Safe Biologics

On January 31st, the first biosimilar for adalimumab (Humira) launched in the U.S. market. Amjevita (adalimumab-atto) will launch at a 55% discount over its originator product’s Wholesale Acquisition Cost (WAC). Due to discounts and rebates, insurers seldom pay that price, however. According to Amgen, a second list price 5% below Humira’s will also be available to some payers to account for rebating and discounting practices by pharmacy benefits managers.

Adalimumab is approved to treat a variety of diseases: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Amjevita (adalimumab-atto) was the first adalimumab biosimilar approved by the FDA, in September 2016. Its launch represents the first of up to nine adalimumab biosimilars expected to enter the U.S. market this year.

Read more about the launch here. 

On January 20th, the European Medicines Agency released a Q&A document intended to provide clarity regarding its “Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU,” published in September 2022. That joint statement from the EMA and the Heads of Medicines Agencies (HMA) declared the interchangeability of all biosimilar medicinal products approved in the EU. Since its publication, both the EMA and National Competent Authorities (NCAs) in EU Member States have received questions about the statement which the new document is intended to address.

For example, the Q&A document clarifies that biosimilar substitution policies, including policies any potential automatic substitution of biosimilars, remain the purview of the Member States:

Q3: Does the joint EMA-HMA statement on interchangeability of biosimilars mean that switching to or between biosimilars are allowed in my country?

A3: No, EMA does not regulate prescribing practices or issue clinical guidance; these matters fall under national remit and are issued by the relevant bodies in each Member State. The statement on interchangeability of biosimilars is a general statement on the scientific principle highlighting that biosimilars can be used interchangeably and detailing the scientific references supporting this position. The statement is meant to advise those Member States that want to allow for biosimilar prescribing, including any national decision on switching and/or (automatic) substitution. However, each Member State will decide on how this is applied in their territories, e.g. which biological medicines are available for prescribing in their country and whether automatic substitution with biosimilars is allowed at pharmacy level.

Read the EMA/HMA Joint Statement here.

Read the full Q&A statement here.

In January, drug manufacturers Eli Lilly and AbbVie announced they have left the UK’s voluntary scheme for branded medicines pricing and access (VPAS), a long-standing agreement between the Government, NHS and medicine manufacturers designed to limit the cost of drugs for the health service. But these policies may jeopardize patients’ access to new treatments over time. As explained in the Telegraph:

The scheme caps the health service’s branded medicines bill, meaning that all drug manufacturers face a charge if the bill rises more than two per cent annually. The cost of that charge has risen rapidly in recent years as demand for NHS treatment has grown. As of Dec 2022, the payback rate was set at 26.5 per cent. Before the pandemic, the rate was about five per cent.

The Association of the British Pharmaceutical Industry (ABPI), the medicines trade body, said the increase puts the UK “out of step” with global competitors, with European countries such as Germany having rates of just nine per cent.

Eli Lilly, which has operated in the UK since the Forties, said that VPAS has “harmed innovation” in the UK and will turn it into a “global outlier”. Laura Steele, Eli Lilly’s president and general manager for northern Europe, said: “We simply cannot stay signed up to a scheme which has such a punishing impact on innovation.

Todd Manning, the general manager of AbbVie UK – which is currently manufacturing innovative drugs for lung cancer and inflammatory bowel disease – said that its decision to leave VPAS was not taken lightly and that the revenue clawbacks had a “demonstrable impact on our ability to operate sustainably in the UK”. He added: “Without a positive signal that the future scheme will deliver more reasonable rates, I fear it will be increasingly difficult to advocate for the UK and what I believe is our shared ambition of securing investment, jobs and, ultimately, delivering improved health outcomes for UK patients.”

Dr Richard Torbett, the chief executive at the ABPI, said “We have already seen the UK lose almost half of its global share of R&D over the past decade. For this trend to be reversed, we must develop a more internationally competitive scheme with the Government that can genuinely support the life sciences vision.”

The number of clinical trials initiated in the UK each year has fallen by more than two-fifths between 2017 and 2021. ABPI and its members said that the level will have further impacts on patients’ access to new and innovative drugs.

Read the full Telegraph article here.

Both Diabetes Canada and Crohn’s and Colitis Canada have stated they disagree with the changes, saying medication switches need to be made in conversation with the patients.

Some residents in other provinces that made the switch have reported the new drugs not being effective, while others were concerned about the resurfacing of painful flare ups they had before being put on their current medication.

Arthritis patient Megan MacLeod said she is frustrated the government is focused more “on their collective wallet than what this is going to do to people who are living with these kinds of conditions.”

Read the CBC article here.

On January 11th, the U.S. Department of Health and Human Services (HHS) announced its plan for Medicare to begin to negotiate prices for drugs as part of the recently-passed Inflation Reduction Act. As USA Today reports:

• By Sept. 1, Medicare will announce 10 retail drugs to negotiate maximum prices.
• In 2024, the agency will bargain with drug manufacturers and publish prices by September for prices that will take effect Jan. 1, 2026.
• Over the following two years, the federal health program will target another 30 retail and physician-administered drugs.
• Beginning in 2029, Medicare will negotiate prices on up to 20 drugs each year.
• Retail drugs are eligible only after they have been on the market for nine years without a competing generic version.
• Physician-administered drugs will have 13 years before being subject to negotiation.

The Centers for Medicare and Medicaid Services (CMS) released a 2-page document providing a more detailed timeline, which may be read here. 

Read USA Today’s coverage of the announcement here. 

In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:

Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar products. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
The paper was published in GaBI Journal, Volume 11, Year 2022, Issue 3.

Read the full paper online here. 

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

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. The latest module is entitled “PBMs and Payer Practices” and is presented by ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR.

In this module Dr. Feldman explains unique features of the U.S. drug distribution system, with an emphasis on payer and pharmaceutical benefit manager (PBM) practices regarding biologic medicines and biosimilars. The bifurcated U.S. system (provider-administered vs. self-administered/pharmacy side) is examined in detail and the differences in these two sub-markets are highlighted: in particular, the degree to which savings can be achieved, and the role played by middlemen and manufacturer rebates in driving up rather than lowering costs. Utilization management tools used by payers (including non-medical switching and step therapy) are described, as are proposed regulations and legislation to restrict such practices.

1. Discuss the role of pharmaceutical benefit managers (PBMs) in the U.S. drug distribution system
2. Explain the effects of competition on drug pricing under provider-administered and patient-administered drugs.
3. Identify several utilization management techniques used by PBMs to influence which medicine the patient receives.
4. Describe concerns that patients and physicians have regarding these PBM practices.
5. Discuss potential legislative approaches under consideration to address concerns with these PBM practices.

View all available modules of the ASBM/OSU Biosimilars Course here. 

In December, the Generics and Biosimilar Initiative (GaBI) published a whitepaper entitled “US prescribers’ attitudes and perceptions about biosimilars”, based on the findings from ASBM’s survey of 401 U.S. physicians fielded in late 2021. The paper was authored by ASBM’s Chairman Ralph McKibbin, MD, FACP, FACG, AGAF; and Executive Director Michael S. Reilly, Esq. The survey examines physician attitudes toward a wide variety of biosimilar policy issues including approval standards, non-medical switching, interchangeability, and reimbursement practices. While U.S. physicians were highly confident in the safety and efficacy of biosimilars, the survey revealed that maintaining control over treatment choices- including the ability to prevent substitution by a third party- was extremely important to the respondents. From the abstract:

Most physicians are comfortable prescribing biosimilars and comfortable switching stable patients to biosimilar product. Over half of physicians are more likely to prescribe biosimilars with interchangeable status and they are comfortable with pharmacy level substitution of these products. However, the majority want to keep the authority to prevent pharmacy level substitution if they specify so. When it came to switching patients to a biosimilar for non-medical reasons, the majority were comfortable doing this but fewer than half were comfortable with third party switching. In addition, most physicians favored a scenario where multiple products, including innovator and biosimilars are reimbursed, and biosimilars may be encouraged for new patients with no automatic substitution permitted.
The paper was published in GaBI Journal, Volume 11, Year 2022, Issue 3.

Read the full paper online here. 

In December, the Ontario government announced that it would follow other Canadian provinces including British Columbia, Alberta, Quebec and require mandatory switching to biosimilars.  a mandatory switching in 2020, but implementation was delayed due to the COVID-19 pandemic. A nine-month transition period will begin March 31st. From the government’s announcement:
Ontarians receiving coverage under the ODB program for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan®, will be required to transition to the biosimilar version by December 29, 2023. During the transition period between March 31 and December 29, 2023, patients are encouraged to discuss a transition plan with their health care provider through in-person, telephone or virtual visits. Exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider.

While the Ontario announcement justifies the policy by citing 15 years of successful use of biosimilars in Europe, it is important to note that in nearly every European country physicians retain free choice between multiple reimbursed products and forced substitution is rare. A 2017 survey of 403 Canadian physicians revealed that Canadian physicians are generally opposed to forced substitution: 

• 64% were not comfortable with a third party switching a patient’s medicine for non-medical reasons, as would occur under the Ontario policy. 28% were somewhat comfortable, and only 6% were completely comfortable.
• 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.
• 79% considered it “very important” or “critical” to have the authority to designate on a prescription for a biologic medicine “Dispense as Written” or “Do Not Substitute”.

Read the announcement from the Ontario government here. 

On December 13th, the US Food and Drug Administration (FDA) approved its eighth biosimilar for Humira (adalimumab): Idacio (adalimumab-aacf).

Idacio is a tumor necrosis factor (TNF) blocker that blocks the production of TNF-alpha to reduce inflammation in the joints and skin. Idacio is indicated to treat a range of autoimmune disorders such as ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis. It is expected to launch in the US in July 2023 as self-administered prefilled syringes and self-administered prefilled pens (autoinjectors).

The approval brings the total number of biosimilars approved in the U.S. to forty.

Read more about the approval here.

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

The 2023 Treatment Choice Summit

Washington, DC – January 31, 2023

Festival of Biologics 2022 USA

San Diego, CA – March 20-22, 2023

WHO 76th INN Consultation

Geneva, Switzerland – March 28, 2023

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

• 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
• 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
• Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.

View Professor Schneider’s Festival of Biologics presentation here.

View ASBM’s Festival of Biologics poster here. 

In November, ASBM Chairman Ralph McKibbin, MD FACP FACG AGAF was named to the American College of Gastroenterology’s (ACG’s) Board of Governors. From ACG’s announcement:

Dr. Ralph D McKibbin has been selected to serve as a Governor of the American College of Gastroenterology. He will represent the members of Western Pennsylvania. The Board of Governors acts as a two-way conduit between College leadership and the membership at large. The ACG Governors also act as representatives on important issues facing gastroenterologists and organized medicine at large at both the national and state levels with advocacy activities occurring with Federal and State bodies as well as professional associations on regional, state and national levels.

A practicing gastroenterologist in Altoona, PA, Dr. McKibbin has served as ASBM Chairman since September 2021. He is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC).

More information about the ACG Board of Governors may be found at the ACG website here. (registration required).

On November 9th, two ASBM Steering Committee members participated in the 2022 Generics and Biosimilars Conference (GRx+Biosims), held in Bethesda, MD. Andrew Spiegel of the Global Colon Cancer Association and Gavin Clingham of the Alliance for Patient Access both shared patient perspectives on biosimilars at a panel entitled “The Patient Voice in Drug Development”.

The purpose of the discussion was to hear from both the FDA and patient advocacy groups involved in this space about how the patient voice and experience can be harnessed to speed the development of and access to generics and biosimilars, and the tools that can be used to improve the patient perspective in this process.

Other speakers included representatives from the FDA’s Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER): Sarah Ibrahim, PhD, PharmD, Associate Director for Global Regulatory Affairs at the Office of Generic Drugs at CDER; and Partha Roy, PhD, Director of the Office of Bioequivalence at CDER.

The conference was sponsored by the Biosimilars Council, a division of the Association for Accessible Medicines. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.

Read more about the 2022 GRx+Biosims Conference here.

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment 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.

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. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

Read ASBM’s comment letter here.

Learn more about the approval here. 

From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland.

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. Findings included:

• 71% of respondents considered it highly important that payers (public and private) should reimburse multiple products in a given class- including originator and biosimilars.
• 81% believe their patients would be best served under the biosimilar access scenario popular throughout most of Western Europe- in which biosimilars and originator products are both reimbursed, biosimilars may be encouraged for new patients, but automatic or pharmacy-level substitution is not permitted.
• Only 8% supported the access scenario implemented by several Canadian provinces, in which only a preferred, government-chosen product is reimbursed and to which both new and stable patients must be switched. 11% were unsure.

ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, gave the Day 3 opening keynote address on the topic: “Protecting the future of biosimilars”. Mr. Spiegel also chaired a panel entitled “Biosimilar Communication and Patient Engagement Strategies – How Can Stakeholders Work Together to Effectively Communicate About Biosimilars in the Clinic?” on which Professor Schneider appeared as a panelist.

View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here.

Read the GaBI Journal report of the webinar here.

View Professor Schneider’s Festival of Biologics presentation here.

View ASBM’s Festival of Biologics poster here. 

In November, ASBM Chairman Ralph McKibbin, MD FACP FACG AGAF was named to the American College of Gastroenterology’s (ACG’s) Board of Governors. From ACG’s announcement:

Dr. Ralph D McKibbin has been selected to serve as a Governor of the American College of Gastroenterology. He will represent the members of Western Pennsylvania. The Board of Governors acts as a two-way conduit between College leadership and the membership at large. The ACG Governors also act as representatives on important issues facing gastroenterologists and organized medicine at large at both the national and state levels with advocacy activities occurring with Federal and State bodies as well as professional associations on regional, state and national levels.

A practicing gastroenterologist in Altoona, PA, Dr. McKibbin has served as ASBM Chairman since September 2021. He is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC).

More information about the ACG Board of Governors may be found at the ACG website here. (registration required).

On November 9th, two ASBM Steering Committee members participated in the 2022 Generics and Biosimilars Conference (GRx+Biosims), held in Bethesda, MD. Andrew Spiegel of the Global Colon Cancer Association and Gavin Clingham of the Alliance for Patient Access both shared patient perspectives on biosimilars at a panel entitled “The Patient Voice in Drug Development”.

The purpose of the discussion was to hear from both the FDA and patient advocacy groups involved in this space about how the patient voice and experience can be harnessed to speed the development of and access to generics and biosimilars, and the tools that can be used to improve the patient perspective in this process.

Other speakers included representatives from the FDA’s Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER): Sarah Ibrahim, PhD, PharmD, Associate Director for Global Regulatory Affairs at the Office of Generic Drugs at CDER; and Partha Roy, PhD, Director of the Office of Bioequivalence at CDER.

The conference was sponsored by the Biosimilars Council, a division of the Association for Accessible Medicines. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.

Read more about the 2022 GRx+Biosims Conference here.

On November 3rd, ASBM submitted comments to the Minnesota Department of Commerce on two mandated health benefit bills, as part of a public comment period.

The first proposal was SF 990, mandating coverage of multiple biologic products, which ASBM opposed. ASBM had previously led patient advocacy organization opposition to the measure last summer. From the comment 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.

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. For this reason, we strongly urge the Department of Commerce to oppose SF 990.

ASBM’s comments offered support for the second bill, HF 4899, which would mandate health plan coverage for biomarker testing: 

Patients with serious and chronic conditions such as cancer or rheumatoid arthritis must often try multiple treatments before finding the one that works best for them. Biomarker testing helps ensure that patients receive the right treatment for them in a timely manner.

But health care coverage for biomarker testing too often fails to keep pace with these scientific advancements. HF 4899 will work to remedy this by requiring health plans in Minnesota to cover biomarker testing when supported by medical and scientific evidence, including nationally-recognized clinical practice guidelines and FDA approval.

Timely access to appropriate biomarker testing helps achieve better health outcomes, improves quality of life for patients, and reduces costs to our health system. For these reasons, we strongly urge the Department of Commerce to support HF4899.

Read ASBM’s comment letter here.

Learn more about the approval here.