Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
|ASBM’s Feldman and Reilly Present at Treatment Choice Summit
On January 31st, ASBM’s Immediate Past Chair Madelaine Feldman, MD, FACR and Executive Director Michael Reilly participated in the 2023 Treatment Choice Summit, held in Washington, DC.
Dr. Feldman moderated the first panel discussion, Patient and Provider Perspectives on the Impact of Treatment Choice. The purpose of the discussion was to identify barriers to treatment choice and how these impact patients, their out-of-pocket costs, and the patient-physician relationship.
Mr. Reilly appeared on a second panel, entitled Recent Policy Initiatives to Protect Treatment Choice, which examined ways in which effective advocacy can protect treatment choice. Mr. Reilly emphasized the importance to physicians of maintaining control over treatment choice, citing ASBM’s extensive research into physician perspectives on non-medical switching:
“ASBM has surveyed physicians around the world and we have consistently seen that while they are confident in biosimilars they strongly believe that treatment decisions should be made by physicians in consultation with the patient – not by a third party for cost reasons.”
A 2021 ASBM survey of 401 U.S. physicians found that the 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; and 67% consider it “very important” or “critical” that they are able to prevent a substitution they feel is inappropriate.
Read a whitepaper on the U.S. physician survey here.
|First Adalimumab Biosimilar Launches in U.S.
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.
|EMA Issues Q&A Document Clarifying Previous Statement on Interchangeability of EU Biosimilars
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.
|Cautionary Lessons for US Policymakers as Innovation, Access Jeopardized by UK Pricing Controls
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.
|Saskatchewan Patients Concerned as Forced Switching Approaches
A January 22nd article from the Canadian Broadcasting Company (CBC) details some of the concerns Saskatchewan patients have about the Province’s forced biosimilar switching policy, announced in October 2022. The deadline to switch from physician-chosen to government-chosen medicine is April 30th. From the article:
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.
|HHS Announces Medicare Drug Price Negotiation Plan
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:
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.
|Reminder: ASBM Members Receive Free Access to OSU’s Biosimilars Course
The Ohio State College of Pharmacy has provided ASBM with access codes for our Members who wish to view the first four modules of the ASBM/OSU College of Pharmacy Biosimilars Course at no charge:
Biosimilars Module 1: Introduction to Biologics and Biosimilars
To request free access to the Biosimilars Course, please email Ray Patnaude here. Access to the three remaining modules in the series will be available in the coming weeks.
|ICYMI: GaBI Journal Publishes Paper on ASBM US Physician Survey
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.
Read the full paper online here.