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.
GaBI Publishes ASBM Whitepaper on European Prescriber Survey
On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly.
The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western European countries: the United Kingdom, France, Germany, Italy, and Spain.
The responses demonstrated a need for further education about the nature of biosimilars, and underscored the need for biosimilars to have distinguishable nonproprietary names from their reference products.
Of the physicians surveyed, 53 percent mistakenly believed an identical nonproprietary name implies identical structure; and 61 percent said that identical nonproprietary names imply that the medicines are approved for the same indications, which may not be the case.
Additionally, 24 percent of respondents said they recorded only the nonproprietary name of the biological product in the patient record. Without unique nonproprietary names to distinguish biosimilars from their reference products, this could result in pooling of adverse events, misattribution, and other difficulties.
The survey was conducted in November of 2013, and its results were presented by ASBM to the World Health Organization as part of its 58th Consultation on International Nonproprietary Names in April.
View GaBI paper here.
Delaware Governor Signs Biosimilars Substitution Bill
On May 28, Governor Jack Markell enacted legislation updating Delaware’s pharmacy law and paving the way for the safe substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after overwhelming votes in both the State House and Senate and with much participation from ASBM members.
Senate Substitute 1 to Senate Bill 118, which authorizes pharmacists to dispense FDA approved interchangeable biosimilars for their prescribed biological reference product, contains the appropriate balance of safeguards by facilitating communication between physician and pharmacist, as well as outlines recordkeeping of transactions. Specifically, pharmacists are to communicate to the patient that a substitution has been made, and also notify the prescribing physician within a period of 10 days. The physician would maintain the right to prohibit substitutions from occurring if in the best interests of their patient. Pharmacists are also to record vital labeling and manufacturing information to ensure the proper track and trace procedures, and keep these records for a period of three years.
ASBM and its membership were extremely active in the legislative process in Delaware, by presenting compelling patient testimony, sending in statements of support and conducting one-on-one meetings with legislators. Andy Spiegel, Co-Chair of the Global Colon Cancer Association, also participated in a meeting with the Governor at which he was able to share important ASBM physician survey data.
“By ensuring communication between physicians, pharmacists and patients remains a priority, we can safely monitor these complex therapies while providing the best quality and care,” concluded Richard Dolinar, MD, Chair of the Alliance for Safe Biologic Medicines. “We commend Governor Markell and the General Assembly for taking the necessary steps to protect Delaware patients and advance more treatment options.”
New FDA Guidance Issued on Clinical Pharmacology Data
This month, the FDA released its fifth guidance document to continue to forge a pathway for biosimilars in the United States.
The guidance was published to assist companies in developing the appropriate databases, and utilization of modeling and simulations in the design of clinical trials for the approval of biosimilar medicines. While technical in nature, the document is said to be consistent with the advice FDA has been giving companies verbally on the clinical pharmacology data needed to demonstrate the biosimilarity of a biosimilar to its reference product. The guidance provides information about how to appropriately use data from products marketed outside the United States. Other countries, particularly the EU, have had biosimilars on the market for several years and may offer useful pharmacokinetic and pharmacodynamic data which could potentially be used to demonstrate biosimilarity.
The FDA continues to encourage companies looking to introduce biosimilars to engage in early conversations with the FDA in designing the appropriate studies to show that a proposed therapeutic biologic product is biosimilar to the original biologic.
View FDA Guidance Documents here.
SWHR Writes Letter to FDA on Naming, Gender Disparities
In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWHR) along with over 45 other organizations including some ASBM members, asked the FDA to consider gender disparities when it comes to biosimilars naming policies, as well as interchangeability and therapeutic substitution.
SWHR writes:
“As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the U.S. we ask that you give serious consideration to the impact of these policies on women’s health. Women are often underrepresented in clinical trials… Accordingly, the long-term effects and adverse reactions of biologics on female patients is not known. Distinguishable names will lead to better health outcomes for women by enabling the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for women.”
Read letter to the FDA here.
ASBM Invited to Share EU Survey Findings in Paris,
Webcast Around the Globe
On June 10, ASBM Executive Director Michael Reilly will be traveling to Paris to present the results of the ASBM European Prescriber Survey. The event, hosted by Abbvie, will be webcast across the world giving ASBM a chance to share its findings on the issues of naming, interchangeability and substitution of biosimilars.
ASBM’s European Prescriber Survey data remains first-of-it’s-kind results on physicians’ knowledge and experiences with biosimilar medicines. ASBM originally released the survey results in Brussels in March, but has also presented findings before the World Health Organization (WHO).
“It is important that regulatory bodies and those following this global discussion understand the careful balance that we must strike to continue to ensure the safety and efficacy of these medicines,” stated Mr. Reilly.
ASBM Set to Present at DIA Annual Conference
On June 19, ASBM Chairman Richard Dolinar, MD will present at the Drug Information Agency’s (DIA) 50th Annual Meeting that will be held in San Diego, California.
The session entitled, “Trends in Biosimilars Regulation Within Developed and Emerging Markets” will be an assessment of current debates within the regulatory landscape of biosimilars. Since Dr. Dolinar has just returned from presenting ASBM’s case for distinguishable nonproprietary names at the WHO’s 58th International Nonproprietary Naming (INN) Open Session convention held in April, he will speak first-hand on the emerging consensus around the naming of biosimilars and the potential use of biological qualifiers (BQ). In addition, Dolinar will share the results of the ASBM European Prescriber Survey which reflects the current thinking of physicians in the EU and underscored the importance of distinguishable nonproprietary names, as well as highlights areas of concern amongst substitution policies.
To learn more about the DIA Conference, click here.
Annual BIO Convention Features ASBM Members
On June 23-26, the Biotechnology Industry Organization (BIO) will host its International Convention in San Diego, CA.
This year’s convention will feature a panel of ASBM members including:
ASBM Steering Committee member Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN); ASBM International Advisory Board member and Associate Dean of the University of Arizona College of Pharmacy, Phillip Schneider; and also ASBM International Advisory Board member, Robert Yapundich, MD.
The session entitled, “Ensuring the Safety and Commercial Success of Biosimilars in the United States,” will discuss how the United States can move forward to ensure patients have access to high quality, safe and effective biosimilars. Panelist will focus on the impact of international naming conventions, state substitution policies and other such issues facing regulators. It will also examine lessons learned from the European experience with biosimilars.
The BIO International Convention regularly draws over 15,000 attendees, and offers key networking and partnering opportunities, as well as provides insights on major trends affecting the industry.
For more information or to attend the BIO convention, click here.
National Psoriasis Foundation Joins ASBM
This May, the National Psoriasis Foundation (NPF), which is the voice for the 7.5 million Americans who are affected by psoriasis and psoriatic arthritis, joined the Alliance for Safe Biologic Medicines. NPF is the second organization to be added as a new member in the last few months, contributing to the growth of ASBM and its influence.
“ASBM is pleased to welcome the National Psoriasis Foundation and their patients as we continue to pursue the best solutions on biologic policy to ensure patients safe access to life-enhancing treatments. NPF represents the increasing population of individuals who are affected by biosimilars policies and we are pleased to add such a strong advocacy group to the ASBM ranks,” stated ASBM Executive Director, Michael Reilly.
NPF’s mission is to find a cure for psoriasis and psoriatic arthritis and to eliminate their devastating effects through research, advocacy and education. Through advocacy, the Psoriasis Foundation works to increase government investments in finding a cure, influence decision-makers to strengthen their focus on psoriasis and psoriatic arthritis and improve access to care.
To learn more about the National Psoriasis Foundation, click here.
