September 23, 2013
On September 23rd, in Mexico City, the International Alliance of Patients’ Organizations (IAPO) hosted a discussion on biosimilars at their Latin American Multi-Stakeholder Seminar. The meeting was attended by patient and interest groups from the region as well as ASBM Executive Director, Michael Reilly, and Global Colon Cancer Association (GCCA) Co-Executive Director, Andy Spiegel. The discussion […]
September 20, 2013
WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars. “Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “As a physician, patient safety is paramount. […]
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 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
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 24, 2013
Inside Health Policy: “Safety, Generic Concerns Factors in Proposed AMA Biosimilar Resolution” A perceived lack of safety information about biosimilars and past problems with substitution of generic drugs led neurologists and rheumatologists to ask the American Medical Association to study the safety of follow-on biologics. AMA is expected to considerer the topic further at a […]
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 21, 2013
State Legislation Update ASBM member organizations and our Advisory Board members have been actively supporting patient-focused legislation on biosimilar substitution by sending letters and testifying at hearings, particularly in California, Colorado, Florida, Indiana and Maryland. In California, SB 598, which we support, passed out of the Senate Business, Professions and Economic Development Committee hearing on […]
July 9, 2013
Testifying before Congress in April, FDA Commissioner Margaret A. Hamburg, M.D., sought to reassure lawmakers: “We are developing a science-based process for bringing safe and effective biosimilar and interchangeable products to market, which should increase competition and create substantial savings for patients, healthcare providers, and insurers.” More than a year after issuing three draft guidances […]
