Safe Biologics

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

On April 29th, ASBM submitted comments to Health Canada as part of a stakeholder consultation on its draft Handbook for healthcare professionals on biosimilar biologic drugs. ASBM’s comments focused on the Handbook’s mixed messaging surrounding biosimilar equivalence and switching, including language which implies inaccurately that Canada’s policies are consistent with those of regulators in US and Europe. From the comments:

In fact, many of the automatic- and forced-substitution policies increasingly being implemented in Canada stand in stark contrast to the substitution practices in Europe and the United States.

In nearly every European county, for example, automatic substitution of biologic medicines at the pharmacy level is banned. Forced substitution is also extremely rare, and in nearly every country, physicians are free to choose between multiple reimbursed products. …An ASBM survey of 403 Canadian physicians, all of whom prescribe biologics, revealed that 64% are not comfortable with a third-party switching a patient to a biosimilar for non-medical (i.e. cost) reasons.

In the United States, automatic substitution is permitted only for biosimilars which have provided additional data to FDA demonstrating no loss of efficacy or additional risks following repeated switching between the biosimilar and reference product…82% of the 403 Canadian physicians surveyed believe such studies should be conducted that measure the effects of switching on patient safety and product efficacy, prior to automatic substitution being permitted.

We suggest softening or clarifying language in the Handbook that implies interchangeability of reference products, emphasizing the importance of prescriber responsibility for determining the choice of a biologic for their particular patient, and acknowledging more accurately the regulations in other countries, particularly the EU and USA.

ASBM’ s comments also touch on pharmacovigilance concerns related to Canada’s lack of distinct non-proprietary names for biologic medicines:

The handbook text correctly and appropriately emphasizes the importance of pharmacovigilance programs and clear product identification when dealing with multiple similar biologic products all sharing a non-proprietary name…[yet] the Canadian physician survey revealed that brand name is not consistently used in reporting and the DIN number is not widely used by clinicians:

• Prescribers record only the non-proprietary name 20% of the time when prescribing, which lead to incomplete patient records and the potential for inadvertent or inappropriate substitution.
• In adverse event reporting, 26% of physicians record only the non-proprietary name.

We suggest Health Canada make reference to the importance of distinguishable non-proprietary names and the current problems of relying solely on brand names and the DIN for documentation in medical records and adverse drug event reports.

Read ASBM’s comment letter here in full. 

On April 14, 2022, the Honourable Jean-Yves Duclos, Canadian Minister of Health, issued a statement announcing the Government’s intention related to the coming-into-force of the Amendments to the Patented Medicine Prices Review Board (PMPRB) Regulations. The Minister’s statement advised that Health Canada will proceed with changing the new basket of comparator countries and will not proceed with any of the other amendments. This is what patient groups have been advocating for since 2018, as the Gastrointestinal Society reports.

On June 20th, ASBM Chairman Ralph McKibbin, MD will present a poster entitled “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. While topline findings have been shared privately in meetings with regulators, the full survey data has not yet been released.

Survey respondents were drawn from twelve specialties in which biologics are routinely prescribed (e.g. dermatology, gastroenterology, nephrology, neurology, oncology, rheumatology, etc.) All respondents prescribe biologics in their practice. Topics examined include:

• Confidence in the safety and efficacy of biosimilars
• Willingness to prescribe biosimilars to a new patient
• Comfort level with physician-instituted non-medical switching
• Comfort level with third-party-initiated non-medical switching
• Implications of an FDA designation of “interchangeable”
• Importance of treatment decision authority
• Importance of payer reimbursement of multiple products in a class
• Importance of reimbursement coverage decisions including factors other than price
• Perspectives on different biosimilar substitution and access scenarios
• Implications of FDA biologic naming conventions

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 runs from June 19th through the 23rd.

Register for the 2022 DIA Global Annual Meeting here. 

On April 5th, ASBM participated in the World Health Organization’s 74th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the eighteenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

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

On April 13th, the U.S. Food and Drug Administration (FDA) and The University of Maryland Center of Excellence in Regulatory Science (M-CERSI) held an educational webinar entitled “Biosimilars: A Decade of Experience and Future Directions-Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology”.

In the workshop, leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology shared their experience with biosimilars, their perspectives on how to improve the efficiency of biosimilar evaluations, and how to increase biosimilar adoption, including the role of clinical pharmacology.

The slides and videos for the workshop are now available for viewing online here. 

On April 7th, ASBM sent a letter to Minnesota lawmakers opposing a bill which could potentially increase costs for patients who receive biologic medicines. The bill, HF 1516, was introduced last session but not ultimately adopted. ASBM led a coalition of patient organizations that raised concerns with the bill last spring. From the letter:

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

In effect, this bill requires a pharmacy benefit manager or health carrier that covers ANY biologic product in a given class, to reimburse ALL products in that class, regardless of its actual cost to the payer. The availability of biosimilars currently places downward pressure on net prices by forcing reference product manufacturers to discount their products heavily in order to compete. By requiring health plans to cover all approved products in a class (regardless of net cost), it effectively creates an incentive for all manufacturers to raise their prices.

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

Read ASBM’s full letter on HF 1516 here. 

ASBM/GCCA Biosimilars Training Program (ON-DEMAND)

LearnBiosimilars.org – May 12, 2022 – May 12, 2023

BIO International Convention

San Diego, CA – June 13-16, 2022

DIA Global Annual Meeting 2022

Chicago, Illinois – June 19-23, 2022