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 Paper is GaBI Journal’s Most-Read Biosimilars Article of 2020
According to the editors of the Journal of the Generics and Biosimilar Initiative (GaBI Journal), the most-viewed biosimilars article of 2020 was the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe”, co-authored by ASBM’s Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The article was published online in February 2020 and in Issue 2 of GaBI Journal’s print edition.
The paper examined biosimilar substitution policies across Europe, looking for commonalities among them which led to successful and sustainable biosimilar markets. The paper found that across Europe, biosimilars have:
While the policies by which this has been achieved vary somewhat between countries, the paper reveals that all major European markets share the following features:
Read the whitepaper here.
|WHO Survey: Lack of International Naming System is Barrier to Biosimilar Adoption
The World Health Organization (WHO) recently released the results of a 20-country survey which identified barriers to biosimilar adoption, the Center for Biosimilars reports. Entitiled “Regulatory challenges with biosimilars: an update from 20 countries”, the survey was a follow-up to one conducted ten years prior. While most of the issues identified in the earlier survey have been resolved, the authors report, a few remain including the lack of a consistent international standard for biologic naming. “There is still no consensus among countries on the naming and labeling of biosimilars,” they observe, and the WHO does not provide specific nomenclature for biosimilars.
Some countries including Canada and those in Europe, use the brand name and international nonproprietary name (INN) that latter of which is shared between the reference biologic and all its biosimilars. Other countries, including the United States and Japan use a suffix or other identifier as part of the name.
The authors stressed that naming and labeling are important for good pharmacovigilance, which they call “essential for establishing the safety and efficacy of interchangeability of biosimilars.” There are concerns, they say, about “prescription mix‐ups, unintentional switching, and questions on traceability.” To address these concerns, the authors recommended biosimilars be clearly identifiable, using a unique brand name with the international proprietary name, and the lot number be provided.
Following years of study on the issue including findings from the first 20-country survey, in 2014 the WHO’s INN Expert Group in fact proposed a voluntary naming standard which would address these concerns.
Under the proposed system, all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ, tied to the marketing authorization holder (MAH). Advantages of such a system include increased transparency, decreased likelihood of inadvertent or inappropriate substitution, improved traceability including more accurate attribution of adverse events to the correct product, and increased manufacturer accountability for their products.
While initially recieving strong support from many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In the absence of WHO making this system available, in 2015 the FDA adopted its own BQ-like suffix system.
In 2018, Australia adopted the European approach citing lack of WHO progress on implementation of the BQ system. Similarly, until 2019 Health Canada was in conversations with FDA about harmonizing distinct nomenclature systems regionally, but ultimately went with the brand+INN approach used in Europe, again citing lack of WHO action on distinct naming as a reason. However, both Canada and Australia have expressed their willingness to harmonize with the WHO standard were it to be made available.
Learn more about the BQ proposal here.
Read a summary of the paper’s findings here.
Read the paper here.
FDA Approves 29th Biosimilar, Third for Rituximab
Read more about the successes FDA’s of the biosimilar program here.
Rianbi (rituximab-arrx) is indicated to treat adult patients with non-Hogkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
Rianbi (rituximab-arrx) will launch in January 2021. According to the manufacturer, its wholesale acquisition cost (WAC) will be 23.7% lower than the originator, 15.2% lower than Truximab (rituximab-abbs) and comparable to that of Ruxience (rituximab-pvvr). At launch its average sale price (ASP) will be 16.7% lower than the originator.
Learn more about the approval here.
Read the label/packaging insert for Rianbi (rituximab-arrx) here.
|ASBM Presents to Rheumatologists in Saudi Arabia, Kuwait, Iraq
On December 9th, ASBM Advisory Board Chair Philip Schneider presented virtually to the Saudi Society for Rheumatology. The presentation was carried live to gatherings of rheumatologists in Riyadh, Saudi Arabia; Kuwait City, Kuwait; and Baghdad, Iraq.
Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and co-authored by Reilly and Schneider.
The paper examined biosimilar substitution policies across Europe, identifying factors which led to their successful and sustainable biosimilar markets.
The analysis identified six principles the authors refer to as the “Gold Standard”:
The paper also identified three “Must-Haves” for a sustainable biosimilar market:
Read the whitepaper here.
|Reminder: FDA Accepting Comments on Draft Guidance on Biosimilarity and Interchangeability
On November 19th, the US Food and Drug Administration (FDA) issued new Draft Guidance entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.
When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
ASCO Gastrointestinal Cancers Symposium
Virtual – January 15-17, 2021
DIA Latin America Regulatory Conference
Virtual – February 22-23, 2021
World Biosimilar Congress USA 2021
Virtual – March 29-31, 2021
WHO 72nd INN Consultation
Geneva, Switzerland – April 12, 2021