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ASBM in Brazil

ASBM has traveled to cities around the world to participate in regulatory discussions on how to best achieve global safety standards for biosimilars. In August 2014, ASBM representatives took part in several meetings in Rio de Janeiro, Brazil for two different conferences.

ASBM Chairman Dr. Harry Gewanter was a guest speaker at the August 13 “4th Latin America Forum on Biosimilars” where he gave a presentation on interchangeability. He explained the current legislative landscape in the U.S. and highlighted that:

  • It is important to physicians that they retain the authority to use “do not substitute” to ensure the patient receives their chosen medicine
  • It is important to physicians that they are informed in a timely fashion of the medicine(s) the patient receives and if it is different than what they prescribed
  • Distinguishable INNs are important to the practicing physicians in the U.S. and Europe

View his presentation here.

Ten days later, Global Colon Cancer Association Executive Director, Andrew Spiegel participated in the International Alliance of Patients’ Organizations (IAPO) “Increasing the Patient voice in drug regulatory Authorities” meeting in Rio de Janeiro and then presented at the “Pre-International Conference of Drug Regulatory Authorities” on August 24. In his presentation, Spiegel highlighted the need for distinguishable nonproprietary names as a means of keeping patients safe. He urged support for the WHO BQ proposal, which lays the groundwork for creating consistent global policies on naming.

View his presentation here.