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
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.
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 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 […]
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 […]
April 2, 2014
ASBM member Global Healthy Living Foundation (GHLF), recently produced an educational video highlighting the need and importance of unique names for biosimilars. The video includes perspectives from Steve Marmaras of GHLF; Donna Cryer a prominent patient advocate who uses biologics; former FDA official Peter Pitts; as well as ASBM executive director Michael Reilly and RetireSafe […]
March 25, 2014
Arlington, VA – Today, the Alliance for Safe Biologic Medicines (ASBM) applauds Governor Mike Pence of Indiana in signing legislation to ensure the safe substitution of interchangeable biologic medicines, approved by the Food and Drug Administration (FDA). “We commend Indiana in taking the lead to make patient safety the priority as life-altering biologics become more […]
March 18, 2014
Brussels — Today, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in Q3 of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the […]
