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.
Lawmaker Presses FDA for Guidance on Naming, Interchangeability Policies
In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability.
“I believe clear and timely guidance on naming and interchangeability will allow both innovators and manufacturers of biosimilars a predictable, science-based pathway to what will be a robust and competitive market for biologics”, Eshoo said.
Since the 2010 passage of the Biologics and Price Competition and Innovation Act (BPCIA) authorized it to create a biosimilar approval pathway, FDA has released draft guidance on demonstrating biosimilarity and other topics. Rep. Eshoo also requested an estimate from FDA on when this guidance, issued in 2012, would ultimately be finalized.
While regulatory authorities around the world have developed differing policies on biosimilar naming, and the World Health Organization (WHO) has proposed developing an international standard to harmonize these, the FDA has yet to take a position. On the issue of interchangeability, state legislatures find themselves crafting laws allowing pharmacists to substitute interchangeable biosimilars in place of the biologics being prescribed without the benefit of the FDA guidance outlining how interchangeability will be determined.
ASBM remains engaged on these issues with policymakers at both the international and state level. (see WHO and State Update sections below)
View Eshoo letter to FDA here.
ASBM Presents at WHO 58th Consultation on International Nonproprietary Names (INN)
On April 8, ASBM Chairman Richard Dolinar, MD and Executive Director Michael S. Reilly, attended the World Health Organization’s 58th Consultation on International Nonproprietary Names (INN). ASBM spoke in support of a WHO proposal to assign a unique Biological Qualifier (BQ) to biosimilars, which would allow them to be distinguishable from their reference biologic.
“The goal of the INN is to ensure that the medicine which is prescribed is the medicine the patient receives. With biologics, we have a patchwork of regulatory attempts from many countries to deal with this problem, rather than one global solution. The proposed system would create an international standard allowing physicians, patients, pharmacists and regulators anywhere in the world to clearly identify which biologic medicine they are prescribing, dispensing, receiving or monitoring”, Dolinar said.
ASBM had previously commended the WHO for its leadership on the issue of distinguishable naming for biosimilars in a letter from Dr. Dolinar to the editors of The Generics and Biosimilars Initiative Journal (GaBI) in September of 2013. Additionally, ASBM presented its case for distinguishable nonproprietary names at the 57th INN, held in October of 2013.
Following that meeting, ASBM conducted a survey of 470 physicians in five European countries. ASBM’s European Prescriber Survey, the first of its kind in Europe, underscored the importance of distinguishable nonproprietary names:
24% of physicians surveyed ONLY report a medicine’s INN in the patient record, which could result in the patient receiving the wrong medicine.
17% of physicians surveyed report only the INN when reporting adverse events, which could lead to pooling of adverse events, false attribution, and other difficulties.
The value of distinguishable names, Dolinar emphasized, would not be limited to Europe: “For countries with a strong pharmacovigilance system, the BQ system may serve as a redundant safeguard that helps avoid a single point of information failure. For countries without such a system, it creates a consistent global standard for clarity and safety.”
ASBM Presents EU Survey Findings and Policy Updates at FDLI Annual Conference
ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA’s progress implementing the BPCIA (Biosimilars Price Competition and Innovation Act).
The panel discussed the differences between chemically-based drugs and biologics, and how these differences impact interchangeability and pharmacy substitution laws in the U.S. and E.U.
To view Mr. Reilly’s presentation for the FDLI conference, click here.
Implementation of French Biosimilar Substitution Law Emphasizes Differences from Chemical Drugs
A French law passed in January allowing biosimilar substitution in certain cases, is being mischaracterized as employing a “generics approach” to substitution. The law contains several patient protections which highlight that biologics, unlike generics, are not exact copies of their reference product.
First, the law states a biosimilar (approved by French health authority ANSM) may be dispensed only as an initial treatment to a new, or “naive” patient, and only if the physician has not stated that the prescribed biologic is “non-substitutable”. Patients currently receiving biologic treatments will remain unaffected by the law. When a substitution occurs, the pharmacist must inform the physician, and maintain records of the substitution.
In the U.S., where no biosimilars have yet been approved, legislation permitting a pharmacist to substitute a biosimilar in place of the physician-prescribed biologic has been widely debated at the state level.
European countries, however, have typically left treatment decisions to physicians and patients, avoiding “automatic substitution”. The European Medicines Agency (EMA) stated in 2012 “the physician should be in charge of the decision to switch between the reference and biosimilar, or vice versa.”
In an April interview with BioTechWatch, ASBM Executive Director Michael S. Reilly said he was encouraged by the French law’s recognition of the scientific reality that biosimilars are not identical to their reference biologic, and that physicians remain able to prevent a substitution, saying “physician-pharmacist communication and good record-keeping are absolutely vital for good pharmacovigilance”. Reilly expressed concern, however, with the law’s apparent creation of a two-tier system: “Each and every patient should be able to receive the medicine that works best for them, regardless of whether it is a biologic or a biosimilar.”
Details of the substitution policy must still be formalized by the ANSM and enacted by the Administrative Supreme Court, and substitution of biosimilars for affected patients will only begin after these decisions have been made.
State Policy Update: Biosimilars Substitution Legislation in the U.S.
On April 2nd, ASBM met with Illinois legislators in Springfield to urge them to support a biosimilar substitution bill for Illinois.
ASBM Chairman Richard Dolinar, MD gave an educational presentation to legislators entitled “Biologics and Biosimilars: Building Informed Policy at State Level” as part of the Discovering Cures Forum. The presentation emphasized the unique nature of biologics including their differences from chemical drugs, and offered physician perspectives on biosimilar substitution.
Citing ASBM’s 2012 survey of 376 physicians who prescribe biologics, Dolinar noted that 88% of physicians felt it “very important or critical” to be notified of any biologic substitution.
On April 9th, the Senate in Delaware unanimously passed Senate Substitute 1 to Senate Bill 118 which authorizes pharmacists to dispense FDA approved interchangeable biosimilars for their prescribed biological reference product.
The original bill has been amended in accordance with similar language seen recently in other states, such as Indiana, and includes the physician’s signature for “substitution permitted” as well as facilitates the communication between the pharmacy and the physician within 10 days. The language also requires the pharmacist indicate both on the prescription and on the label the name of the manufacturer of the interchangeable biologic and maintain records for at least three years.
This legislation has passed the House Health and Human Development Committee 8-3, and is now moving to the House floor for a final vote. ASBM and other stakeholders continue to urge passage of this legislation.
To view ASBM letters to the DE House of Representatives, click here.
To view legislation, click here.
On April 14th, the House Committee on Public Health also heard testimony on the issue of biosimilars. The hearing was a result of a charge by Texas House of Representatives Speaker Joe Straus to the House Committee on Public Health. The committee was asked to study the issue of biologic substitution and interchangeability in order to make recommendations on what biosimilars legislation should address for next year’s session. Texas biosimilars legislation, SB 190, died on a point of order in the current session.
ASBM will continue to monitor these developments.
BIOTECanada Joins ASBM
ASBM is pleased to announce BIOTECanada has officially joined the Alliance for Safe Biologic Medicines. BIOTECanada is an industry association with nearly 250 members located nation-wide reflecting the diverse nature of Canada’s health, industry, and agricultural biotechnology sectors.
“With the partnership of BIOTECanada, the Alliance for Safe Biologic Medicines continues to expand its global reach on the issues of patient safety and public policy surrounding biologic medications,” stated ASBM Executive Director, Michael Reilly. “BIOTECanada is a well-respected stakeholder in Canada and we are pleased to add such an influential international partner who will lend their voice to important conversations around the world surrounding biologic use and safety for patients.”
BIOTECanada and ASBM have enjoyed a strong relationship working closely on biosimilar issues in Canada. ASBM has been a participant in activities through BIOTECanada, most notably the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada held in Ottawa last June.
To learn more about BIOTECanada, click here.