Safe Biologics

Health Canada has opened a consultation on its draft Handbook for healthcare professionals on biosimilar biologic drugs. This publication was developed for the purpose of informing and educating healthcare professionals in Canada regarding biosimilars. The handbook was developed in consultation with a working group composed of subject matter experts from Health Canada, and external healthcare professionals representing a range of professional associations.

The document covers numerous issues including: the differences between biosimilars and generic drugs, the regulation of biosimilars in Canada, monitoring the safety and effectiveness of biosimilars, the role of healthcare professionals in improving pharmacovigilance for biosimilars, and discussions about switching.
The consultation is open until Friday, April 29th, 2022.

Interested parties are invited to email comments to brddopic-bpcidmbr@hc-sc.gc.ca.

Registration is now open for the ASBM-sponsored Biosimilars Training Program which will be presented May 10-11, 2022 by the Global Colon Cancer Association, in partnership with the World Patient Alliance. The virtual event is open to patients from any disease state. Register here. 

This two-day program will educate 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 will be leading sessions, including:

• Introduction to Biologics and Biosimilars –Philip Schnieder, 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 Schnieder, MS, FASHP, FFIP; ASBM Advisory Board Chair
• Biosimilar Pharmacovigilance – Philip Schnieder, MS, FASHP, FFIP; ASBM Advisory Board Chair
• US Patient Perspectives – Andrew Spiegel, Executive Director of GCCA and ASBM Steering Committee Member

Patient advocates from around the world will also share their biosimilar experiences and advocacy strategies. Join these and other speakers to learn about the benefits, as well as the new challenges biosimilars bring for patients.

Register for the Biosimilar Training Program here.

On March 8th, ASBM Advisory Board Chair Philip Schneider recorded the third in an ongoing series of Continuing Education (CE) courses produced in partnership with Ohio State University College of Pharmacy’s Office of Continuing Professional Development.

The third entry, entitled “Biosimilar Pharmacovigilance”, examines the unique pharmacovigilance challenges that biosimilars pose due to having an abbreviated approval pathway, while simultaneously sharing a non-proprietary name with their reference product and other biosimilars to that product.

The importance of accurate attribution of adverse events is discussed, as are various approaches to addressing this challenge used by countries around the world to varying degrees of effectiveness. The U.S. biologic pharmacovigilance and nomenclature system is also examined in detail, as is the WHO-proposed international nomenclature standard.

The course is fully ACPE accredited and available to pharmacists nationwide.

View the OSU CE Courses here (registration required)

Visit the Ohio State University College of Pharmacy’s Office of Continuing Professional Development here. 

From March 9-11, ASBM participated in the Festival of Biologics USA 2022, held in San Diego, California. Several ASBM representatives presented on a variety of topics, and participated in several discussion panels at the three-day conference.

On March 9th, ASBM Advisory Board Chair Philip Schneider gave a plenary presentation on the current biosimilars landscape, highlighting factors which are contributing to biosimilars gaining market share in the U.S. Among these are greater discounts resulting from increased competition, as well as greater physician confidence in biosimilars due to strong FDA data requirements and increased familiarity. View his presentation here. 

On March 11th, Schneider gave a presentation in the conference’s “Real World Evidence” (RWE) track entitled “Problems with pharmacovigilance programs: Opportunities for improvement.” This presentation highlighted some of the unique pharmacovigilance challenges of biosimilars, areas of concern, and strategies for improving biosimilar pharmacovigilance globally.  View this presentation here: Part 1 Part 2

Following his presentation, Schneider moderated one of the conference’s two closing panel discussions, entitled “Promoting biosimilar uptake”. This discussion examined the impact of interchangeable biosimilars on the biosimilar landscape and the role of competition in an increasingly active biosimilars pipeline.

The second closing panel discussion was moderated by ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. It is entitled “Market access dynamics and the future across different therapeutic areas” and will examine (e.g. arthritis, oncology, opthalmology, hematology, etc).

One topic of this discussion was the possibility of switching patients at the Veterans Health Administration (VHA) en masse to preferred biosimilars, in order to realize cost savings across a large health system. Mr. Spiegel raised concerns with this approach, citing a recent study published in the journal Current Medical Research and Opinion, which examined US VHA patients who were switched from innovator infliximab to the VHA-preferred biosimilar. The study found that those who were switched from the reference product to the biosimilar were almost 3 times more likely to stop treatment and 5 times more likely to switch to another innovator biologic.

The study also found that 91% of the patients who stopped the biosimilar switched back to the originator product. “Reasons for discontinuation and switching are unknown,” investigators wrote in the study.

Learn more about the Festival of Biologics USA 2022 here. 

On March 9th, a bill was introduced in the U.S. House of Representatives that would eliminate the requirement for a biosimilar to have the same strength as the originator product upon which it is based.

H.R. 7047, the “Lowering Costs by Improving Biosimilar Uptake Act”, would amend title III of the Public Health Service, permitting the Secretary of Health and Human Services to waive this approval requirements:

(I) The Secretary may determine, in the Secretary’s discretion, that an element described in clause (i)(I), or in clause (i)(IV) with respect to the strength of a biological product, is unnecessary in an application submitted under this subsection.

In addition to having the same benefits, potential side effects, and route of administration and the originator product- biosimilars are currently requiredto have the same dosage and strength as the reference product.

The bill has been referred to the U.S. House Energy and Commerce Committee. ASBM will continue to monitor its progress.

From March 6th-8th, the Digestive Disease National Coalition (DDNC) held its 32nd Annual Public Policy Forum, the theme of which was “Putting Patients First.” The focus of the meeting was to connect the gastrointestinal disease community and advocate with congressional leaders with a common agenda. There were over 200 participants from 33 states and Washington, DC. ASBM Chairman Ralph McKibbin, MD, a past President of DDNC, participated in the policy forum as part of the Pennsylvania state team.

A key legislative priority discussed at the Forum was the Safe Step Actcurrently before the U.S. House and Senate. Step therapy is a utilization management technique commonly used by health plans to limit access to expensive medications such as biologic for chronic diseases;  but there are no standardized guidelines for the practice. This has been shown to lead to increased patient and system costs, delays in care, and worse patient outcomes. S 464/HR 2163, the Safe Step Act, would:

1. Ensure plans offer a clear step therapy exceptions process
2. Establish five circumstances when a step therapy exception request should be granted by the plan
3. Require plans to respond to an exceptions request within 24-72 hours

During the forum, DDNC held nearly 80 virtual congressional meetings to connect with their legislators, share their patients’ stories, and advocate for their legislative priorities including the Safe Step Act.
Read more about the Digestive Disease National Coalition here.

Read more about the Safe Step Act here. 

The Inspector General for the U.S. Department of Health and Human Services has announced a study of use and cost trends of biosimilars and their reference biologics covered by Part B over time. From the announcement:
Medicare Part B and beneficiaries have the potential to spend less on prescription drugs with the increased use of biosimilars rather than their reference biologics, but their use remains low. Limited biosimilar use in Part B may be related to how providers are reimbursed for these drugs-currently, providers do not have strong financial incentives to use less expensive biosimilars.

In addition to examining use and cost trends, it will also determine how much Medicare and beneficiaries paid for biosimilars and reference biologics covered by Part B in 2021, and then compare those costs to determine how much Part B and beneficiaries could have spent with increased use of biosimilars or with different reimbursement policies.

Read the HHS Inspector General’s announcement here.

Missed last month’s ASBM Newsletter?

Read it Here.

ASBM/GCCA Biosimilars Training Program

Virtual – May 10-11, 2022

DIA Global Annual Meeting 2021

Chicago, Illinois – June 19-23, 2022

On January 27th, ASBM joined other patient advocacy organizations and physician groups in submitting a coalition letter to the U.S. Department of Health and Human Services (HHS), urging the Department to prohibit the practice of copay accumulator adjustment policies. The coalition letter was submitted as part of the comment period on the HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule (BPPR).

The letter was branded by the All Copays Count Coalition (ACCC), which is composed of groups serving the interests of people with chronic and serious health conditions that rely on copay assistance in various forms to make medically necessary drugs affordable.The comment letter was signed by 126 patient advocacy and physician organizations.

From the letter:

We are extremely disappointed that the proposed 2023 NBPP rule does not include any reference to copay accumulator adjustment policies, which financially benefit insurance issuers and pharmacy benefit managers while making crucial treatments unaffordable for patients. We strongly urge you to address this issue in the final rule by requiring that insurers and Pharmacy Benefit Managers (PBMs) count all copayments made by or on behalf of an enrollee toward the enrollee’s annual deductible and out-of-pocket limit. 

The proposed NBPP for 2023 seeks to refine Section 156.125 of the Affordable Care Act (ACA), directly addressing the issue of discriminatory benefit design, intending to ensure that insurance plans do not discriminate against people living with chronic illness. While we support CMS’ intention to ensure that benefit design reflects clinical evidence rather than an effort to discriminate against people with high health care needs, we strongly urge CMS to also prohibit use of copay accumulator adjustment policies, which discriminate against people living with chronic illness. 

Copay accumulator adjustment policies undermine ACA protections prohibiting insurers from charging people with pre-existing conditions more than healthier enrollees. Copay assistance is generally only available for specialty or medications without a medically equivalent generic, which are used by people with serious, complex chronic illness. These policies subvert the benefit of co-pay assistance, thereby discriminating against people living with chronic conditions. 

Read the full letter here.

Read more about the Benefit and Payment Parameters for 2023 Proposed Rule here.

Learn more about the All Copays Count Coalition here.

On January 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR participated in a webinar entitiled “What’s the Hold-Up? Overcoming Barriers to the Use of Biosimilars,” hosted by The Center for Biosimilars. At the forum, Dr. Feldman discussed the role of payers like insurance companies and pharmacy benefit managers (PBMs) in contributing to higher drug costs.

Although there are cases where providers choose not to prescribe biosimilars, in others it may be due to physicians ultimately losing the ability to choose a therapy for their patients based on what is the lowest priced product or what is in the practice’s inventory, according to Dr. Feldman, who is president of the Coalition of State Rheumatology Organizations.

Savings and rebates that payers negotiate with manufacturers are often not designed to save patients money, Dr. Feldman explains, but are instead intended to increase profits for payers, who often negotiate contracts with companies to place more expensive products on formularies:

“Cost and price are 2 different things and when the middlemen talk about why we choose the lowest net costs, that actually means the highest profit. Their fiduciary responsibility is to their shareholders. It’s unfortunate but it’s the truth. It is not to the health care system, it is not to patients, and it is not to providers. And anything that they can do to increase their profit involves using higher price drugs because…all of the price concessions are a percentage of the list price.”

Dr. Feldman recently testified about PBM practices testified at a public hearing of the Congressional Oversight Committee entitled “Reviewing the Role of Pharmacy Benefit Managers in Pharmaceutical Markets”, held November 17th, 2021. From Dr. Feldman’s testimony:
The out-of-pocket costs for these miraculous RA medications – as well as medications for many other serious, chronic illnesses – have risen to levels where many patients simply can no longer afford them, and that is true even for biosimilars. Clearly, something is not working the way Congress intended. That something begins with the formulary…
High drug prices are not a mere byproduct of this system; they are at the heart of its design, since a drug’s list price must be high so as to offer “headroom” for these discounts, rebates, and fees to the PBM. This creates a broken market in which competition actually raises prices. In this way, our drug pricing system is more akin to selling a house [winner = highest bidder] than building a house [winner = lowest bidder].

Learn more about Center for Biosimilars webinar here.

Read Dr. Feldman’s testimony about PBM practices here. 

From March 9-11, ASBM will participate in the Festival of Biologics USA 2022, held in San Diego, California. Several ASBM representatives will be presenting on a variety of topics, and moderating several discussion panels at the three-day conference.

On March 9th, ASBM Executive Director Michael Reilly will give a Plenary Presentation on the current biosimilars landscape, highlighting factors which are contributing to biosimilars gaining market share in the U.S.

On March 11th, ASBM Advisory Board Chair Philip Schneider will give a presentation in the conference’s “Real World Evidence” (RWE) track entitled “Problems with pharmacovigilance programs: Opportunities for improvement.” This presentation will highlight some of the unique pharmacovigilance challenges of biosimilars, highlight areas of concern, and discuss strategies for improving biosimilar pharmacovigilance globally.

On March 11th, Schneider will moderate one of the conference’s two closing panel discussions, on “Promoting biosimilar uptake”. This discussion will examine the impact of interchangeable biosimilars on the biosimilar landscape and the role of competition in an increasingly active biosimilars pipeline.

The second closing panel discussion will be moderated by ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. It is entitiled “Market access dynamics and the future across different therapeutic areas” and will examine (e.g. arthritis, oncology, opthamology, hematology, etc)

Learn more about the Festival of Biologics USA 2022 and register for the conference here. 

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

From the Executive Summary:

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

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

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

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

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

Read the full Executive Summary here. 

Missed last month’s ASBM Newsletter?

Read it Here.

World Biosimilar Congress USA 2022

San Diego, California – March 9-11, 2022

74th INN Consultation

Geneva, Switzerland – April 5-8, 2022

ASBM/GCCA Biosimilars Training Program

Virtual – May 10-11, 2022

DIA Global Annual Meeting 2021

Chicago, Illinois – June 19-23, 2022