- The approval of a new biosimilar called Ogivri or trastuzumab-dkst by the USFDA for treatment of patients with breast and metastatic stomach cancer is based on data that proved that it is similar to the reference product, trastuzumab.
- Biosimilars are biological products that are highly similar, with no clinical differences from an existing FDA-approved reference product.
- Ogivri has been approved for all indications included in the label of the trastuzumab as it did not show any clinical differences in safety, purity and potency.
The U.S. Food and Drug Administration (USFDA) has approved its first biosimilar for the treatment of patients with HER2-positive breast or metastatic stomach cancer. Ogivri or trastuzumab-dkst is a biosimilar to the earlier approved Herceptin or trastuzumab and is only the second biosimilar ever been approved in the U.S. for the treatment of cancer.
The FDA has granted approval of Ogivri to Mylan GmbH, which is a global leader in the development and manufacturing of complex products, including biosimilar medicines.
"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, M.D. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs."
- Extensive structural and functional characterization
- Animal study data
- Human pharmacokinetic and pharmacodynamics data
- Clinical immunogenicity data
- Other clinical safety and effectiveness data that demonstrates trastuzumab-dkst is biosimilar to trastuzuma
Indications and Side effects of OgivriOgivri has been approved for treatment of patients with breast or metastatic stomach (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the human epidermal growth factor receptor 2 or HER2 gene (HER2+).
Expected side effects for Ogivri when given to HER2+ breast cancer patients may include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough and rash.
Expected side effects for Ogivri when given to HER2+ metastatic stomach cancer patients may include low levels of red blood cells, blood platelets and certain white blood cells (neutropenia), diarrhea, fatigue, weight loss, inflammation of the mouth, upper respiratory tract infections, fever, mucosal membrane swelling, and common cold.
A serious side effect of Ogivri includes worsening of chemotherapy-induced neutropenia.
Ogivri's label will include a boxed warning similar to one held for Herceptin that will mention about an increased risk of heart disease, serious allergic-like reactions, lung damage and harm to a developing fetus, the agency said.
BiosimilarsBiological products are made from many different living organisms, such as humans, animals, microorganisms or yeast. When a new biological product is approved based on data showing that it is highly similar to another biological product that has already been approved by the FDA (reference product), it is termed a biosimilar. One of the main criteria to be called a biosimilar is to have no clinically meaningful differences in terms of safety and effectiveness from the reference product.
- FDA approves first biosimilar for the treatment of certain breast and stomach cancers - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm)
- Biosimilars - (https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm)