August 15, 2013
This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars. The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.
July 29, 2013
Recommendation marks extension of biosimilar concept to new product class The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars. Remsima and Inflectra both contain the same known active substance, infliximab. In the application dossiers, they have been shown to be similar to the biological medicine Remicade, a […]
July 25, 2013
ASBM continues to participate in and lead forums across the country to educate patients, physicians, pharmacists and policymakers on the U.S. Food and Drug Administration’s (FDA) efforts to bring biosimilars to patients in the U.S. The intent of the campaign is to highlight the complex nature of biologics, the precise methods and processes required to […]
July 25, 2013
On May 2, 2013, in Geneva Switzerland, the International Alliance of Patients’ Organizations (IAPO) hosted a gathering of 21 health consumer organizations for a workshop on biosimilar medicines. Executive Director of ASBM, Michael Reilly, Andrew Spiegel, Co-Chair of the Global Colon Cancer Alliance and Stephen Murby, Board Member of Consumers Health Forum in Australia participated […]
July 25, 2013
June 26, 2013 In Ottawa, Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability,” hosted by Health Canada and BIOTECanada. Dolinar’s presentation added a physician’s perspective to the emerging consensus that […]
July 25, 2013
June 24, 2013 Speaking at the 49th Annual Drug Information Association (DIA) Conference in Boston, Richard Dolinar, M.D., presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality […]
July 22, 2013
State Legislation Update Several state legislatures have have adjourned for the year, but we continue to urge support for California Senate Bill 598, which passed off the Senate Floor (29-4) on Friday, May 24. The bill now heads to the State Assembly where it is expected to be double-referred to the Assembly Business, Professions and […]
July 1, 2013
Ottawa, ONTARIO – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26 and 27. Dolinar’s presentation added a physician’s perspective to the […]
June 27, 2013
WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership. EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio […]
May 22, 2013
In 1988, I became extremely ill. I had many tests, saw many doctors and was given various medicines. Some caused allergic reactions. Through it all, I remained sick — and actually became worse. Eventually, I was diagnosed with autoimmune hepatitis, a very rare disorder. Much of the information I read said I had about 10 […]
