On April 12th, in Geneva, Switzerland, ASBM President Doug Badger and Advisory Board Chair Philip Schneider, MS, FASHP presented to the World Health Organization as part of its 62nd International Nonproprietary Name (INN) Consultation.
On March 31st, the Alliance for Safe Biologic Medicines (ASBM) gave an educational presentation on biologics and biosimilars for 150 pharmacists attending the 31st annual Seminar by the Sea conference, held by the University of Rhode Island College of Pharmacy.
On March 23, ASBM conducted an hour-long presentations entitled “Biosimilars: New Choices, New Challenges” for a group of patients and healthcare providers in St. Louis, MO.
On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.
On February 9th, the FDA’s Arthritis Advisory Committee held a hearing on CT-P13, a biosimilar to infliximab marketed internationally as Remsima or Inflectra.
On February 2nd, ASBM’s Chairman Harry Gewanter and its Executive Director Michael Reilly participated in a panel discussion in Brussels, Belgium. The panel was held as part of a Labelling Workshop hosted by the European Biopharmaceutical Enterprises (EBE) and EuropaBio. Dr. Gewanter and Mr. Reilly discussed the findings of ASBM’s surveys of U.S. physicians and […]
This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.
On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian […]
On December 8th, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for the second biosimilar to the EU-licensed Enbrel (etanercept), a tumor necrosis factor alpha (TNFα) inhibitor. The biosimilar is seeking approvals for all indications of its reference product, which is used to treat autoimmune conditions such as rheumatoid arthritis and psoriasis. More […]
On November 19th, ASBM participated in the Expert Patient Advocates and 21st Century Therapies Forum held in Toronto, Ontario. The forum was sponsored by the Canadian Organization for Rare Disorders (CORD), which works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada. ASBM Executive Director Michael Reilly joined a patient […]