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.
Our Perspective
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 Leads Three Panel Discussions at Festival of Biologics USA 2021
From March 29th-31st ASBM representatives led three panel discussions at the World Biosimilar Congress USA 2021, part of the annual Festival of Biologics USA. Typically held in San Diego, CA, the event was conducted virtually this year due the COVID-19 pandemic.
On March 29th, ASBM Steering Committee Member Andrew Spiegel moderated a keynote panel discussion entitled “Biosimilar Regulatory Reform”. Panelists included Eva Temkin, Acting Director for Policy at the U.S. Food and Drug Administration’s Office of Therapeutic Biologics and Biosimilars from 2019-2021 and Leah Christl, former director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND).
Panelists shared their thoughts on how clinical biosimilar development may evolve in the future, both in the US and in Europe. Also discussed were challenges in developing orphan biosimilar medicines including what is being done at regulatory level to encourage their development.
On March 31st, Spiegel moderated a second panel, entitled “Biosimilar Uptake and Progress from the Healthcare Perspective”. Panelists included representatives from Hematology/Oncology departments at Boston Medical Center and Highland Hospital, and a representative from the pharmacy contracting company Vizient.
The speed of biosimilar uptake was a key topic of the discussion. Recently approved rituximab, trastuzumab, and bevacizumab oncology biosimilars, experienced much faster uptake than earlier biosimilars (filgrastim, peg-filgrastim, erythropoietin alpha and infliximab). Mr. Spiegel asked panelists whether they thought the adalimumab and etanercept biosimilars due in 2023 were likely to experience similarly speedy uptake. The Vizient panelist suggested uptake might be slower. Gastroenterologists and rheumatologists have been less supportive of biosimilars than oncologists in his view, citing slower uptake among infliximab biosimilars.
On March 31st, ASBM Advisory Board Chair Philip Schneider moderated the Closing Keynote Panel that concluded the conference. The topic of the panel was “Harnessing influence to change biosimilar policies: current programs and ideas for the future.” Panelists included representatives from the ERISA Industry Committee (ERIC); Boston Medical Center; Ponchartrain Cancer Center; Employers Health; and Biocon.
Key points raised during the panel were the importance of transparency in the payment process- particularly among payers and the insurance companies; the role of competition and biosimilars in the marketplace to control the costs of expensive biologics, the need to align incentives among employers and providers, and the need for curricula on biologic in the education of health care professionals.
Learn more about the Festival of Biologics USA 2021 and view the full program agenda here. |
| ASBM to Present Poster at DIA Global Annual Meeting 2021
On March 12th, the Program Committee for the DIA Global Annual Meeting 2021 informed ASBM that our poster abstract “A Review of Problems with Pharmacovigilance Programs and Biologics” has been accepted for an ePoster presentation. The abstract was authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider.
The poster will examine a variety of published literature on global pharmacovigilance of biologic medicines, with a focus on difficulties in accurately identifying biologics at the product level in Adverse Drug Reaction (ADR) reports and self reporting surveys (SRS). For example, in a 2019 analysis of European ADR reports for infliximab in 2018, 35% did not provide a brand name, despite this being required by EU law since 2012.
Lack of a consistent international standard for biologic naming was idenitifed as a barrier to biosimilar adoption in a recent WHO-sponsored 20-country study. “There is still no consensus among countries on the naming and labeling of biosimilars,” its authors observed, “and the WHO does not provide specific nomenclature for biosimilars.”
In 2014 the WHO’s INN Expert Group proposed a voluntary naming standard to promote accurate biologic identification. But despite early support for the standard from many countries including the US, Canada, Australia, and Japan, it has not yet been made available to national regulatory authorities.
DIA 2021 runs from June 27-July 1, 2021. EPosters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2021.
Learn more about DIA 2021 and see the draft Program Agenda here.
|
| Study Questions Value of In Vivo Animal Studies for Biosimilars
A new study in the journal Regulatory Toxicology and Clinical Pharmacology suggests in vivo animal studies of biosimilars “have added little evidence to provide clinically relevant information for biosimilar development.” The authors reviewed animal study findings from development of eight biosimilars candidates. Among their findings:
The study will be published in the print edition of the journal Regulatory Toxicology and Pharmacology Volume 122, June 2021.
Read it online here.
|
| Senate Passes Biosimilar Education Bill
On March 3rd, the US Senate unanimously passed the Advancing Education on Biosimilars Act (S 1681). The bill directs the FDA to improve education on biosimilars with the goal of increasing uptake.
The bill would require FDA to create a biosimilars education website explaining key statutory and regulatory terms associated with biosimilars, such as “interchangeability”. The website would be targeted at health care providers/
The Senate version of the bill was introduced in May 2019 and was voted on successfully in December 2020, but required a new vote this year. A House version of the bill (HR 4400) was introduced in September 2019 and referred to the Subcommittee on Health.
Read more about the Advancing Education on Biosimilars Act (S 1681) here.
|
| UPCOMING EVENTS
Biologics Europe Online Virtual – April 26-27, 2021
DIA Global 2021 Annual Meeting Virtual – June 27- July 1, 2020
World Biosimilar Congress Europe 2021 Basel, Switzerland – November 9-11, 2021
|
