Senator Hagan writes HHS to issue guidance on naming
July 30, 2014
View letter here.
Latest News
ASBM member RetireSafe conducts senior survey on knowledge and safety issues concerning biosimilars
July 18, 2014
A new RetireSafe survey, published July 15th, finds seniors largely are unaware of “biosimilar” drugs and overwhelmingly support strong patient safeguards for biosimilar development and FDA approval. In the survey, senior respondents supported robust clinical trials, unique names for biosimilar drugs, as well as physician and patient notification of biosimilar substitution. To view the RetireSafe […]
Pennsylvania has a chance to update its law to allow for biosimilar medicine substitutions – Pittsburgh Post Gazette
July 9, 2014
See article here.
Pennsylvania has a chance to update its law to allow for biosimilar medicine substitutions – Pittsburgh Post Gazette
July 9, 2014
See article here.
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 […]
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 […]
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. […]
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. […]
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. […]
