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newsletter | February 2020issue 85
Who We Are
The Alliance for Safe Biologic Medicines is an organization composed 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 ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.For media inquiries please contact: media@safebiologics.orgAlliance for Safe Biologic MedicinesPO Box 3691Arlington, VA 22203(703) 960-0601Follow UsTwitter: @SafeBiologics
FDA Enhances Purple Book to Support Transparency in Biosimilars
On February 24th, the FDA announced that it will be upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases. The updates will include full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products. FDA Commissioner Stephen M. Hahn, M.D. said of the update:“This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.
“We’re confident these enhancements will meet the needs of a wide range of users, from providing a simple search for patients and consumers, to a more advanced search for prescribers, researchers and industry representatives that may have a need for more technical information.
“Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”
Read more about the updates here.
ASBM Conducts 4th 5-Hour CE Course for NY Pharmacists On February 23rd, ASBM presented a Continuing Education (CE) course entitled “Biosimilars- What’s New in 2020?“ to a gathering of more than 75 New York-area pharmacists.
The event took place at the LaGuardia Marriott in East Elmhurst, NY and was hosted by ASBM and Long Island University College of Pharmacy (LIU-Pharmacy). This is the fourth time ASBM has presented a course on biosimilars with LIU-Pharmacy; read about previous courses here: March 2015, November 2016, and September 2018.
The five-hour program consisted of seven presentations, each focusing on an important aspect of biosimilars:
- ASBM Advisory Board Chair Philip Schneider gave presentations on the basics of biologic and biosimilar medicines; biologic naming and international harmonization efforts; why pharmacists should care about biosimilars; and comparing US biosimilar substitution policy among those of other advanced countries.
- ASBM Chair Madelaine Feldman, MD, FACR provided a physician perspective on these issues, and supported her comments with recent survey data from prescribers in the U.S. and Europe regarding biologic naming and substitution policies.
- ASBM Steering Committee member Andrew Spiegel, executive director of the Global Colon Cancer Association, provided a patient advocate’s perspective on biosimilars, with an emphasis on the issue of non-medical switching.
- Dan Tomaszewski, PhD, PharmD, Assistant Professor at Chapman University College of Pharmacy, examined the role of pharmacists in biosimilar use, and discussed pharmacist-specific considerations of dealing with PBMs, insurers, and patients.
Interspersed with these were five short videos featuring interviews with additional patients, physicians, and pharmacists. These included inaugural ASBM Chair Richard Dolinar, MD; Immediate Past Chair Harry Gewanter MD FACR; and ASBM Steering Committee member and patient advocate Kathleen Arntsen, CEO of the Lupus and Allied Diseases Association.
Read a detailed description of the program and view all the presentations and videos here.
ASBM, Gastrointestinal Society Submit Joint Comments on Canadian Pricing Proposal On February 14th, ASBM and the Gastrointestinal Society jointly submitted formal comments on the Canadian Patented Medicine Pricing Review Board (PMPRB) Draft Guidelines, as part of a stakeholder consultation by the PMPRB. From the comments:
As advocates representing millions of Canadian patients, the Alliance for Safe Biologic Medicines (ASBM) appreciates the opportunity to comment on the PMPRB’s new Draft Guidelines. ASBM is a global alliance of patient advocacy organizations and physician societies, working to promote patient-centered biosimilar policies worldwide.The Gastrointestinal Society is one of our leading Canadian members, and represents as many as 6 million Canadians with irritable bowel syndrome (IBS), more than 9 million with functional dyspepsia, as many as 8 million with chronic acid reflux (GERD), and an additional 233,000 suffering from chronic inflammatory bowel disease (Crohn’s and ulcerative colitis).We are keenly aware of the importance to the patients we represent of increasing access to new and innovative life-improving and life-extending therapies by ensuring affordability of these medicines.However, pricing policies alone do not guarantee access; other factors contribute as well. Ensuring that new medicines available to patients in other advanced countries are launched in Canada as well is among these key factors.It is our view that while well-intentioned, the new Draft Guidelines have a strong potential to upset this critical balance, by disincentivizing manufacturer investment in product launches and dissuading applications for subsequent indications in Canada, thereby jeopardizing, rather than promoting, patient access to such therapies.Read ASBM’s and the Gastrointestinal Society’s joint comments in their entirety here.FDA Announces Increased Collaboration with FTC to Address Anti-Competitive Practices in Biosimilar Market. On February 3rd, the U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.
“Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”“Biologics are essential to the treatment of many serious illnesses. Practices in biologics markets are delaying the availability of biosimilar products, thereby depriving patients of the benefits of competition, including lower prices and increased innovation,” said FTC Chairman Joseph Simons. “The FTC is committed to continuing to enforce the antitrust laws in healthcare markets, including those for biologics and biosimilars.”
Draft Guidance and Comment PeriodThe FDA has published draft guidance outlining its current thinking on presenting data and information in a truthful and non-misleading way about biosimilars and reference products in FDA-regulated promotional materials. It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may encounter.
These announcements are key deliverables in the FDA’s Biosimilars Action Plan (BAP) that outlines four key strategies to accelerate biosimilar competition, including supporting market competition and providing clearer direction to industry on the development of promotional materials for medical products.
The FDA is accepting comments from the public on the draft guidance from February 4 to April 6.
Comments may be submitted here.
UPCOMING EVENTS DIA European Meeting 2020
Brussels, Belgium – March 17-19, 2020
WHO 70th INN Consultation
Geneva, Switzerland – April 21, 2020
Digestive Disease WeekChicago, IL – May 2-5, 2020
