers will result in fewer innovative drugs for patients:

In other words, companies and investors are assuming a great deal of risk when they invest in a new drug — a risk multiplied by the Inflation Reduction Act’s price controls.

A recent study by the University of Chicago, for example, found that the legislation’s price controls would result in a more than 18% drop in investment in drug research through 2039, with an estimated 135 fewer drugs being introduced over that time period.

I certainly support making prescriptions more affordable, but the drug-price “negotiation” provision of the Inflation Reduction Act is a misguided way to do that. Let’s hope lawmakers realize they are making a serious misdiagnosis — before it is too late.

The Inflation Reduction Act was signed into law August 16th, 2022.

On August 2nd, the Food and Drug Administration (FDA) approved the Cimerli (ranibizumab-eqrn) injection as interchangeable with, Lucentis (ranibizumab injection).This is the 37th biosimilar approval in the United States, the third interchangeable biosimilar approved, and the first interchangeable in the ophthalmic space.

Cimerli is a vascular endothelial growth factor (VEGF) inhibitor and is approved for the same indications approved for its reference product, Lucentis.

A biosimilar is a biological product that is highly similar to an existing FDA-approved biological product, known as a reference product. The biosimilar must also have no clinically meaningful differences in terms of safety and effectiveness from the reference product. A biosimilar sponsor may choose to also seek an interchangeability determination by demonstrating that their product also meets specific requirements outlined in the Public Health Service Act.

In addition to meeting the same standard for biosimilarity, additional requirements for interchangeability include a determination that the proposed interchangeable can be expected to produce the same clinical result as the reference product in any given patient; and that the risk in terms of safety or diminished efficacy of alternating or switching between the proposed interchangeable and the reference product is not greater than the risk of using the reference product without such alternation or switch.

An interchangeable product may be substituted for the reference product at the pharmacy without consulting the prescriber—a practice commonly called “pharmacy-level substitution” — subject to state law.

Read more about the approval here. 

ASBM and the Generics and Biosimilars Initiative are preparing reports on the two webinars the organizations recently co-hosted. The reports will appear in an upcoming issue of GaBI Journal. The reports will summarize the presentations of the speakers and address audience questions unable to be answered answer during the programs due to time constraints. The two webinars may be viewed at the links below.

On July 20th, 2022 ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a 2-hour webinar entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”. The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship.

Watch video of the Non-Medical Switching webinar here. 

The Non-Medical Switching webinar was the second in a series of webinars hosted by ASBM and GaBI this year highlighting key biosimilar policy issues. The first entry, hosted June 29th, examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US” and may be watched here. 

The discussion will continue in the third webinar in the series, “Ophthalmic Biosimilars” in October 2022. More information will be available soon.

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

On July 20th, ASBM and the Generics and Biosimilar Initiative (GaBI) will co-host the second in a series of webinars about key biosimilar policy issues. The webinar is entitled “Non-Medical Switching of Biologicals/Biosimilars: Canada, Europe and the US: Overview of Non-Medical Switching Practices of Biologicals/Biosimilars in Different Regions and the Importance of Safeguarding the Physician–Patient Relationship”, and will run from 10:00 am – 12:00 pm (EDT) on July 20th.

Register for the event here. 

Academic clinicians, patient advocates, policymakers and regulatory experts from Canada and the US will share their experience and knowledge on medical switching and principles and guidance on interchangeability of biologicals/biosimilars, highlighting the specific concerns on, and the importance of a multi-stakeholder approach protecting the physician–patient relationship in the practice of non-medical switching of biologicals/biosimilars. The event will also contain a panel discussion and Q&A.

Topics discussed will include:

• Overview of biologicals/biosimilars switching policies in Europe and the US – Michael S Reilly, Esq, Alliance for Safe Biologic Medicines, USA
• Current state of non-medical switching policies of biologicals/biosimilars in Canada – Gail Attara, Gastrointestinal Society, Canada
• US physicians’ concerns/experience of non-medical switching of biologicals/biosimilars – Ralph McKibbin, MD, FACP, FACG, AGAF, Pennsylvania Society of Gastroenterology/Digestive Disease National Coalition, USA
• Interchangeability of biologicals/biosimilars: US perspective -Leah Christl, PhD, Amgen, USA
• Patients’ perspective and expectations of non-medical switching of biologicals/biosimilars – Durhane Wong-Rieger, PhD, Canadian Organization for Rare Disorders
• Canadian non-medical switching policies – implications for physicians and patients.

The discussion will continue in the third webinar in the series, “Ophthalmic Biosimilars” in September 2022. More information will be available soon.

Register for the July 20 webinar

ASBM and GaBI Host Webinar on Biosimilar Success in Europe and US

On June 29th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled “Key Factors for Successful Uptake of Biosimilars: Europe and the US: measures taken for improving biosimilar uptake and the potential role of healthcare providers and patients”. The event featured a keynote presentation by former U.S. Deputy Secretary of Health and Human Services Eric David Hargan.

Other speakers at the two-hour event included:

• Michael S Reilly, Esq, Executive Director, Alliance for Safe Biologic Medicines
• Ralph McKibbin, MD, FACP, FACG, AGAF, Pennsylvania Society of Gastroenterology/Digestive Disease National Coalition
• Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Ohio State University College of Pharmacy
• Chad Pettit, MBA, Global Biosimilars Commercial Lead, Amgen
• Andrew Spiegel, Esq, Global Colon Cancer Association

The event concluded with a panel discussion and Q&A session between participants, hosted by federal health policy expert Steven Stranne, MD, JD.

ASBM will share video of the archived event when it becomes available.

View the Webinar Agenda here. 

On June 28th, ASBM Executive Director Michael Reilly presented at a Webinar hosted by the International Federation on Ageing (IFA) entitled “Emerging Trends in Ophthalmic Biosimilars Policy in Canada”. The webinar was part of IFA’s Eye See You educational program about biosimilars in ophthalmology.

View the webinar agenda here.  
Mr. Reilly’s presentation (Part 1, Part 2) was entitiled “An Analysis of Biosimilars Policies: the European, American, and Canadian Landscape”. In the presentation, Reilly discussed several features of the very successful European approach to biosimilars, which is highly collaborative and patient-focused and has resulted in tremendous uptake of biosimilars and robust, sustainable markets.

While a newer and less mature biosimilar market than those of Europe, the U.S. is quickly catching up, Reilly emphasized- with its rapid pace of approvals and uptake rates frequently in the 50-80% range- figures comparable to those seen in many European countries.

Europe’s success, Reilly argued, is due in large part to its near-total absence of automatic substitution, and its preservation of physician choice. In nearly every Western European country, for example, physicians may choose between multiple different products, all of which are reimbursed. He contrasted this approach with that of British Columbia, Alberta, New Brunswick, and Quebec- which have attempted to boost uptake through policies which forcibly switch patients from their physician-chosen medicines to government-preferred products.
“Contrary to the assertions of their proponents, Canada’s policies represent a stark contrast with those of Western Europe- which shows that forced-substitution is not necessary to acheive high uptake and savings. No European country has stopped reimbursement of an originator product through a government fiat.The closest European analogue to the policies of these provinces might be Eastern European countries like Estonia, Latvia, and Poland- in which forced substitution is routinely permitted.”

Presentations from the event will be made available in the coming weeks. 

View Mr. Reilly’s presentation here: Part 1, Part 2
View the entire recorded webinar here. 

On June 20th, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF presented a poster at the DIA Global Annual Meeting 2022 in Chicago, IL. The poster was entitled “U.S. Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” and featured results from ASBM’s 2021 survey of 401 U.S. physicians. Among its key findings:

• Nearly all physicians surveyed expressed confidence in biosimilars – with 92% confident in their safety and efficacy.
• In addition, 89% are comfortable prescribing to a new/bio-naive patient, and 80% with switching a patient to a biosimilar.
• Despite this, a majority (58%) are uncomfortable with a switch initiated by a third-party for non-medical reasons. 89% maintain that they, with their patients, should have sole control over treatment choices.
• 67% consider it “very important” or “critical” that they are able to prevent a substitution they feel is inappropriate.
• A strong majority (71%) believed that payers should reimburse multiple biological products in a given class, including both originator product and its biosimilars; 74% considered it important that coverage decisions consider factors other than price.
• The vast majority (73%) of physicians do not believe that the FDA’s use of a suffix (to distinguish biosimilars from their reference
• product and other biosimilars to that product) implies inferiority.
• In addition, a biosimilar being designated as “interchangeable” by the FDA makes a majority (57%) more comfortable prescribing it, and with pharmacy-level substitution in place of the originator (59%).

View the poster here. 

View a video walkthrough of the poster my Dr. McKibbin here. 

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

ASBM-GaBI Webinar #2:
Non-Medical Switching of Biologicals/Biosimilars: Canada, Europe and the US

Virtual (Register here) – July 20, 2022

World Drug Safety Congress

Boston, MA – October 4-5, 2022

WHO 75th INN Consultation

Geneva, Switzerland – October 18, 2022

Festival of Biologics Europe 2022

Basel, Switzerland – November 2-4, 2022

On July 20th, 2022 ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a 2-hour webinar entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”.  The two-hour event offered an overview of non-medical switching practices in different regions and focused on the importance of safeguarding the patient-physician relationship.

Watch video of the webinar here. 

The Non-Medical Switching webinar was the second in a series of webinars hosted by ASBM and GaBI this year highlighting key biosimilar policy issues. The first entry, hosted June 29th, examined “Key Factors for Successful Biosimilar Uptake in Europe, Canada and the US” and may be watched here. 

During the webinar, academic clinicians, patient advocates, policymakers and regulatory experts from Canada and the US shared their experience and knowledge. Topics discussed included an overview of non-medical switching policies in different countries; physician and patient concerns with non-medical switching; interchangeability of biolosimilars in the US and Canada,  the importance of a multi-stakeholder approach protecting the physician–patient relationship when making substitution decisions.

Presentations included:

• Overview of biologicals/biosimilars switching policies in Europe and the US – Michael S Reilly, Esq, Alliance for Safe Biologic Medicines, USA
• Current state of non-medical switching policies of biologicals/biosimilars in Canada – Gail Attara, Gastrointestinal Society, Canada
• US physicians’ concerns/experience of non-medical switching of biologicals/biosimilars – Ralph McKibbin, MD, FACP, FACG, AGAF, Pennsylvania Society of Gastroenterology/Digestive Disease National Coalition, USA
• Interchangeability of biologicals/biosimilars: US perspective – Leah Christl, PhD, Amgen, USA
• Patients’ perspective and expectations of non-medical switching of biologicals/biosimilars – Durhane Wong-Rieger, Canadian Organization for Rare Diseases
• Canadian non-medical switching policies – implications for physicians and patients – Philip Schneider, MS FASHP FFIP; Ohio State Univeristy College of Pharmacy

Following the presentations, the event concluded with a panel discussion and Q&A session moderated by Steven Stranne, MD, JD (USA). Panelists included:

• Michael S Reilly, Esq, (USA)
• Ralph McKibbin, MD, FACP, FACG, AGAF (USA)
• Leah Christl, PhD (USA)
• Philip Schneider, MS FASHP FFIP
• Jaymee Maaghop, Gastrointestinal Society (Canada)
• Urvashi Rathod, International Federation on Ageing (Canada)

The discussion will continue in the third webinar in the series, “Ophthalmic Biosimilars” in September 2022. More information will be available soon.

View the July 20th Webinar on Non-Medical Switching here.

View the June 29th Webinar on Key Factors for Successful Biosimilar Uptake here. 

A survey of 143 breast cancer patients and 33 oncologists examined their experiences during non-medical switching to a biosimilar trastuzumab from the reference product. The survey, which appeared in Breast Cancer Research and Treatment, suggested there is inadequate information for patients who are non-medically switched to a biosimilar. This is “inconsistent with best practices of patient-centered communication,” the authors concluded, and is a challenge to both the uptake of trastuzumab biosimilars and the physician-patient relationship.

Among the study’s findings:

• In 40.8% of responses, patients reported receiving no prior notification that they would be switching to a biosimilar. Negative emotions regarding the lack of notification were common.
• A physician discussed biosimilars with 26.4% of patients before switching, a chemotherapy nurse discussed the switch with 15.5% of patients, and in other cases, an advanced practice provider, pharmacist, or insurer discussed biosimilars with the patient prior to non-medical switching.
• Only 11% of surveyed patients reported being satisfied with the information they received.

The study authors collected comments representative of the switched patients’ experience. “I thought [the biosimilar] was the same.” said one. “Literally any information would have been more than I was given,” said another.

Read the full study here. 

The U.S. Food and Drug Administration is hosting a one-day virtual public workshop entitled, “Increasing the Efficiency of Biosimilar Development Programs,” on Monday, September 19, 2022. The event will run from 9am-4pm ET.

This public workshop will discuss statistical, scientific, and clinical methods for streamlining comparative clinical studies associated with biosimilar product development programs. This workshop will support the sharing of innovative ideas on the statistical approaches and clinical study design elements for streamlining these comparative clinical studies, which are the most expensive and operationally complex aspects of product development programs. Examples of these ideas include reducing sample sizes or modifying certain aspects of study designs that could improve the efficiency of biosimilar development overall.

The workshop will be held virtually for participants and will include presentations and panel discussions from speakers and panelists from the FDA, as well as external subject matter experts in biostatistics. This workshop will be of particular interest to biosimilar developers, academic researchers, and other stakeholders.

This virtual workshop is open to the public; register here. 

In July, Amgen released a preview of its 2022 Trends in Biosimilars Report. The preview shares highlights of the U.S. biosimilar market ahead of a full report due this fall. Among the report’s findings:

• While Europe was an early leader in approving biosimilars, the U.S. is approving them more rapidly: In the 8 years after the EU approved the first biosimilar (2006), there were 15 approved biosimilars. By contrast, in the 8 years after the US approved the first biosimilar
  (2015), there were 36 approved biosimilars.
• Biosimilars have gained significant U.S. market share in the majority of therapeutic areas where they have been introduced: 80% for filgrastim trastuzumab and bevacizumab biosimilars; 60% for rituximab biosimilars; and 40% for infliximab, pegfilgrastim, and erythropoietin-stimulating agent (ESA) biosimilars.
• Biosimilars are attaining significant market share more quickly: for therapeutic areas with biosimilars launched in the last 3 years, the average share was 74%. For therapeutic areas with biosimilars launched prior to 2019, the average share after 3 years was 38%.

The full report is expected in Q3 of 2022.

Read the 2022 Trends in Biosimilars Report Preview here.

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

ASBM-GaBI Webinar #3: Ophthalmic Biosimilars

Virtual – September 2022 (Date TBD)

World Drug Safety Congress

Boston, MA – October 4-5, 2022

WHO 75th INN Consultation

Geneva, Switzerland – October 18, 2022

Festival of Biologics Europe 2022

Basel, Switzerland – November 2-4, 2022

On June 29th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host a webinar entitled “KEY FACTORS FOR SUCCESSFUL UPTAKE OF BIOSIMILARS: EUROPE AND THE US: measures taken for improving biosimilar uptake and the potential role of healthcare providers and patients”

The online event will run June 29th from 10:00 am – 11:50 am EST.

Register for the event here. 

An academic clinician with a specialty in gastroenterology, a pharmacist, a patient advocate, and a market access expert will share their experience with biosimilars, highlighting successes and challenges, their perspectives on prescribing and switching of biosimilars, and measures to increase biosimilar adoption, including the role of physicians and other healthcare providers.

Speakers will include:

• Michael S Reilly, Esq, Executive Director, Alliance for Safe Biologic Medicines
• Ralph McKibbin, MD, FACP, FACG, AGAF, Pennsylvania Society of Gastroenterology/Digestive Disease National Coalition
• Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Ohio State University College of Pharmacy
• Chad Pettit, MBA, Global Biosimilars Commercial Lead, Amgen
• Andrew Spiegel, Esq, Global Colon Cancer Association

View the Agenda here. 

Register for the event here. 

The discussion will continue at the next webinar on “Non-medical switching of biologicals/biosimilars: Canada, Europe, the US” in July 2022. More information will be available soon.

On May 31st, the Ohio State University College of Pharmacy released a series of promotional videos for its 7-hour continuing education (CE) program on biosimilars.The videos consist of an overview of the educational program featuring all the presenters, as well as a biographical sketch of each presenter.

The program was developed in partnership with ASBM and covers a broad variety of biosimilar topics. The program is fully ACPE-accredited and available to pharmacists nationwide. The course consists of seven modules, of which the first three are currently available. Additional modules will be added in the coming weeks.

• Introduction to Biologics and Biosimilars (Philip Schneider, MS, FASHP, FFIP)
• Biosimilar Substitution and Interchangeability (Philip Schneider, MS, FASHP, FFIP)
• Biosimilar Pharmacovigilance (Philip Schneider, MS, FASHP, FFIP)
• The Biosimilar Market (Philip Schneider, MS, FASHP, FFIP)
• Physician Perspectives on Biosimilars (Ralph McKibbin, MD, FACP, FACG, AGAF)
• Patient Advocate Perspectives on Biosimilars (Andrew Spiegel, JD)
• Biosimilars: Payer and PBM Practices (Madelaine Feldman, MD, FACR

The course is presented by the University’s Office of Continuing Professional Development and may be accessed here (registration required).

View the course outline here.

Watch the course overview video here.

Watch the biographical video for Professor Schneider here.

Watch the biographical video for Dr. McKibbin here.

Watch the biographical video for Dr. Feldman here.

Watch the biographical video for Mr. Spiegel here.

On May 27th, the U.S. FDA approved Fylnetra (pegfilgrastim-pbbk), a biosimilar to pegfilgrastim.

Fylnetra is a leukocyte growth factor, indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Fylnetra is expected to launch sometime during the second half of 2022.

Fylnetra is the 36th biosimilar approved by the FDA, and the fifth pegfilgrastim biosimilar approved.

Read more about the approval here. 

On May 10-11, ASBM sponsored a two-day Biosimilars Training Program, presented by the Global Colon Cancer Association in partnership with the World Patient Alliance. This live event was open to patients from any disease state and drew hundreds of representatives from patient advocacy organizations worldwide.

Those who were unable to attend the live event on May 10-11 may now watch the sessions on-demand here. 

This two-day program educates patients worldwide about biosimilars and equip them with the tools they need to be more effective advocates and help ensure their country’s biosimilar policies work for the patients they represent. Several ASBM representatives led sessions; these included:

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

Patient Advocacy Toolkit
Attendees also receive access to a Biosimilars Patient Advocacy Toolkit, which contains:

• Key Terms and Definitions
• Lessons from Patient Advocacy Experts
• Fact Sheets describing the basic science of biosimilars and key policy issues like Non-Medical Switching, Biosimilar Substitution, and Naming & Pharmacovigilance
• Questions to Ask Your Doctor About Biosimilars
• Sample Position Statements on key biosimilar policy issues like maintaining physician and patient control of treatment decisions; substitution practices; and post-market surveillance.
• Sample Letters to Health Ministries on topics including automatic substitution, forced switching, and distinct naming of biologics
• Tips for Letter Writing
• Additional Resources for Patients- including educational videos and handouts from major regulators and patient advocacy organizations

Access the Biosimilar Training Program and Patient Advocacy Toolkit here.

On May 6, H.R. 7667 was introduced in the U.S. House of Representatives that would “amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes”.

Title IV of the package, also known as the “Biosimilar User Fee Amendments of 2022”, deals specifically with biosimilars. Biosimilar user fee programs support the review of biosimilar product applications.

The bill was referred to the House Committee on Energy and Commerce, which voted 30-0 to advance the bill. In a press release, Committee Chairman Frank Pallone, Jr said of the bill:

This legislation would reauthorize FDA’s user fee programs, which are critically important to ensure the agency has the funding it needs so that Americans can continue to trust that the drugs and medical devices they use are safe and effective.

This comprehensive package also includes important provisions that will help lower drug costs for the American people by promoting competition for generic drugs.

Read the House Energy and Commerce’ Committee’s press release on the bill here.

Read the text of H.R. 7667 here. 

The forced-switching policies of some Canadian provinces result in large increases in uptake, yet remain controversial, according to an analysis of these policies in the Canadian Medical Association Journal. From the article:

The use of switching policies — when biosimilars are not considered interchangeable or may have garnered additional indications indirectly — is controversial. A joint position statement from the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada supported the use of biosimilar infliximab in treatment-naive patients but recommended against switching from treatment with originator drugs among those who were already stable. 

In contrast, the Canadian Rheumatology Association and Canadian Spondylitis Association generally support biosimilar substitution that involves informed consent and the option to switch back to the reference biologic. 

It is important to emphasize that division remains, concerns regarding biosimilar switching persist, and there are real impacts on patient and provider autonomy as a result of biosimilar switching.

The authors of the analysis conclude that “salient concerns among patients and providers persist, and policy-makers should proceed with caution as further evaluation is necessary.”

Read the full article here. 

On June 20th, ASBM Chairman Ralph McKibbin, MD will present a poster entitled “U.S. Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” at the 2022 DIA Global Annual Meeting in Chicago, IL. The poster is based on the findings of ASBM’s September 2021 survey of 401 U.S. physicians.

Dr. McKibbin will present the survey findings on June 20th between 12:00-1:15pm at the professional poster exhibit area at the McCormick Center West Convention Hall. The meeting will run from June 19th through the 23rd.

Read more about the topics covered by the survey here. 

Watch a video preview some of the findings here. 

Register for the 2022 DIA Global Annual Meeting here. 

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

BIO International Convention

San Diego, CA – June 13-16, 2022

DIA Global Annual Meeting 2022

Chicago, Illinois – June 19-23, 2022

ASBM-GaBI Webinar:
Key Factors for Successful Uptake of Biosimilars in Europe & US 

Virtual (Register here) – June 29, 2022

World Drug Safety Congress

Boston, MA – October 4-5, 2022

WHO 75th INN Consultation

Geneva, Switzerland – October 18, 2022

Festival of Biologics Europe 2022

Basel, Switzerland – November 2-4, 2022