Safe Biologics

On August 31st, ASBM Chair Madelaine Feldman, MD, FACR completed her term as ASBM Chair.

ASBM Executive Director Michael Reilly praised Dr. Feldman’s leadership:

Dr. Feldman led ASBM during a difficult time, keeping ASBM engaged on important biosimilar policy issues during the COVID-19 pandemic. As ASBM Chair, she was a tireless champion for patients- sharing physician perspectives at many biosimilar forums nationwide, expanding ASBM’s membership, and co-authoring three important whitepapers during her term.

Dr. Feldman will continue to remain involved with ASBM, joining the Advisory Board as Immediate Past Chair.

ASBM formally announced its new Chairman, gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF; to members on a Full Member Call  September 9th.

The Canada-based Gastrointestinal Society has designed a brief survey to capture the biosimilar switching experience in Alberta and British Columbia, two Canadian provinces which have enacted forced biosimilar switching policies. In these provinces, the policy was changed to only provide public coverage for the biosimilar and no longer provides any coverage for the originator biologic.

The survey is open to residents of Alberta and British Columbia who were prescribed an originator biologic but were made to switch to a biosimilar based on government policy changes. Patient caregivers are also eligible. The survey covers these disease indications:

• ankylosing spondylitis
• Crohn’s disease
• hidradenitis suppurativa
• psoriasis
• psoriatic arthritis
• rheumatoid arthritis
• ulcerative colitis

Eligible Alberta and British Columbia patients and caregivers are encouraged to complete the survey here.

ASBM Presents to Malta Medicines Authority

On August 26th, ASBM’s Advisory Board Chair Philip Schneider gave a series of presentations at a Biosimilars Forum hosted by the Malta Medicines Authority in Valetta, Malta.

Dr. Schneider provided an extensive overview of multiple topics related to biosimilars, including:

• Biosimilars: General Concepts (20 min)
• Biologic Nomenclature and the Importance of Non-proprietary Names (20 min)
• Biosimilar Prescribing and Switching (20 min)
• Biosimilars: Economic Considerations/Pricing (20 min)
• Future of Biosimilar Market/long-term sustainability (20 min)

Dr. Schneider is a frequent lecturer in Malta on the subject of biosimilars. He has served for several years as an external examiner for Doctorate in Pharmacy final students at the University of Malta, and in July 2018 participated in a biosimilars seminar sponsored by the University of Malta, the Malta Medicines Authority, and the Malta Pharmaceutical Association.

View Dr. Schneider’s biosimilar presentations here. 

On August 22nd, the Generics and Biosimilars Initiative (GaBI Journal) published a new whitepaper by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider.

The paper is entitled “A Critical Review of Substitution Policy for Biosimilars in Canada” and highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition policies which have proven successful in driving biosimilar uptake in Europe and the U.S. From the paper:

Successful biosimilar markets in the EU and US have demonstrated that forced medical switching is unnecessary to achieve high uptake of biosimilars and the associated savings…This fosters a robust and sustainable biosimilar market with multiple suppliers in any given product class.

Canada desires a robust biosimilar market share like that observed in Europe. While there may be short-term savings from non-medical switching, a long-term consequence of this policy may be decreased competition resulting from fewer products launches and a negative impact on patient safety. Potential drug shortage issues may develop in the absence of multiple suppliers of biologics in each product class. There would also be likely be an undermining the confidence of both physicians and patients in biosimilars that creates an additional barrier to biosimilar uptake.

The successful uptake of biosimilars in Europe was accomplished by limiting the choice of biologic or forced non-medical switching, but through preserving choice for physicians and patients and by promoting competition among all products approved by regulatory authorities. To foster its success in creating a sustainable biosimilars market, Canadian payers can learn from the lessons learned in more mature markets and implement evidence-based transition policies that consider patients’ needs primary.

The paper will also appear in Issue 3 of the GaBI Journal’s print edition this fall.
Read the online version of the article here.

On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the need for prior physician authorization. The approval is a victory for patients and healthcare providers years in the making, according to the Alliance for Safe Biologic Medicines (ASBM). As the FDA press release states:

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

The FDA announcement comes on the heels of Oklahoma becoming the 50th and final state to permit substitution of interchangeable biosimilars this past April. As with similar laws nationwide, patients and the prescribing physician must be made aware of the substitution, and one may be prevented by the physician if deemed medically necessary.

“For eight years, patient advocacy organizations like ASBM worked with physician and pharmacist societies, manufacturers of both originator products and biosimilars, and state legislatures in fifty states to ensure that biosimilars could be safely substituted and patients nationwide could have access to lower-cost treatment options,” said ASBM’s executive director Michael Reilly.

ASBM’s efforts in this years-long campaign consisted of conducting three nationwide physician surveys, gathering dozens of patient testimonials, physician and pharmacist interviews, letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding educational forums at colleges of medicine and pharmacy.

Read more about the FDA’s approval here. 

On July 27th, ASBM Advisory Board Chair Philip Schneider presented an online Continuing Education (CE) course entitled the “The State of the Biosimilars Market in 2021”. The course was presented in conjunction with Long Island University College of Pharmacy (LIU-Pharmacy) and viewed by more than 150 pharmacists.

The presentation looked at biosimilar market share in the US, Australia, Canada, and the countries of Western Europe and compared the different approaches these countries have used for driving uptake.

While some countries experimented with forced substitution of government-preferred products, those with the most successful biosimilars markets permitted physicians to retain control over prescribing decisions. These countries achieved savings through the increased competition of many products being freely available and reimbursed by payers.

Dr. Schneider also discussed patient and physician concerns with the non-medical switching of patients who are stable on their current therapies; and  how the U.S. interchangeability standard addresses these concerns.

View Dr. Schneider’s presentation here. 

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”.

The second course in the series,“Substitution and Non-Medical Switching” has been updated to include discussion of the July 28 approval of the first interchangeable biosimilar insulin.

The course is presented by ASBM Advisory Board Chair Philip Schneider and covers many topics including:

• Why Should Pharmacists Care About Biosimilars?
• Terminology Review: Biologics, Biosimilars, and Interchangeable Biosimilars
• Issues Surrounding Biosimilar Substitution
• How Do Different Countries Handle Biosimilar Substitution: Automatic?
• Europe, Australia, Canada
• Physician Perspectives on Biosimilar Substitution
• Non-Medical Switching of Biologics: Patient and Physician Concerns
• U.S. Policy: Automatic Substitution of Interchangeable Biosimilars
• Development of State Laws: Pharmacist/Physician Collaboration
• Biosimilars: the Pharmacist’s Role

Upcoming entries will include discussions of the limitations of biologic pharmacovigilance systems; patient and physician perspectives on biosimilars, and a comparison of different countries’ approaches to driving biosimilar uptake.

While the course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to pharmacists nationwide, it is open to all.

Use the code BIOJUNE1 for free access to the first two courses.BIBIOOJUNE1
View the entry in the series: “Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects” here. 

On July 28th, ASBM sent a letter to Congressional leaders expressing our  opposition to H.R.2815, the BIOSIM Act, a bill “to amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.”

The bill proposes to artificially incentivize biosimilar uptake by increasing reimbursement for biosimilars in Medicare Part B to ASP plus 8%, up from the current ASP plus 6%. This troubling proposal is not new, and has wisely been rejected by the Senate several times. In 2019 alone, this policy was defeated in the Prescription Drug Pricing Reduction Act, The BIOSIM Act (H.R. 4455) and The Lower Drug Costs Now Act (H.R. 3). From the letter:

We, the undersigned patient advocates and health care practitioners, have serious concerns with the potential negative impacts of this policy on patient care. It would create financial incentives for physicians to prescribe biosimilars; in effect, it would provide the doctor a 33% bonus for using a biosimilar instead of an originator product.

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.

Read the full letter here. 

Missed last month’s ASBM Newsletter?

Read it Here.

WHO 73rd INN Consultation

Geneva, Switzerland – October 19, 2021

World Drug Safety Congress

Boston, Massachusetts – October 20-21, 2021

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.

Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, Inc.), the Global Colon Cancer Association (GCCA), and individual patients in Minnesota communicated to legislators their concerns with the language. In a letter to Minnesota legislators dated April 26, 2021 and co-written with LADA, Inc, ASBM laid out how the provisions might negatively impact prescription costs for patients:

The legislation assumes that products with lower wholesale acquisition cost (WAC) or “list” price translates into lower costs for healthcare payers and patients. However, list price is the price before any rebates, discounts, or other price concessions are offered by the drug manufacturer. In practice, manufacturers of biologics must compete on net cost in order to secure a preferred formulary position, but due to negotiated discounts with health plans and PBMs, the net price of a reference product may end up being substantially lower than the net price of a biosimilar with a lower WAC/list price.

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 focusing on the WAC rather than the true (net) cost of the medicine after rebates and discounts, the bill’s language removes the incentive to compete on net prices. We believe that this is counterintuitive to the intent of the legislation and will result in higher rather than lower costs for Minnesota patients.

“ASBM, like most patient advocacy organizations, is strongly supportive of legislation written with the goal of realizing cost savings through competition between multiple biologic products” said Executive Director Michael Reilly. “However, the language contained in HF 2128 would have undermined this objective by removing current incentives to compete on price and would have reduced, rather than promoted, affordability of biologics.”

Read one of ASBM’s several letters here. 

Read LADA, Inc.’s letter here.

Read GCCA’s letter here. 

Read Minnesota cancer patient Jason Randall’s letter here. 

View the final Minnesota omnibus health and human services bill here.

On June 24th, ASBM Executive Director Michael Reilly presented at the 15th Biosimilars Congregation. The event was organized to provide insight into the current state of play in the EU with respect to biosimilars and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. It also highlighted key recent developments in regulatory science and regulatory policy in the EU and other international jurisdictions.

Mr. Reilly’s presentation was entitled “Biosimilars: Patient and Physician Perspectives” and drew heavily from ASBM’s surveys of physicians in Australia, Canada, Europe, Latin America, and the U.S.; as well as discussing recent biosimilar policy trends globally.

The presentation focused on three key policy areas: 1) Interchangeability and Substitution; 2) Non-Medical Switching, and 3) Distinguishable Naming.

Reilly emphasized the cautious nature of physicians, who while strongly supportive of biosimilars, are reluctant to change medicines for patients who are doing well on their current therapy. This is evident from European survey data showing high comfort levels prescribing biosimilars to new patients (84%), but also high discomfort with a third-party-initiated switch to a biosimilar for non-medical reasons such as cost (73%).

While automatic substitution is rarely practiced in Europe, such policies have been enacted in Australia over physician and patient objections. In addition, several Canadian provinces have begun forced-switching policies.

British Columbia and Alberta have already implemented forced switching policies, and in April, New Brunswick announced it would follow them. In May, Quebec announced its intention to become the fourth province to require patients to switch to biosimilars.

Quebec’s National Institute of Excellence in Health and Social Services (INESS) had previously released a report called “Safety of switching biologics and their interchangeability”. It found strong opposition to forced switching:

All the learned [physician] societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor…this position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.

Finally, Mr. Reilly discussed the issue of biologic nomenclature. Lack of an international standard was identified by the World Health Organization as a key policy challenge in a 2020 report. In 2014, the WHO’s International Nonproprietary Names (INN) Programme’s Expert Group proposed a distinct naming system built around a Biologic Qualifier (BQ), a four-letter suffixed affixed to an INN shared by an innovator biologic and all biosimilars to that product.

Despite early broad support from many countries including the U.S., Australia, Canada, and Japan; the voluntary standard was never made available to national regulatory authorities.

Currently several countries, including the U.S. and Japan, use distinct suffix systems, while Europe relies on INN and brand name for product identification. Early supporters of the BQ including Australia and Canada have also followed the latter approach, but expressed willingness to harmonize with the WHO standard if it is made available.

View Mr. Reilly’s presentation here. 

On June 15th, the American Medical Association (AMA) passed a resolution opposing the practice of insurers providing financial incentives for patients to switch to a payer-preferred treatment. The resolution was drafted by the American Colloge of Rheumatology (ACR) and passed during the AMA’s June 2021 Special Meeting.

The ACR drafted the resolution after learning Cigna was notifying patients on Cosentyx (secukinumab) that they could qualify for a $500 pre-paid debit card for their medical expenses if they agreed to switch to a Cigna-preferred alternative.

“We are grateful that, through the passage of this ACR-led AMA resolution, the larger house of medicine has agreed with us that financially incentivizing patients to switch medicines is wrong. In recent years, payers have become increasingly aggressive in the tactics they have used to direct patients to the preferred treatments on their formularies,” said Chris Phillips, MD, chair of ACR’s Insurance Subcommittee.

The ACR had previously outlined their concerns with non-medical switching of patients on biologics in an April 2021 letter to Cigna:

“Due to the complex nature of autoimmune diseases, two patients can have very different immune responses to the same medication in the same drug class…This can make finding the treatment that works a challenge, so the decision to choose one biologic over another requires careful clinical evaluation and consideration by a physician and patient. Factors such as an individual patient’s age, gender, diagnosis, medications, specific organ manifestations, antibody status, disease severity, comorbid conditions, and ability to tolerate the route of administration strongly influence the choice of each specific biologic.”

“We are hopeful the AMA’s new stance will increase scrutiny of these practices and encourage policy makers to pass legislation prohibiting financial payments for non-medical switching.” said the ACR statement. The ACR says it plans to work with the AMA to oppose legislation that would explicitly allow this practice.

Read the ACR’s press release about the AMA resolution here. 
Read the ACR’s April 2, 2021 letter to Cigna here.

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”.

While the course is accredited by the American Council on Pharmaceutical Education (ACPE), meaning course credit is available to pharmacists nationwide, it is open to all. 

The first entry in the series is entitled “Biologic and Biosimilar Medicines: Their Purpose, Development, Structure, and Effects”, and is presented by ASBM Advisory Board Chair, Philip J. Schneider, MS, FASHP.

In the presentation, Dr. Schneider provides a basic overview of biologic medicines, biosimilars and discusses key policy considerations affecting pharmacy practice.

The course is offered as a 1 hour CE/homestudy for $10.00, but ASBM is offering the course for FREE when you use the code “BioJune1”.

The second entry in the series is entitled “Substitution and Non-Medical Switching” and will be online in early July. It will cover topics including:

• Why Should Pharmacists Care About Biosimilars?
• Terminology Review: Biologics, Biosimilars, and Interchangeable Biosimilars
• Issues Surrounding Biosimilar Substitution
• How Do Different Countries Handle Biosimilar Substitution: Automatic?
• Europe, Australia, Canada
• Physician Perspectives on Biosimilar Substitution
• Non-Medical Switching of Biologics: Patient and Physician Concerns
• U.S. Policy: Automatic Substitution of Interchangeable Biosimilars
• Development of State Laws: Pharmacist/Physician Collaboration
• Biosimilars: the Pharmacist’s Role

View the CE series here. 

On August 26th, ASBM’s Advisory Board Chair Philip Schneider will present at a Biosimilars Forum hosted by the Malta Medicines Authority. Dr. Schneider will provide an extensive overview of topics related to biosimilars, including:

• General concepts
• Nomenclature and the importance of non-proprietary names
• Prescribing and Switching
• Economic Considerations/Pricing
• Future of Biosimilar Market/long-term sustainability

Dr. Schneider is a frequent lecturer in Malta on the subject of biosimilars. He has served for several years as an external examiner for Doctorate in Pharmacy final students at the University of Malta, and in July 2018 participated in a biosimilars seminar sponsored by the University of Malta, the Malta Medicines Authority, and the Malta Pharmaceutical Association.

Missed last month’s ASBM Newsletter?

Read it Here.

Malta Medicines Authority Biosimilar Forum

Valetta, Malta – August 26, 2021

WHO 73rd INN Consultation

Geneva, Switzerland – October 19, 2021

World Drug Safety Congress

Boston, Massachusetts – October 20-21, 2021

World Biosimilar Congress Europe 2021

Basel, Switzerland – November 9-11, 2021