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FDA clears Mylan's Herceptin biosimilar; Roche hopeful

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By Randy Osborne
Staff Writer

The FDA has given Mylan NV the go-ahead for its Ogivri (trastuzumab-dkst), a biosimilar to Roche AG's blockbuster breast cancer therapy Herceptin (trastuzumab), for patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene.

Ogivri represents the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second approved in the U.S. for cancer, regulators noted. In September, Thousand Oaks, Calif.-based Amgen Inc. won clearance for Mvasi (bevacizumab-awwb), a biosimilar to treat all eligible indications of the reference product Avastin (bevacizumab), from Basel, Switzerland-based Roche's Genentech unit. Five of the six indications included in the approval were extrapolated. Mvasi was tested in non-squamous, non-small-cell lung cancer, but it also was approved for first- or second-line treatment in metastatic colorectal cancer, second-line treatment for metastatic colorectal cancer in patients who have progressed on a first-line bevacizumab-containing regimen, glioblastoma, metastatic renal cell carcinoma and cervical cancer. (See BioWorld, Sept. 15, 2017.)

The clearance of Ogivri was based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that prove Ogivri qualifies as a biosimilar to Herceptin, the FDA said, pointing out that the compound from Hatfield, U.K.-based Mylan gained as a biosimilar and not as an interchangeable product. Herceptin won the FDA's blessing in 2010.

Jefferies analyst Jeffrey Holford, in a report last month, referred to "increasing biosimilar erosion" faced by Roche. Still, the company "spoke with enthusiasm about their portfolio rejuvenation plans as they look to offset" the problem, he said. His firm held a "fireside chat" in London with company officials. "In addition to their plans to replace and extend their HER2 breast cancer and hematology franchises, they outlined their strategy for their key new franchises and therapeutic areas such as immuno-oncology, multiple sclerosis, and hemophilia A.

Last month, well ahead of the assigned Feb. 23, 2018, PDUFA date, the FDA approved Hemlibra (emicizumab-kxwh), a bispecific monoclonal antibody that brings together factors IXa and X to mimic the role of factor VIII (FVIII) and restore blood clotting, as a therapy to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A who develop FVIII inhibitors.

The product was advanced by Genentech unit in collaboration with Chugai Pharmaceutical Co. Ltd., of Tokyo, which discovered the asset. Almost one in three people with severe hemophilia A can develop inhibitors to FVIII replacement therapies.