June 19, 2014
On June 19th, ASBM Chairman Richard Dolinar, MD presented at the Drug Information Agency’s (DIA) 50th Annual Meeting in San Diego, California. “Trends in Biosimilars Regulation Within Developed and Emerging Markets” was an assessment of current debates within the regulatory landscape of biosimilars. Dr. Dolinar participated on a panel moderated by Andrew Robertson, Director of U.S. […]
June 10, 2014
Michael Reilly, Executive Director of the Alliance for Safe Biologic Medicines, (ASBM) was featured as an expert panelist at “Understanding Biologic Medicine: Science, Regulatory Policy and the Changing Dynamics of Biosimilars”, a media briefing hosted by AbbVie on June 10th in Paris, France. The two-part event was webcast worldwide and featured a discussion on the […]
June 6, 2014
GaBI Publishes ASBM Whitepaper on European Prescriber Survey On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly. The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics […]
June 5, 2014
On June 5, The Generics and Biosimilars Initiative Journal published a paper authored by ASBM’s Chairman Richard Dolinar, MD and its Executive Director Michael Reilly. The paper is based on data collected by ASBM for its 2013 survey of 470 prescribing physicians with clinical experience using biologics and biosimilars. Respondents included specialists from five Western […]
May 21, 2014
In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWRA) along with over 40 other organizations, asked the FDA to consider gender disparities when it comes to biosimilars policies. SWHR states: “As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the […]
May 9, 2014
Lawmaker Presses FDA for Guidance on Naming, Interchangeability Policies In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability. “I believe clear and timely guidance on naming and interchangeability will allow both innovators and manufacturers […]
May 8, 2014
The Alliance for Safe Biologic Medicines and other ASBM patient groups continue to write the Delaware House of Representatives requesting passage of Senate Substitute 1 for SB 118 regarding biosimilar products. A vote in the full House is expected Tuesday, May 13. Letters to House of Representatives requesting final passage. View AARDA letter here. View […]
April 23, 2014
ASBM Executive Director, Michael Reilly joined Kimberly Greco of Amgen and Christopher Mikson, MD of Jones Day for a biologics panel at the Food and Drug Law Institute’s (FDLI) 57th Annual Conference on April 23rd in Washington, DC. The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview […]
April 8, 2014
Geneva — ASBM was invited to share its perspectives before the World Health Organization’s 58th International Nonproprietary Names Consultation for Pharmaceutical Substances, Open Session for Stakeholders. At the meeting, ASBM Chairman Richard Dolinar, M.D., shared the results of a recent ASBM survey of European Physicians that concludes using the same INN for different biologic medicines […]
March 31, 2014
ASBM Releases EU Physicians’ Survey in Brussels On March 18th in Brussels, the Alliance for Safe Biologic Medicines (ASBM) released the results of a survey of 470 European physicians from five countries regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, […]
