Pennsylvania has a chance to update its law to allow for biosimilar medicine substitutions – Pittsburgh Post Gazette

July 9, 2014

See article here.

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EU Commission publishes “What you need to know about biosimilar medicinal products”

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 […]

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EU Approves First Biosimilar Insulin

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 […]

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Massachusetts Governor Signs Pharmacy Legislation Creating a Pathway for Biosimilars

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. […]

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Dr. Dolinar Presents at DIA Annual Conference

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. […]

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ASBM Shares EU Survey Results at Paris Media Briefing

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 […]

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GaBI Publishes ASBM Whitepaper on European Prescriber Survey

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 […]

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Society for Women’s Research Writes FDA on Gender Disparities Regarding Biosimilars Policies

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 […]

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Cong. Eshoo Issues Letter to FDA Requesting Status of Biosimilar Policies

May 9, 2014

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. To read letter, click here.

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ASBM Urges Delaware to Consider Biosimilars Legislation

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 […]

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