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Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals , including biosimilars, must maintain consistent quality and clinical performance throughout their ...
"drugs which have more or less identical clinical outcomes to pre‐existing drugs" "a drug with a similar chemical structure or the same mechanism of action as a drug that is already marketed". [1] Biosimilars are compared with other biosimilars and are therefore not me-toos. [8] [9]
Biosimilar is a term used to describe a biopharmaceutical product which seems so close in composition and effect to another that they are functionally identical, analogous to generic drugs. In this context, some publications describe "biologics" as "biosimilars". [26]
Amgen is pouring billions of dollars into biosimilar development in an attempt to capture lucrative markets enjoyed by several widely successful biologic drugs that are due to come off patent in ...
FRANKFURT (Reuters) -Novartis' generic-drugs unit Sandoz said on Monday it plans to launch a generic version of Johnson & Johnson's anti-inflammatory drug Stelara under a collaboration deal with ...
The fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase was approved for medical use in the United States in June 2020. [5] [10]The FDA's approval was based on the results of a non-inferiority study in participants with HER2-positive early breast cancer, which demonstrated the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase had comparable efficacy and ...
In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
Anytime a megablockbuster nears the end of its IP-protected life, plenty of companies will emerge to get a piece of the pie. In this case, Roche has two megablockbusters with a combined $13.5 ...