December 8, 2015
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 […]
December 8, 2015
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 […]
December 8, 2015
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 […]
November 20, 2015
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 […]
November 20, 2015
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 […]
November 14, 2015
Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 […]
November 14, 2015
Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 […]
November 10, 2015
On November 10th, 2015 in Basel, Switzerland, ASBM’s Advisory Board Chair, University of Arizona pharmacy professor Philip J Schneider and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, participated in a debate on the subject of distinguishable naming for biosimilars. The debate session, entitled “Naming conventions for biosimilar and […]
October 29, 2015
On October 27th, 2015, ASBM submitted comments on the FDA’s “Guidance for Industry Nonproprietary Naming of Biological Products”, released August 28th. The Draft Guidance called for distinguishable names for all biologic medicines, including biosimilars. This would be accomplished by use of a four-letter differentiating suffix composed of random letters. In the comments, ASBM commended the FDA for […]
October 16, 2015
Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was […]
