Who We Are
The Alliance for Safe Biologic Medicines is an organization composed 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 ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
For media inquiries please contact: michael@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 971 – 1700
Follow Us
Twitter: @SafeBiologics
Facebook
LinkedIn
YouTube
|
|
|
|
Ohio Biosimilar Substitution Bill Progresses
On November 30th, HB 505 was passed unanimously by the Ohio Senate Health and Human Services Committee (11-0).
The bill passed the House unanimously (96-0) May 11th, the day after ASBM held an educational forum at Ohio State University’s College of Pharmacy and Medicine in Columbus, Ohio, led by ASBM Advisory Board Chair Philip Schneider, who spent 30 years on the school’s faculty and who testified in support of HB 505 on April 20th. The bill’s sponsor, Rep. Stephen Huffman, was in attendance and answered questions about the bill.
HB 505 would permit a pharmacist to substitute an interchangeable biosimilar once approved by the FDA, provided the pharmacist communicates which product – the originator or the biosimilar- was dispensed to the patient. 25 states and Puerto Rico have passed similar laws over the past three years.
The bill now heads to the full Senate.
|
|
ASBM Member Represents Patients at FDA Listening Session
On November 18th, FDA Commissioner Dr. Robert Califf held an informal listening session for FDA officials with patients and physicians at the FDA’s White Oak campus in Silver Spring, MD. Roughly 30 people were in attendance.
ASBM Steering Committee member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, attended the meeting to speak on behalf of patients’ interests.
Biosimilar policy was a area of concern of many of the speakers. Mr. Spiegel emphasized the enthusiasm for biosimilars among the patient community, and praised the FDA’s support for clear naming of biosimilars, but urged the agency to support greater transparency in biosimilar approval and labeling.
“Patients want biosimilars, but we also want our physicians to have the information they need to give us informed advice when making treatment decisions.”
Read Mr. Spiegel’s full remarks here.
|
|
ASBM Brings Provider, Patient Voices to World Biosimilar Congress: Europe 2016
On November 15th, ASBM Advisory Board Chair Philip Schneider, MS, FASHP, participated in a moderated discussion about biosimilar naming policy at the World Biosimilar Congress: Europe 2016 conference in Basel, Switzerland.
Dr. Schneider, a past president of the American Society of Health-system Pharmacists (ASHP) and current board member of the International Pharmaceutical Federation (FIP) represented the health care provider community in the discussion. He emphasized the importance to providers of clear product identification, citing data from ASBM’s surveys of providers in 12 countries, which show broad support for distinct naming of all biologics, including biosimilars. Dr. Schneider also discussed how ASBM has worked with the WHO as it modifies its system of international nonptoprietary names (INN) to clearly differentiate biosimilars both from their reference products and from one another.
Andrew Spiegel, Executive Director ASBM member group Global Colon Cancer Association, also presented at the conference, providing the patient perspective on biosimilars. Mr. Spiegel expressed enthusiasm for the new treatment options and lower costs biosimilars will bring, but cautioned that patients and their physicians should remain in ultimate control of treatment decisions, rather than a third party focused on economic goals such as greater profits or cutting spending. Mr. Spiegel characterized this “Non-Medical Switching” of a patient to a biosimilar as a major concern for patients globally, and played a testimonial video from Kathleen Arntsen, President of of Lupus an Allied Diseases Association (LADA), another ASBM member.
Dr. Schneider and Mr. Spiegel had previously attended the Basel conference in November 2015 where they appeared together on a panel discussion regarding naming.
|
|
ASBM Conducts 5-Hour CE Course for 100 New York Pharmacists
On November 13th, ASBM conducted a 5-hour Continuing Education (CE) course for 100 New York pharmacists in Queens, NY.
The course, entitled “Biosimilars and Biologics- Regulatory and Practice Issues for Pharmacists” was presented in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy). The course was a follow-up to the 5-hour course ASBM and LIU-Pharmacy presented in March 2015. Participating pharmacists earned 5 hours of CE credit from the New York State Board of Pharmacy.
Biosimilar policy is a rapidly-changing area of healthcare, said ASBM Advisory Board Chair Philip Schneider:
When we presented this course last year, the FDA had approved its first biosimilar just one week prior. Since then, three more have been approved, the FDA has issued Draft Guidance on both Naming and Labeling, and the number of states permitting biosimilar substitution has more than doubled. It’s important for pharmacists to stay informed.
Topics covered included the basics of biologic medicines and biosimilars, how differences between biosimilars and chemical generics affect pharmacy practice, and a discussion of laws and regulations relevant to pharmacists regarding biosimilar approval, naming, substitution, and labeling.
Read more about the CE Course, and view the presentations here.
Read Dr. Schneider’s blog about the CE course here.
|
|
Biosimilar Forum Study Confirms ASBM Survey Results
On November 1st, the Biosimilars Forum, a group of biosimilar manufacturers, released a survey which confirms several of the findings of ASBM’s survey work– including the need for greater education about biosimilars. For example:
- 60% of physicians understood that interchangeability meant that the biosimilar was considered safe and effective to be switched without resulting in negative outcomes.
- Nearly 80% of physicians also did not believe that interchangeability allows pharmacists to switch between the biosimilar and the reference product.
The study also reinforces the concern among providers regarding indication extrapolation during the approval of biosimilars. Only 12% of respondents said they trusted the extrapolation of the biosimilar indications as the basis to receive approval of other licensed indications of the reference product, the researchers reported.
Responses were obtained from a total of 1,201 U.S. physicians across specialties that are high prescribers of biologics, including dermatologists, gastroenterologists, hematologist-oncologists, medical oncologists, nephrologists and rheumatologists.
The results are to be published in the January 2017 issue of the journal Advancing Therapy and may be read here.
|
|
UPCOMING BIOSIMILAR EVENTS
World Affordable Medicines Congress
Barcelona, Spain – February 7-8, 2017
Biosimilars LATAM
Sao Paulo, Brazil – February 16-17, 2017
29th Annual DIA EuroMeeting
Glasgow, Scotland – March 29-31, 2017
|
|
|
