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.
Dolinar Letter to the Editor Published by GaBI in Advance of WHO Naming Meeting
On September 27th, a Letter to the Editor by ASBM Chairman Richard Dolinar, M.D. was featured in the Generics and Biosimilars Initiative Journal (GaBI). The piece commends the World Health Organization (WHO) for its attention to an upcoming action on the issue of non-proprietary names for biologic medicines.
In the article, Dolinar writes, “WHO has shown thoughtful leadership in facilitating the further development of effective biological identification via a unique and universally available designated name for each pharmaceutical substance. This action is very timely in light of the growing number of biosimilars and non-biocomparables arriving on the market.”
The letter also points to recent action by Australia’s Therapeutic Goods Administration (TGA) which has already moved forward on WHO’s version for biologicals and biosimilars naming conventions.
GaBI aims to raise the scientific status of generic and biosimilar medicines, and to provide comprehensive, high quality, scientifically sound, reliable, well-documented and up-to-date information about generic and biosimilar medicines both in print and electronically in an open access format.
To read Dolinar’s full Letter to the Editor, click here.
ASBM Set to Attend 57th WHO INN Consultation
Dr. Dolinar and ASBM Executive Director, Michael Reilly, are set to attend the World Health Organization’s 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances held October 22nd in Geneva.
There has been considerable interest recently on the importance of this meeting worldwide as the biologics debate moves forward and other countries seek to develop appropriate pathways. ASBM plans to further advocate at the WHO stakeholders meeting on the importance of using distinct non-proprietary names to ensure patient safety.
ASBM has issued two letters this year directly to the WHO in advance of the meeting. Furthermore, both Dr. Dolinar and Mr. Reilly have met with Dr. Balocco, INN Program Director, at the HeathCanada/BiotechCanada Naming forum hosted this summer.
To read ASBM letters to the WHO, click here.
IAPO Mexico City Meeting Includes Discussion on Biosimilars
On September 23rd, in Mexico City, the International Alliance of Patients’ Organizations (IAPO) hosted a discussion on biosimilars at their Latin American Multi-Stakeholder Seminar. The meeting was attended by patient and interest groups from the region as well as ASBM Executive Director, Michael Reilly, and Global Colon Cancer Association (GCCA) Co-Executive Director, Andy Spiegel.
The discussion focused on how patient groups can influence biosimilar health policy in Latin American countries, especially Mexico and Columbia, and the need for stringent global regulatory standards that ensure patient safety when it comes to these complex medicines.
ASBM Steering Committee member, GCCA, has officially joined the International Alliance of Patients’ Organizations (IAPO) this year. The Mexico City event served as an opportunity to build on IAPO’s interest in the biosimilars issue following the successful Workshop on Biosimilars Medicines held in Geneva earlier in the year. IAPO is a global alliance of over 200 patients’ organizations representing 50 disease areas and over 60 countries worldwide.
Stateside: Biosimilars Legislative Updates
California
Senate Bill 598, legislation updating California’s pharmacy law, was sent to Governor Jerry Brown after passage of both chambers in the State Legislature by favorable margins. The legislation creates a safe process for the substitution of FDA approved interchangeable biologic medicines by ensuring the proper communication between pharmacist and physicians is taking place. It requires physician notification of switches and gives doctors the ability to indicate ‘do not substitute’ on medications for their patients. Appropriate record keeping is also required by the pharmacist for the ability to track and trace any potential adverse reactions in patients.
Patient groups are advocating for Governor Brown to sign SB 598 before the October 13th deadline. Without such legislation, patients in California would not have access to biosimilars or any potential benefits they may bring.
Pennsylvania
On September 11th, the Pennsylvania House of Representatives Health Committee hosted a hearing on HB 746, biosimilars legislation.
At the hearing, Chairman Matthew Baker and other committee members heard from a number of stakeholders who support HB 746.
Andrew Spiegel gave testimony in support of the bill and discussed why its passage will benefit patients with colon cancer. Other ASBM members, including the Global Healthy Living Foundation, were in attendance.
Read Andrew Spiegel’s testimony here.
Indiana
The Indiana Senate Health Finance Committee will hold a hearing on Tuesday, October 22nd in Indianapolis to discuss biosimilars substitution practices in their state.
On October 14th, in advance of the Senate hearing, Discovering Cures Indiana and the Indiana Health Industry Forum are hosting an educational event on biosimilars at the Indiana University Innovation Center.
Discovering Cures Indiana and the Indiana Health Industry Forum want to ensure leaders in their state are properly educated on the complexities of biologics and biosimilars and the need for changes to current practices to make sure patient safety is preserved. Their core concerns are to ensure transparency and maintain the primacy of the physician-patient relationship when developing public policy.
Forum panelist will include Dr. Richard Dolinar of ASBM, as well as the Biotechnology Industry Organization (BIO), policy makers and other patient advocates.
See the IN invite here.
NALEO to Welcome Dr. Dolinar as Key Speaker on Biosimilars
On October 26th in Las Vegas, Dr. Richard Dolinar will be the luncheon speaker at the National Association of Latino Elected and Appointed Officials (NALEO) Legislative Summit on Health. Over forty state legislators from across the United States are planning on being in attendance. While the NALEO summit will focus on the sum of the Patient Protection and Affordable Care Act, Dr. Dolinar will speak on the science and policy issues surrounding the FDA’s approval of biosimilars for patient use.
NALEO is the nation’s leading non-profit organization that facilitates the full participation of Latinos in the American political process. Currently, NALEO represents more than 6,000 Latino elected and appointed officials and conducts advocacy on issues important to their community.
