September 14, 2018
The Biosimilar Working Group, a Canadian-based coalition of non-profit organizations, registered health charities, and health care advocacy coalitions, launched its website this month. The launch was announced in conjunction with the Group’s September meeting in Toronto, ON. The Biosimilars Working Group is dedicated to ensuring that good outcomes for patients are at the centre of health […]
September 13, 2018
On September 4th, 2018, the U.S. Food and Drug Administration (FDA) held a hearing on the Biosimilar Action Plan announced by FDA Commissioner Scott Gottlieb in July. The action plan addressed 4 key areas intended to improve biosimilar competition: Improving the efficiency of the biosimilar and interchangeable product development and approval process Maximizing scientific and regulatory clarity […]
July 24, 2018
On July 18th, ASBM Advisory Chair Philip Schneider gave a presentation to the Malta Pharmaceutical Association entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals […]
July 24, 2018
On July 20th, the FDA approved Pfizer’s Nivestym, (filgrastim-aafi,) the second biosimilar to Neupogen (filgrastim), manufactured by Amgen. The drug is approved for the same indications as the reference product, including decreasing the incidence of infection due to neutropenia. Specifically, the drug has been approved to treat side effects from cancer treatment for patients: With acute […]
July 13, 2018
On July 12, in Washington, DC the Alliance for Safe Biologic Medicines (ASBM) hosted the second in a series of meetings to discuss the global harmonization of nomenclature for biologic and biosimilar medicines. Representatives from the World Health Organization, the U.S. Food and Drug Administration (FDA), Health Canada, the United States Pharmacopeia (USP), and the American […]
June 30, 2018
From June 25-27, ASBM exhibited at the 2018 Drug Industry Association Conference (DIA 2018). ASBM was represented at DIA by Chair Madelaine Feldman MD, FACR and Advisory Board Chair Philip Schneider, MS FASHP. In addition to meeting attendees at ASBM’s booth, Drs. Feldman and Schneider attended several panels related to biosimilar policy, and engaged participants […]
June 12, 2018
On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers. ASBM Advisory Chair Philip Schneider gave a presentation […]
June 6, 2018
On June 4th, the U.S. Food and Drug Administration approved its eleventh biosimilar, Fulphila (pegfilgrastim-jmdb). This is the first biosimilar to Neulasta (pegfilgrastim) and is prescribed to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), […]
May 20, 2018
On May 19th, ASBM presented an abstract during the poster session at the World Health Professions Regulation Conference 2018 in Geneva, Switzerland. ASBM’s poster, entitled “How do policymakers realize the cost-savings from biosimilars while maintaining healthcare provider autonomy?” draws from ASBM’s surveys of 1,832 physicians in 12 countries and 401 pharmacists in the U.S. The findings […]
May 18, 2018
On May 1st, ASBM Executive Director, Michael Reilly, Esq. and Advisory Board Chair, Philip Schneider, MS, FASHP; presented before the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the tenth INN Consultation at which ASBM has presented since 2013. While the discussions in the Open Session at which ASBM presented are […]
