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.
|CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment
On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022. The IRA grants new authority for CMS to negotiate “maximum fair prices” (MFPs) for certain high expenditure, single source drugs and biological products. From the memo:
This initial guidance describes how CMS intends to implement the Negotiation Program for initial price applicability year 2026 (January 1, 2026 to December 31, 2026), and specifies the requirements that will be applicable to manufacturers of Medicare Part D drugs that are selected for negotiation and the procedures that may be applicable to manufacturers of Medicare Part D drugs, Medicare Part D plans (both Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug Plans (MA-PDs)), and providers and suppliers (including retail pharmacies) that furnish Medicare Part D drugs.
The memo notes that CMS is not following the typical notice-and-comment requirements of the Administrative Procedure Act or the Medicare statute, citing both legislative direction and its own assessment: “CMS finds that notice and public procedure on this guidance would be impracticable, unnecessary, and contrary to the public interest”.
While some of the guidance is being issued as final, the announcement solicits offers just 30 days for concerned parties to comment on other portions of the guidance:
“To undertake such a major change to the Medicare program outside of the notice-and-comment period is highly unusual and runs counter to long-established procedures”, says ASBM Executive Director Michael Reilly, who served for 6 years in the Office of the Secretary at the Department of Health and Human Services (HHS) as Medicare Part D was being developed and implemented. “Unfortunately, rushed policy made absent stakeholder input rarely results in good policy”.
|ASBM Presents at WHO 76th INN Consultation
On March 28th, ASBM participated in the World Health Organization’s 76th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the twentieth INN Consultation in which ASBM has participated.
ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.
The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.
The recently-published Executive Summary from the 75th INN Consultation, at which ASBM presented in October 2022, summarizes ASBM’s position regarding the value of distinct biologic nomenclature:
One significant challenge to efficient global cooperation is the lack of harmonization. Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Indeed, surveys show that there remains a clear need for harmonization of distinguishable names with only two-thirds of ADR reports recording the brand name of the biologic, and even fewer recording the non-proprietary name. Other surveys show that only a small proportion of physicians record the non-proprietary name and extremely few use an officially recommended drug code number.
In conclusion, the ASBM urged the WHO to make a voluntary distinct naming standard available to facilitate international cooperation and harmonization. This will help speed approval, increasing access to biosimilars while promoting safety and building confidence through strong post-market monitoring.
Read the WHO’s summary of the 75th INN Consultation here.
|Biden Administration to Develop Framework to Implement “March-In Rights”
On March 21st, the U.S. Department of Health and Human Services (HHS), with the U.S. Department of Commerce, announced the formation of an working group to develop an implementation framework for the government to exercise ‘march-in” rights as a tool to lower drug prices.
The announcement indicates a “whole-of-government approach” will be used to review its march-in authority as laid out in the Bayh-Dole Act, which promotes commercialization of research results, maximizes the potential for federally-funded technologies to become products, and serves the broader interest of the American public. From the press release:
“The Biden-Harris Administration is committed to increasing access to health care and lowering costs. And march-in authority is a powerful tool designed to ensure that the benefits of the American taxpayer’s investment in research and development are reasonably accessible to the public,” said HHS Secretary Xavier Becerra. “We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward.”
Under the Bayh-Dole Act, adopted in 1980, the government can promote the commercialization and public availability of even partially government-funded inventions. But when it comes to using the law to drop the price of a drug under patent protection, the move has never been successful.
In another letter dated the same day, HHS, which oversees the National Institutes of Health (NIH) declined to use “march-in” rights to lower the price of Astellas’ and Pfizer’s prostate cancer drug Xtandi (enzalutamide).
From the letter:
|Upcoming ASBM/GaBI Webinar to Focus on IRA’s Price Negotiation Provisions
On May 3rd, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences that may result from the implementation of IRA provisions regarding biologic and biosimilar medicines.
The first webinar, tentatively scheduled for May 3rd, will focus on the IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid to negotiate prices of certain costly drugs, including many biologic medicines. Webinar presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and on the practice of healthcare professionals including physicians and pharmacists.
More information will be available in the coming weeks.
|ASBM Chair Advocates for PBM Reform on Capitol Hill
On March 5th-6th, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF participated in the 33rd annual Digestive Disease National Coalition public policy forum in Washington, DC March 5th and 6th.
The advocacy conference brought together patient advocates, health care providers, and industry representatives from the major national voluntary and professional societies concerned with digestive diseases. This year’s theme was “Improving Patient Care.”
Live panelists included Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition at the National Institute for Diabetes, Digestive and Kidney Diseases and Brenda Rodriguez, Senior Engagement Officer at the Patient-Centered Outcomes Research Institute. Both highlighted the need for focusing on patient outcomes in this age of rising inflation and medication costs.
ASBM Chairman Ralph McKibbin MD; DDNC President Carrol Koscheski; and Brad Conway, VP of Legislative Affairs and Advocacy for the American College of Gastroenterology were among the physicians who met with lawmakers on PBM reform and other issues.
Dr. McKibbin, along with DDNC leadership, met with Representative Buddy Carter of Georgia – a champion for pharmacy benefit manager (PBM) reform – to discuss the need legislation in this area. Rep. Carter is a pharmacist who ran a chain of local pharmacies prior to becoming a congressional representative and is well informed on the issues. He has produced an educational booklet on the subject entitled “Pulling Back the Curtain on PBMs: A Path Towards Affordable Prescription Drugs”.
|FDA Approves High-Concentration Adalimumab Biosimilar
On March 21st, the FDA approved a citrate-free, high-concentration formulation (HCF) of the adalimumab biosimilar Hyrimoz (adalimumab-adaz) manufactured by Sandoz.
The injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.
Sandoz intends to launch the biosimilar in the United States on July 1, 2023.
The first biosimilar for Humira, Amejevita (adalimumab-atto) was launched in February by Amgen and is expected to be the only adalimumab biosimilar on the market until July, although several more are expected to launch this year.
|FDA Releases New Biosimilars Education Materials for Patients
On March 21st, the U.S. Food and Drug Administration (FDA) released three new educational resources about biosimilars, targeted at patients:
The materials answer basic questions that patients might have about biologic medicines and biosimilars, including:
For more information about biosimilars and additional resources for patients, visit the FDA’s “Biosimilar Basics for Patients” educational site here.
ASBM/GaBI IRA Webinar
May 3, 2023
Digestive Disease Week 2023
Chicago, IL – June 2-6, 2023
DIA Global Annual Meeting
Boston, MA – June 25-29, 2023