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Biosimilar to Herceptin Is Approved and Neulasta biosimilar does well in studies.
Cancer patients may have more choice with their medications in the near future, as the FDA approved the first biosimilar to Herceptin (trastuzumab) for treating breast cancer and metastatic stomach cancer. In addition, a biosimilar to Neulasta (pegfilgrastrim), which boosts the white blood cell count during chemotherapy, garnered some positive Phase 1 study results.
This month, the FDA approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin for patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Genentech, the maker of Herceptin, retains the exclusive license to market the drug for metastatic gastric cancer. Trastuzumab-dkst was co-developed with Biocon.
Ogivri is the first biosimilar approved in the United States for treatment of breast cancer or stomach cancer and the second biosimilar approved for cancer. In September, FDA approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for colorectal cancer.
“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, MD. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
The FDA’s approval of Ogivri is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic (PK) and pharmacodynamic (PD) data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin.
Meanwhile, Sandoz reported that data from a Phase 1 study confirmed that its biosimilar pegfilgrastim matches the reference biologic, Amgen’s Neulasta, in terms of PK, PD, and immunogenicity profiles. The data were presented at the 2017 San Antonio Breast Cancer Symposium.
In the Phase 1 study, Sandoz’s pegfilgrastim matched the reference medicine in the PK and PD comparisons as primary endpoints in terms of absolute neutrophil count (maximum effect attributed to study medication) and maximum serum concentration of study medication after administration. The secondary endpoints of safety and immunogenicity were comparable between both groups.
Biosimilars to Neulasta have the potential for blockbuster sales, as Neulasta netted $4.6 billion in sales for Amgen last year - primarily in the United States, FiercePharma reported.
There is increasing competition in the biosimilar cancer market as Mylan and Biocon are also developing a biosimilar to Neulasta, Reutersreported.
Meanwhile, Sandoz’s biosimilar of pegfilgrastim is currently under review by the European Medicines Agency for the same indication as Neulasta.