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.
| Registration Open for June 29th ASBM/GaBI Webinar on Biosimilar Success in Europe and US
On June 29th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host a webinar entitled “KEY FACTORS FOR SUCCESSFUL UPTAKE OF BIOSIMILARS: EUROPE AND THE US: measures taken for improving biosimilar uptake and the potential role of healthcare providers and patients” The online event will run June 29th from 10:00 am – 11:50 am EST. An academic clinician with a specialty in gastroenterology, a pharmacist, a patient advocate, and a market access expert will share their experience with biosimilars, highlighting successes and challenges, their perspectives on prescribing and switching of biosimilars, and measures to increase biosimilar adoption, including the role of physicians and other healthcare providers. Speakers will include:
The discussion will continue at the next webinar on “Non-medical switching of biologicals/biosimilars: Canada, Europe, the US” in July 2022. More information will be available soon.
|
| OSU College of Pharmacy Videos Promote ASBM CE Course on Biosimilars
On May 31st, the Ohio State University College of Pharmacy released a series of promotional videos for its 7-hour continuing education (CE) program on biosimilars.The videos consist of an overview of the educational program featuring all the presenters, as well as a biographical sketch of each presenter.
The program was developed in partnership with ASBM and covers a broad variety of biosimilar topics. The program is fully ACPE-accredited and available to pharmacists nationwide. The course consists of seven modules, of which the first three are currently available. Additional modules will be added in the coming weeks.
The course is presented by the University’s Office of Continuing Professional Development and may be accessed here (registration required).
View the course outline here.
Watch the course overview video here.
Watch the biographical video for Professor Schneider here.
Watch the biographical video for Dr. McKibbin here.
Watch the biographical video for Dr. Feldman here.
Watch the biographical video for Mr. Spiegel here.
|
| FDA Approves 36th Biosimilar, Fifth for Pegfilgrastim
On May 27th, the U.S. FDA approved Fylnetra (pegfilgrastim-pbbk), a biosimilar to pegfilgrastim.
Fylnetra is a leukocyte growth factor, indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Fylnetra is expected to launch sometime during the second half of 2022. Fylnetra is the 36th biosimilar approved by the FDA, and the fifth pegfilgrastim biosimilar approved. Read more about the approval here.
|
| ASBM Sponsors Two-Day Biosimilar Training Program
On May 10-11, ASBM sponsored a two-day Biosimilars Training Program, presented by the Global Colon Cancer Association in partnership with the World Patient Alliance. This live event was open to patients from any disease state and drew hundreds of representatives from patient advocacy organizations worldwide.
Those who were unable to attend the live event on May 10-11 may now watch the sessions on-demand here.
This two-day program educates patients worldwide about biosimilars and equip them with the tools they need to be more effective advocates and help ensure their country’s biosimilar policies work for the patients they represent. Several ASBM representatives led sessions; these included:
Patient Advocacy Toolkit
Access the Biosimilar Training Program and Patient Advocacy Toolkit here.
|
| Bill Would Expand User Fees Programs for Biosimilars
On May 6, H.R. 7667 was introduced in the U.S. House of Representatives that would “amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes”.
Title IV of the package, also known as the “Biosimilar User Fee Amendments of 2022”, deals specifically with biosimilars. Biosimilar user fee programs support the review of biosimilar product applications.
The bill was referred to the House Committee on Energy and Commerce, which voted 30-0 to advance the bill. In a press release, Committee Chairman Frank Pallone, Jr said of the bill:
This legislation would reauthorize FDA’s user fee programs, which are critically important to ensure the agency has the funding it needs so that Americans can continue to trust that the drugs and medical devices they use are safe and effective. This comprehensive package also includes important provisions that will help lower drug costs for the American people by promoting competition for generic drugs. Read the House Energy and Commerce’ Committee’s press release on the bill here.
Read the text of H.R. 7667 here.
|
| Canadian Medical Association Urges Caution on Biosimilar Policies
The forced-switching policies of some Canadian provinces result in large increases in uptake, yet remain controversial, according to an analysis of these policies in the Canadian Medical Association Journal. From the article:
The use of switching policies — when biosimilars are not considered interchangeable or may have garnered additional indications indirectly — is controversial. A joint position statement from the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada supported the use of biosimilar infliximab in treatment-naive patients but recommended against switching from treatment with originator drugs among those who were already stable.
In contrast, the Canadian Rheumatology Association and Canadian Spondylitis Association generally support biosimilar substitution that involves informed consent and the option to switch back to the reference biologic.
It is important to emphasize that division remains, concerns regarding biosimilar switching persist, and there are real impacts on patient and provider autonomy as a result of biosimilar switching.
The authors of the analysis conclude that “salient concerns among patients and providers persist, and policy-makers should proceed with caution as further evaluation is necessary.”
Read the full article here.
|
| ICYMI: ASBM to Present U.S. Physician Survey Data at DIA Global Annual Meeting
On June 20th, ASBM Chairman Ralph McKibbin, MD will present a poster entitled “U.S. Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” at the 2022 DIA Global Annual Meeting in Chicago, IL. The poster is based on the findings of ASBM’s September 2021 survey of 401 U.S. physicians.
Dr. McKibbin will present the survey findings on June 20th between 12:00-1:15pm at the professional poster exhibit area at the McCormick Center West Convention Hall. The meeting will run from June 19th through the 23rd.
Read more about the topics covered by the survey here.
Watch a video preview some of the findings here.
Register for the 2022 DIA Global Annual Meeting here.
|
| UPCOMING EVENTS
BIO International Convention San Diego, CA – June 13-16, 2022
DIA Global Annual Meeting 2022 Chicago, Illinois – June 19-23, 2022
ASBM-GaBI Webinar: Virtual (Register here) – June 29, 2022
World Drug Safety Congress Boston, MA – October 4-5, 2022
WHO 75th INN Consultation Geneva, Switzerland – October 18, 2022
Festival of Biologics Europe 2022 Basel, Switzerland – November 2-4, 2022 |
