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First Oncology Biosimilar Approved in US: Bevacizumab

The US Food and Drug Administration (FDA) has approved the first biosimilar for use in oncology ? the product is Mvasi (bevacizumab-awwb), from Amgen.

It is equivalent to the reference product, Avastin (Genetech/Roche), which was first approved in the United States in 2004.

Like the reference product, the biosimilar bevacizumab is approved for use in several types of cancer, including metastatic colorectal cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma, cervical cancer, and glioblastoma.

The term "biosimilar" means that the agent has the same efficacy and adverse effect profile as the reference product. The main difference will be in price ? biosimilars are expected to be cheaper, and so bring down the cost of treatment.

At the recent European Society of Medical Oncology meeting, experts said the price of biosimilars is expected to be about 30% lower than that of reference products.

The FDA noted the potential for cost reduction in its announcement.

"Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies," said FDA Commissioner Scott Gottlieb, MD.

The agency also explained: "A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (ie, safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law."

The FDA's approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate that Mvasi is biosimilar to Avastin.

The agency emphasized that it has been approved as a biosimilar, not as an interchangeable product.

Biosmilar bevacizumab and also bisosimilar trastuzumab (equivalent to Herceptin, Genentech/Roche) were discussed in great detail at a recent meeting of the Oncology Drugs Advisory Committee (ODAC), as reported by Medscape Medical News. All the committee members voted in favor of recommending the biosimilar products for approval; there were no votes against, nor were there any abstentions.

Details of the Indications and Adverse Events

The new biosimilar bevacizumab has indications similar to those of the reference product, with specific details on the chemotherapy combinations that can be used in each cancer type.

In metastatic colorectal cancer, the product is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment, and in combination with fluoropyrimidine-irinotecan-based or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who experience disease progression on a first-line bevacizumab product-containing regimen. The agency makes a point of noting that Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.

For NSCLC, the product is indicated for use in combination with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease.

For cervical cancer, the product is indicated for use in patients who have disease that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

For glioblastoma, the product is approved for use in patients with progressive disease following prior therapy, based on improvement in objective response rate. However, the agency notes that there are no data to show an improvement in disease-related symptoms or survival with bevacizumab products.

The FDA also details the adverse events that can be expected with the biosimilar, as can be expected with the reference product.

Common expected side effects include nose bleeds (epistaxis), headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal bleeding, lacrimation disorder, back pain, and skin irritation (exfoliative dermatitis), the agency notes.

Serious expected side effects include perforation or fistula, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria, and ovarian failure. Patients should stop using Mvasi if these side effects become severe or life-threatening, the agency warns.

The FDA also points out that, like the reference product Avastin, the labeling for the biosimilar product Mvasi contains a boxed warning to alert healthcare professionals and patients about an increased risk for gastrointestinal perforations; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal hemorrhage. Patients should stop using Mvasi if gastrointestinal perforation occurs. Patients should not take Mvasi in the 28 days prior to and after elective surgery, and until the surgical wound is fully healed. Patients should stop using Mvasi if a surgical incision breaks open (wound dehiscence). Mvasi should not be given to patients with severe hemorrhage or hemoptysis.

First Oncology Biosimilar Approved in US: Bevacizumab - Medscape - Sep 14, 2017.


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