July 9, 2014
Translations of the European Commission’s Consensus Information Document on biosimilars is now available in French, German, Italian and Spanish. The documents were created to foster stakeholders’ understanding of biosimilars in Member States and is a result of a cooperation of all relevant European stakeholders. The papers can be found on the European Commission’s website. Also to learn more […]
July 1, 2014
On June 27, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced granting of preliminary marketing approval for the European Union’s first biosimilar insulin glargine product. Called Abasria (LY2963016), the investigational basal (long-acting) insulin is intended for the treatment of type 1 and type 2 diabetes. Abasria, like its reference product, the […]
June 24, 2014
Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts. […]
June 24, 2014
Arlington, VA – Today, Governor Deval Patrick enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed ‘interchangeable’ by the Food and Drug Administration (FDA). The Governor took such action after swift passage of HB 3724 in both chambers of the General Court of the Commonwealth of Massachusetts. […]
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 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 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 […]
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 […]
