Regulatory Pathway for 3D Printing.

Abstract

The FDA recently approved the first biosimilar for patients with certain breast or stomach cancers. Marketed as Ogivri, trastuzumab-dkst is the second biosimilar approved in the United States to treat cancer. Trastuzumab-dkst is biosimilar to trastuzumab, a monoclonal antibody that was approved in 1998 and is sold under the brand name Herceptin. The newly approved biosimilar is indicated for patients with breast or metastatic stomach tumors that are ERBB2 (formerly human epidermal growth factor receptor 2 [HER2] or HER2/neu) positive. By approving more biosimilar drugs, FDA Commissioner Scott Gottlieb, MD, said the agency hopes to promote competition that may help lower health care costs. “This is especially important when it comes to diseases like cancer that have a high cost burden for patients,” Gottlieb said in a statement. A recentanalysis estimated thatbiosimilarswill cutdirect spendingonbiologicdrugs by $54 billion between 2017 and 2026. Biological products generally are derived from living systems—humans, animals, microorganisms, or yeast, for example. Drugmakers that develop biosimilars must showthat theirproductsarehighly similar to the biologic drug uponwhich they’re based. Biosimilars can have no meaningful clinical difference fromtheoriginalproduct in terms of safety, purity, and potency. Approvalof trastuzumab-dkstwasbased on the FDA’s review of evidence that included extensive structural and functional characterizationanddatagatheredfromanimal studies, pharmacokinetic evaluations in patients and healthy individuals, and clinical immunogenicity studies. The evidence showed that trastuzumab-dkst is biosimilar to but not interchangeable with trastuzumab. Interchangeable products must meet additional FDA requirements and can be substituted for the original formulation without a prescriber’s approval. Aboxedwarningcautionsphysiciansand patients that trastuzumab-dkst may increase the risk of cardiomyopathy, pulmonarytoxicity,andembryo-fetal toxicity.More common adverse effects include headache, diarrhea, nausea, chills, fever, infection, and congestive heart failure.

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