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FDA approves Mvasi, first biosimilar for cancer
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The FDA today approved the first biosimilar for cancer — bevacizumab-awwb — to treat patients with multiple types of cancer.
Bevacizumab-awwb (Mvasi, Amgen) — a biosimilar to bevacizumab (Avastin, Genentech) — is indicated for patients with:
- metastatic colorectal cancer, in combination with IV 5-FU-based chemotherapy for first- or second-line treatment;
- metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment of patients who have not progressed on first-line treatment containing bevacizumab;
- unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment;
- glioblastoma that progressed following prior therapy;
- metastatic renal cell carcinoma, in combination with interferon alfa; and
- persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin or topotecan.
The FDA noted bevacizumab-awwb is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
Further, the indication for glioblastoma is based on improvement in objective response rate, because no data are available to show improvement in symptoms or survival for this setting.
“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,” FDA commissioner Scott Gottlieb, MD, said in a press release. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”
A biosimilar is a biological product — which is derived from a living organism such as humans, animals, microorganisms or yeast — that is approved based on data showing it is highly similar to an already-approved biological product. The biosimilar must show no clinically meaningful differences in safety, purity and potency from its reference product.
FDA based the approval of bevacizumab-awwb on a review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and clinical safety and efficacy that demonstrated its similarity with reference bevacizumab.
Adverse events associated with bevacizumab-awwb include epistaxis, lacrimation, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. Serious adverse events include perforation or fistula, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria and ovarian failure.
The FDA approved bevacizumab-awwb with a boxed warning regarding the increased risk for gastrointestinal perforations; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal hemorrhage.
Perspective
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Jai N. Patel, PharmD
The FDA approval of Mvasi is a great stride for biosimilar approval in the United States and will, hopefully, set precedence for the dozens of other anticancer biosimilars in development. The United States is far behind biosimilar approval compared with Europe. Although the individual cost savings of biosimilars vs. branded products — a 20% to 25% savings — is incremental compared to brand vs. generic for small molecule drugs, which show an 80% to 90% savings, the additive cost savings on products that typically cost well over $100,000 per year can have a significant impact on the overall value of health care, up to several hundred billion dollars over the next decade. Further, one can hope the downstream effect of the first FDA-approved biosimilar for cancer will result in increased price competition, which will obviously lower health care costs and increase drug access.
It is important to note that Mvasi is not approved as an interchangeable product and, therefore, cannot be automatically substituted. The FDA has taken a rigorous stepwise approach to approving biosimilars. As a clinician, I feel comfortable that these medications will produce the same clinical outcomes, including both efficacy and safety, as the originator product. As clinicians become more accustomed to using biosimilars — such as filgrastim-sndz (Zarxio; Sandoz, Novartis) — and postmarketing surveillance grows, more and more clinicians will feel comfortable prescribing biosimilars, and the downstream impact will result in immediate cost savings and increased drug access to cancer patients who are in dire need of cheaper drugs, even if it is by 20% to 25%. Nonetheless, providers must remain vigilant about using biosimilars, understand the risk and benefits, and pay close attention to post-marketing data.
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