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.

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation  On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences for patient access that may result from the implementation of IRA provisions. The webinar, entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines will be held on July 26th. REGISTER HERE.   View the agenda Speakers will include:Thomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC), USACharles Clapton,Vice President, Federal Government Affairs, Gilead Sciences, USAMatias Olsen; Public Affairs & Policy Manager, EUCOPE, Belgium Steven Potts, PhD, MBA; CEO, Anticipate BioscienceMichael S Reilly, Esq; Executive Director, Alliance for Safe Biologic Medicines, USAPhilip Schneider, FASHP, FFIP Past Vice President, International Pharmaceutical Federation (FIP) Andrew Spiegel, Esq;  Executive Director, Global Colon Cancer Association, USAThe webinar will focus on the IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid to negotiate prices of certain costly drugs, including many biologic medicines. Webinar presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and on the practice of healthcare professionals including physicians and pharmacists. REGISTER for the webinar here. View the agenda.

ASBM Chair Presents Poster Abstract at DIA Global Annual Meeting 2023 On June 26th, ASBM Chairman Ralph McKibbin presented a poster at the DIA Global Annual Meeting in Boston, MA. The poster was based on the findings from ASBM’s Canadian ophthalmologist survey and compared the findings with those of other physicians surveyed in recent years. The surveys examined physician attitudes toward biosimilar substitution practices, pharmacovigilance and nomenclature standards, and different biosimilar access scenarios.  View the poster For example, 81% of ophthalmologists were uncomfortable with a third-party payer (such as a government or private insurer) switching their patient’s biologic medicine for non-medical reasons (e.g. cost or coverage), as occurs under the government health plans of several provinces. 90% believe treatment decisions should rest with the physician and patient, and 91% believe they should be able to prevent a forced switch. Ophthalmologists are the latest group of physicians to raise concerns with the practice of forced switching- which has become increasingly common among Canadian provinces.  View Dr. McKibbin’s video walkthrough of the poster Prior ASBM surveys across many specialties revealed that 83% of Canadian, 82% of European, and 69% of U.S. physicians consider it very important or critical that the physician and patient control treatment decisions, including the decision to switch to a biosimilar. 79% of Canadian, 84% of European, and 67% of U.S. physicians considered the ability to prevent a substitution similarly important. View the poster here.  View Dr. McKibbin’s video walkthrough of the poster here.

OSU College of Pharmacy Promotes ASBM CE Course on Biosimilars  The Ohio State University College of Pharmacy is promoting a 7-part, 7 hour Continuing Education course for pharmacists about biosimilars.  From the College’s email: Pharmacy is a rapidly changing profession where new breakthrough medications offer relief to patients in novel ways. Biosimilars are a relatively new class of drugs for which the old rules of pharmacy don’t necessarily apply.  The Biosimilars Continuing Education Series is a self-paced, seven-course sequence that offers new insights into biosimilars. These courses are individually accredited and count as continuing education credits. The series was developed by ASBM in conjunction with the College of Pharmacy’s Office for Continuing Professional Development and features several ASBM speakers including:Immediate Past Chair Madelaine Feldman, MD FACRChairman Ralph McKibbin MD FACP FACG AGAFAdvisory Board Chair Philip Schneider MS FASHP FFIPSteering Committee Member Andrew Spiegel, Esq.The course is available to pharmacists nationwide for 7 hours of CE credit.  ASBM members who are interested in learning more about how biosimilars affect healthcare practice may view the course for free.  ASBM Members may request a free access code here.  Read more about or register for the course here.   Watch a video overview of the course here.

Eli Lilly Cancels Three Drugs Due to IRA Price “Negotiation” Provisions Drug manufacturer Eli Lilly and Company has reportedly stopped development of three new drugs due to last year’s Inflation Reduction Act, which for the first time permits Medicare to “negotiate,” or set prices, for certain drugs. Lilly CEO David Ricks discussed the law’s chilling effect on innovation at a June 14th event hosted by J.P. Morgan to discuss the IRA’s impact on drug development. As reported in the Pink Sheet“: “Already investors are making those decisions. We are making those decisions, which is deemphasizing programs that would have been pursued as productive that are no longer productive,” Ricks said. A forecast from the Congressional Budget Office (CBO) that predicted the IRA would result in around 15 fewer drugs after 10 years under-appreciated the impact, he said. “I can tell you, after nine months, there are three fewer Lilly drugs,” he said. “We are 5% of the US market, so their estimate is off by orders of magnitude in terms of how much effort will gointo small molecules.” The IRA has been widely criticized for imposing a “small molecule penalty”- offering small-molecule drugs only 9 years’ time to recoup development costs, while large-molecule biologic drugs have a 13-year period to do so. This shorter window makes development of small-molecule drugs- including many cancer treatments- less profitable for manufacturers to develop.  Read the full article here (subscription required).  Read ASBM Steering Committee Member Andrew Spiegel’s article about the small-molecule penalty here.

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS ASBM/ GaBI Webinar: Medicare Drug Price NegotiationVirtual- Register Here – July 26, 2023 WHO 77th INN Consultation Geneva, Switzerland – October 17, 2023  World Drug Safety Congress AmericasBoston, MA – October 18-19, 2023ACR Convergence 2023 San Diego, CA – November 10-14