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 Authors Second Letter to WHO on Naming
ASBM Chairman Richard Dolinar, M.D., submitted a letter on July 31, 2013, to Dr. Margaret Chan, World Health Organization Director-General to reiterate ASBM’s position on the importance of using distinct non-proprietary names to ensure patient safety. The letter was sent to Dr. Chan and to the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation Division at the WHO in advance of their upcoming 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances to be held in Geneva on October 22, 2013.
Read letter here.
In addition to the letter to Dr. Chan, ASBM also formally requested to participate in the October 22nd meeting in Geneva.
Biosimilars Legislative Update – California
While most U.S. state legislative sessions have died down for the summer, California is nearing the finish line to pass vital patient safety legislation concerning biosimilars.
Senate Bill 598 has received a favorable position in the California Assembly, passing the Health Committee; the Business, Professions and Consumer Protection Committee; and the Appropriations Committee by favorable margins. The bill was considered by the full Assembly Monday, August 26th and passed with an overwhelming vote of 58-4. It now returns to the Senate for hopeful completion before the CA session ends on September 13th.
Global Colon Cancer Alliance Joins IAPO
ASBM Steering Committee member, Global Colon Cancer Alliance (GCCA) has officially joined the International Alliance of Patients’ Organizations (IAPO). IAPO is a global alliance of over 200 patients’ organizations representing 50 disease areas and over 60 countries worldwide. IAPO works in a creative and innovative way towards its vision of patient-centered healthcare and has a network that connects over 4,000 organizations and an estimated 365 million patients worldwide. GCCA will now officially be part of a larger, international network providing new opportunities to speak on colon cancer issues and well as share their thoughts on biosimilars.
IAPO to Discuss Biosimilars at Mexico City Regional Meeting
IAPO’s Governing Board Member, Eva Maria Ruiz de Castilla, will feature a discussion on biosimilars during IAPO’s upcoming Latin American Multi-Stakeholder Seminar, September 23rd in Mexico City. The seminar will continue to advance IAPO’s primary mission which is to inform and engage patient groups so that they can better advocate for patient-centered policies worldwide. The Mexico City event serves 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. The Geneva workshop brought together 19 patients’ organizations and other healthcare stakeholders from around the world to discuss what biosimilars are and what they mean to patients. ASBM Executive Director Michael Reilly and GCCA Co-Executive Director Andy Spiegel presented at the Geneva Workshop and are planning to attend the Mexico City seminar as well.
NALEO to Focus on Biosimilars at Legislative Summit
The National Association of Latino Elected and Appointed Officials (NALEO) is hosting their Legislative Summit on Health, October 25-27 in Las Vegas, NV. The October summit will focus on The Patient Protection and Affordable Care Act and will include a session focused on biosimilars.
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.
Australia Releases Guidance on Biosimilars
Building on similar European documents, Australia’s Therapeutic Goods Administration (TGA) recently released guidance to help drugmakers identify the data necessary to support the registration of biosimilars, in-Pharma Technologist reports. The TGA clarifies the scientific and regulatory requirements needed to bring biosimilars to the Australian market, which includes that manufacturers have to provide evidence that they have established in-house reference standards comparable to the reference biologic.
Read full article here.
AADA’s Board of Directors Updates Position on Biosimilars
ASBM Steering Committee member, American Academy of Dermatology, has formally updated their position statement on biosimilars. The Board of Directors approved changes on August 3rd. Those changes are based on a better understanding of legislation under consideration in many of the U.S. states, as well as the FDA’s possible approach in approving and regulating biosimilars. Specifically, the Board has included that “the pharmacist notifies the prescriber in writing or electronic communication by the time of dispensing.”
To view full statement click here.
IFPMA Launches New Publication on the Scientific & Regulatory Considerations of Biosimilars
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published, “Similar Biotherapeutic Products – Scientific & Regulatory Considerations”. The piece includes a visual timeline of the development and manufacturing process of these products, as well as a unique illustration of how the biotech process works. Furthermore, the publication explains the science behind biotherapeutics and how they are not the same as chemically-synthesized molecules, which have a simpler chemical structure. This in-depth, yet easy to digest, publication helps to explain the concerns of the quality, safety, and efficacy issues faced in manufacturing biologics and in any biosimilar product.
Access publication here.
Upcoming DIA Conferences You Won’t Want to Miss
The Drug Information Association (DIA) will soon be hosting two forums on biologics in the Greater Washington, DC area.
The Development of Live Biotherapeutics: September 24, Hilton- Washington DC, Rockville, MD. This conference is set to provide a better understanding of the unique opportunities and challenges in the development of live biotherapeutics that will enable more translational research to move forward into therapeutics.
Click here for more information.
DIA Biosimilars 2013: November 13-14, Hyatt Regency, Bethesda, MD. This seminar is focused on supporting the growing sector of biosimilars. The meeting will focus on the challenges, innovations and technologies surrounding biosimilars.
Click here for more information.
ASBM Newsletter Now Available on the Web
ASBM newsletters are now on the web! All newsletters for the 2013 calendar year have been posted for easier reference and to share the exciting activities of ASBM. This one-stop update can be accessed on the bottom right-hand corner of the homepage or under the media toolbar. Join us in sharing this link with other allies in your community.
Click here to see the ASBM newsletter section.
