Press Releases – Page 2 – Safe Biologics

ASBM Releases Fact Sheet on British Columbia vs EU Substitution Policies

August 5, 2019

As BC attempts to increase biosimilar use by force-switching 23,000 patients, Europe enjoys high uptake rates while preserving patient and physician choice. On August 5th, ASBM released a fact sheet contrasting the biosimilar substitution policies of European countries (which generally have robust biosimilar markets) with the newly announced British Columbia policy. First fact sheet also addresses misconceptions […]

Patients, Physicians Raise Concerns with BC Biosimilar Non-Medical Switching Policy

June 6, 2019

ARLINGTON, Va., June 6, 2019 /PRNewswire/ — On May 27th, the Government of British Columbia (B.C.) announced a policy that will forcibly switch thousands of patients with serious, chronic conditions from their current biologic medicines to lower-cost “biosimilar” treatments, effective November 25th, 2019. The roughly 23,000 patients who will be affected include those with rheumatoid arthritis, plaque psoriasis, […]

Patients, Physicians Raise Concerns with BC Biosimilar Non-Medical Switching Policy

June 6, 2019

ARLINGTON, Va., June 6, 2019 /PRNewswire/ — On May 27th, the Government of British Columbia (B.C.) announced a policy that will forcibly switch thousands of patients with serious, chronic conditions from their current biologic medicines to lower-cost “biosimilar” treatments, effective November 25th, 2019. The roughly 23,000 patients who will be affected include those with rheumatoid arthritis, plaque psoriasis, […]

Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products

May 14, 2019

Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products May 13, 2019 Arlington, VA – US physicians and patient advocacy organizations expressed their overwhelming support for the FDA’s suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency. Biologic medicines treat […]

ASBM Statement Supporting Updated FDA Naming Guidance

March 12, 2019

ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars, going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars. This policy ensures that patients and health care providers can distinguish between products when that is […]

Statement from ASBM Executive Director Michael Reilly in Response to a Mischaracterization of ASBM’s Work in January 10 Washington Post Article

January 16, 2019

On January 10, 2019, the Washington Post published an article “Patients stuck in corporate fight against generic drugs.” I spoke extensively with the author of the article and also suggested that he speak with the Chair of the Alliance for Safe Biologic Medicines (ASBM) international advisory board Dr. Philip Schneider. Unfortunately, the article did not represent […]

ASBM Presents at 67th WHO INN Consultation

November 6, 2018

On October 23rd, ASBM Advisory Board Chair, Philip Schneider, MS, FASHP and Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, presented before the 67th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the eleventh INN Consultation at which ASBM has presented since 2013. While the discussions […]

Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now

October 22, 2018

Regulators, Physicians, Patients to WHO: A Harmonized Biologic Naming Protocol is Important to Patient Safety; Please Act Now A whitepaper released today by the Alliance for Safe Biologic Medicines calls on the World Health Organization (WHO) to implement a harmonized naming protocol for biologic medicines to help keep patients safe. Names – of products, people, […]

ASBM Submits Comments to FDA on Biosimilars

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: […]

Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards

February 8, 2018

For Immediate Release Naming Tool for Biologic Medicines Released; Ensures Compliance with FDA, WHO Standards Arlington, VA (February 8, 2018) The Alliance for Safe Biologic Medicines (ASBM) announced today that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA […]