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 Urges Reform on Copay Accumulator Adjustments
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.
|ASBM’s Madelaine Feldman Discusses Role of PBMs in Increasing Drug Prices
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:
Learn more about Center for Biosimilars webinar here.
Read Dr. Feldman’s testimony about PBM practices here.
|ASBM to Participate in Festival of Biologics USA 2022
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.
|ICYMI: ASBM Featured in WHO Executive Summary of 73rd INN
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.
|FDA Presents 1-hr Educational Course on Interchangeable Biosimilars
On January 25th, CDER’s Office of Communication, Division of Drug Information (DDI) hosted a webinar entitled: FDA Drug Topics: Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources.
This webinar provided an intermediate overview of the scientific and regulatory basis for the biosimilar and interchangeable biosimilar approval pathway. The webinar built on past biosimilar webinars and further explores the science of biological molecules, including size, complexity, and inherent variation. In addition, FDA officials discussed the use of these products, including labeling, terminology, and pharmacy substitution.
The presenters reviewed case studies to highlight the data that can support biosimilarity and interchangeability. This webinar also demonstrated the functionality of resources available to health care professionals such as the Purple Book Database.
View the FDA presentation slides here.
|UPCOMING ASBM EVENTS
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