The argument for the elimination of the need for phase 3 studies in biosimilars is pretty simple: They cost a great deal but what do they add to our knowledge about the safety and efficacy of biosimilars? One of the primary tasks of the Food and Drug Administration (FDA), in educating health care professionals, media, … Continue reading Phase 3 Studies in Biosimilars: Do They Tell Us Enough to Be Useful?
Tag: immunogenicity
Restating the Record on Biosimilar Safety and Efficacy
The immunogenicity and extrapolation issues are historically the greatest points of sensitivity to patients and providers. The EMA issued a report in May 2017 that summarized its findings over 10 years of biosimilar surveillance—there is no evidence of safety problems or efficacy problems with approved biosimilar products since the first licensed product.
Biosimilar Immunogenicity, Antibodies, and Extrapolation
one of the greatest concerns of physicians and patients in biosimilar development has been the potential safety of the biosimilar when it replaces an originator product. This concern is largely driven by the type of immunogenetic response the biosimilar molecule might elicit.