October 1, 2018
On September 30th, ASBM presented a 5-hr Continuing Education (CE) course for more than 75 New York area pharmacists. The majority of these attendees were drawn from community pharmacy practice, with a smaller number practicing in health system pharmacy. The CE course was presented in conjunction with The Arnold and Marie Schwartz College of Pharmacy […]
September 28, 2018
September 26th, ASBM held a 2-hour Continuing Education (CE) course for Rhode Island pharmacists. The course was presented in conjunction with the Rhode Island Society of Health-system Pharmacists (RISHP) and the University of Rhode Island College of Pharmacy. The course began with remarks from RISHP’s Raymond Iannuccillo, PharmD, an oncology research pharmacist with Rhode Island Hospital, who […]
September 27, 2018
On September 21st, 2018 ASBM submitted comments to FDA as a follow-up to September 4th Public Hearing “Facilitating Competition and Innovation in the Biological Products Marketplace”, at which three ASBM Chairs, and several Steering Committee members testified. The purpose of the hearing and the request for comments, is to seek input on how the FDA can achieve the following goals: […]
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 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 […]
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 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 […]
