I38. BIOLOGICS AND SAFETY ISSUES GUIDELINE

Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity

US health care reform includes an abbreviated pathway for follow-on biologics, also known as biosimilars, in an effort to speed up access to these complex therapeutics. However, a key patient safety challenge emerges from such an abbreviated pathway: immunogenicity reactions. Yet immunogenicity is notoriously difficult to predict, and even cooperative approaches in licensing between companies h...

Safety Issues of Mobile Phone Base Stations

Book review: Safety of Biologics Therapy

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Quality, safety and efficacy of follow-on biologics in Japan.

Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are partially different. Differences have been noted in the requirements for comparability studies on stability, prerequisites for reference product, or for the...

Current challenges and opportunities in nonclinical safety testing of biologics.

Nonclinical safety testing of new biotherapeutic entities represents its own challenges and opportunities in drug development. Hot topics in this field have been discussed recently at the 2nd Annual BioSafe European General Membership Meeting. In this feature article, discussions on the challenges surrounding the use of PEGylated therapeutic proteins, selection of cynomolgus monkey as preclinic...