November 15, 2013
The Alliance for Patient Access (AfPA) held their National Physicians Biologics Working Group Meeting on November 15-16 in Chicago, IL where Dr. Dolinar gave the keynote address to attending physicians. In his address, Dr. Dolinar discussed the current state of biosimilars and explained the disconnect between the science and potential policies and how they will impact […]
November 7, 2013
InsideHealthPolicy’s FDA Week an exclusive weekly report on Food and Drug Administration policy, regulation and enforcement From Vol. 19, No. 44, November 1, 2013 BIO Disagrees With Lawmakers, Says ACA Left Biosimilar Naming To FDA The innovator biologics industry disagrees with a bipartisan group of senators’ view that FDA would violate congressional intent if it […]
August 26, 2013
ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO. The second letter is a result of ASBM’s keen interst in the […]
August 26, 2013
ASBM Chairman Richard Dolinar, MD recently submitted another letter on naming to the World Health Organization Director-General, Dr. Margaret Chan, as well as the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation division at WHO. The second letter is a result of ASBM’s keen interst in the […]
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 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
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 […]
