January 13, 2017
FOR IMMEDIATE RELEASE ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products (Issued January 12, 2017) ARLINGTON, Va. – The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming: We commend the FDA for its continued leadership in emphasizing the importance […]
November 18, 2016
Philip J. Schneider, MS FASHP Associate Dean, University of Arizona College of Pharmacy ASBM Advisory Board Chair This past weekend it was my honor to participate in a continuing education course for 100 New York pharmacists on the topic of biologic medicines and biosimilars, including safety and regulatory considerations which affect pharmacy practice. The 5-hour […]
November 14, 2016
On November 13th, ASBM conducted a 5-hour Continuing Education (CE) course for 100 New York pharmacists in Queens, NY. The course, entitled “Biosimilars and Biologics- Regulatory and Practice Issues for Pharmacists” was presented in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy). The course was a follow-up to the 5-hour course ASBM and LIU-Pharmacy presented in March […]
November 7, 2016
newsletter | November 2016 issue 53 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 […]
October 26, 2016
During the last week of October, ASBM participated in the AusBiotech 2016 conference, which ran from the 24th-26th in Melbourne, Australia. The event attracted more than 2000 attendees, including Australian regulators, physicians, patients, researchers and biologic manufacturers. Andrew Spiegel, executive director of the Global Colon Cancer Association, an ASBM Steering Committee member, represented ASBM at the […]
October 6, 2016
On October 5th, ASBM Executive Director Michael Reilly and Steering Committee member Andrew Spiegel of the Global Colon Cancer Association, met with Health Alberta regulators to offer ASBM’s perspectives on Canadian biosimilar policy. Reilly and Spiegel shared data from ASBM’s survey of Canadian prescribers. ASBM counts 12 Canadian patient groups among its membership, and ASBM member IAPO […]
October 6, 2016
On September 30th, An op-ed appeared in the Detroit News, authored by Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN), an ASBM Steering Committee member. Ms. Horn discusses how legislation permitting biosimilar substitution could help Michigan patients. Similar legislation has been passed in 25 states and Puerto Rico. A key provision […]
September 29, 2016
On Friday, September 23rd the FDA approved its fourth biosimilar, Amjevita (adalimumab-atto). Amjevita (adalimumab-atto) was approved for seven adult indications of its reference product, Humira (adalibumab): moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and […]
September 28, 2016
SÁO PAULO, BRAZIL- The Latin American Chapter of the Alliance for Safe Biologic Medicines (ASBM) and the Global Colon Cancer Association (GCCA) today participated in a biologics and biosimilars forum in Sáo Paulo, Brazil. The chapter is comprised of eight patient organizations representing a variety of disease groups including multiple forms of cancer, hepatitis, and […]
September 21, 2016
By Michael Reilly, Executive Director, ASBM To date, the FDA has approved three biosimilars. The first, Zarxio (filgrastim-sndz), used a meaningful, memorable suffix based on the manufacturers name (Sandoz). The second two use the random suffixes “-dyyb” and “-szzs” which mean, well, nothing. ASBM’s surveys have shown that physicians (78%) and pharmacists (85%) support memorable […]
