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 Releases EU Physicians’ Survey in Brussels
On March 18th in Brussels, the Alliance for Safe Biologic Medicines (ASBM) released the results of a survey of 470 European physicians from five countries regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, endocrinology and oncology. The results were released at a stakeholder roundtable hosted by EuropaBIO, with representatives from physician and patient groups, as well as industry and regulatory bodies.
Key findings showed:
- Only 22% consider themselves as “very familiar” with this new category of medicines…24% “cannot define” or “have not heard about” biosimilars before;
- 53% of those surveyed incorrectly believed that the same International Nonproprietary Name (INN) meant the products were structurally identical;
- 72% of prescribers consider it “critical” or “very important” to decide whether a patient should receive an innovator biologic medicine or a biosimilar; as a consequence…
- 74% consider it “critical” or “very important” that the mention of “dispense as written” on a prescription should be respected; and
- 62% think that it is “not acceptable” for a pharmacist to determine which biologic medicine to dispense at initiation of a treatment.
The findings stressed that using the same INN for two medicines (both the innovator biologic and biosimilar) can be misleading. In addition to implying identical structure (53% of respondents incorrectly thought this to be the case) using the same INN for both medicines may result in false attribution of adverse events if only the INN is reported (as was the case with 17% of physicians surveyed).
The survey was released in advance of the upcoming WHO INN Consultation in Geneva where ASBM will present its findings.
Michael Reilly, executive director, of the ASBM commented: “The ASBM survey is the first large-scale survey on biosimilars in Europe. It reflects the daily clinical practice with regards to biological medicines including biosimilars, and provides facts and figures that put current international, EU as well as national policy developments in the field of naming and substitution into perspective.” – Biosimilar News, March 19th
Nathalie Moll, secretary general of EuropaBIO added, “The results of the survey indicate that the understanding of biosimilars is not yet wide-spread among physicians. At the same time, doctors need to be fully aware of the characteristics of biologics and biosimilars to be in a position to prescribe the medicine that will maximize patient outcomes.” – ThePharmaLetter, March 19th
To view the ASBM survey and presentations, click here.
58th WHO INN Stakeholder Session Includes ASBM on Agenda
ASBM chairman Richard Dolinar, MD will appear before the World Health Organization (WHO) at its 58th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances meeting to be held April 8th.
The WHO has been considering creating a system of unique names and since the meeting in October has made progress toward compromise amongst the different positions on the naming of biosimilars. Currently, the WHO is contemplating assigning ‘biologic qualifiers’ — a short string of random letters added to the name of a biosimilar — which would allow physicians and pharmacists to distinguish biosimilars from the reference biologic.
Multi-stakeholder Perspectives Video on Biosimilar Naming
ASBM member Global Healthy Living Foundation (GHLF), recently produced an educational video highlighting the need and importance of unique names for biosimilars. The video includes perspectives from Steve Marmaras of GHLF, Donna Cryer a prominent patient advocate who uses biologics, former FDA official Peter Pitts, as well as ASBM executive director Michael Reilly and RetireSafe president Thair Phillips.
The two-minute video will be hosted on GHLF’s website, healthybiologics.org, and will be circulated through social media.
To view video, click here.
Indiana Governor Signs Biosimilar Legislation
On March 25th, Governor Mike Pence signed legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the U.S. Food and Drug Administration (FDA).
Senate Bill 262 amends Indiana pharmacy regulations for the treatment of biosimilars by ensuring the proper communication between the pharmacist and the prescribing physician takes place. Specifically the new law provides that the physician must indicate if a substitution is allowable and the pharmacist must notify the treating physician within 10 days of the exact biologic product dispensed by name and manufacturer. The pharmacist is required to retain a written record of the biosimilar substitution for a period of no less than two years. In addition, the pharmacist must also make sure the patient is aware of substitutions that occur.
“This law ensures there are procedures in place to facilitate the exchange of information when biologic medicines are dispensed, while also expanding patient access to biologic medicines,” stated Dr. Dolinar.
ASBM will continue to work with state legislatures in advocating for the necessary substitution guidelines needed to ensure patient safety.
To view ASBM press release, click here.
Dolinar to Speak at Discovering Cures Illinois Event
Chairman Dr. Richard Dolinar will be part of the Discovering Cures Illinois panel on April 2nd in Springfield. The event will serve as a briefing for state legislators to educate them on biosimilars and will include representatives from Biotechnology Industry Organization (BIO) and Arthritis Foundation – Heartland Region.
Discovering Cures Illinois believes that sound policy in Illinois outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe and effective biologic medicines. Discovering Cures core concerns are to ensure transparency and the primacy of the physician-patient relationship, recognizing that treating physicians and their patients are in the best position to determine appropriate therapies.
FDLI Annual Conference in April
The Food and Drug Law Institute (FDLI) will host their 57th Annual Conference on April 23rd and 24th in Washington, DC.
Breakout session “Interchangeability & Pharmacy Substitution Laws and Regulations in the United States and European Union” will cover compliance and liability issues related to biosimilars. The panel, moderated by John Manthei of Latham & Watkins LLP, will include Michael Reilly of ASBM, Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day.
For more information on the FDLI conference, click here.