Senate HELP Committee authors letter to HHS Secretary on biosimilars issues
August 1, 2014
View letter here.
August 1, 2014
View letter here.
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 […]
July 9, 2014
See article here.
July 9, 2014
See article here.
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. […]