By Andrew Williams --
Earlier today, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple types of cancer. This marks the first time that a biosimilar for the treatment of cancer has been approved by the FDA. According to the FDA's press release, Mvasi was approved for the following indications in adult patients:
• Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
• Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
• Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
• Metastatic renal cell carcinoma, in combination with interferon alfa.
• Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
FDA Commissioner Scott Gottlieb, M.D., indicated that the FDA would "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." As apparent evidence of this commitment, Amgen's biosimilar application was filed last November, and accepted by the FDA for review on January 4, 2017 (according to a complaint filed by Genentech in Delaware last February). This means that the FDA approved this aBLA in less than nine months from the acceptance of the application.
Interestingly, there is currently no litigation pending that could prevent Amgen from launching its new biosimilar drug product. Even though Amgen had disclosed its aBLA pursuant to the BPCIA, Genentech did file the aforementioned complaint to force Amgen to provide Genentech with manufacturing information allegedly not found in the aBLA. Genentech had provided Amgen with a written request for information related to, among other things, the host cells used to manufacture the drug, the composition of the cell culture media, the extent and nature of the glycosylation patterns of the drug, the transformation of the culture cells, the sparging of the culture fluid, the Protein A chromatography purification process, any cation or anion exchange chromatography used to purify the drug, any viral inactivation steps, all formulations considered or used, and the filling of vials and/or the use of tangential flow filtration. Amgen apparently took the position that it had satisfied its obligation under 42 U.S.C. § 262(l)(2)(A) by providing the aBLA. The Court agreed that Genentech could not obtain relief, granting a 12(b)(1) motion filed by Amgen to dismiss the case for lack of subject matter jurisdiction in light of the Federal Circuit's holding in Amgen v. Sandoz. No subsequent litigation has yet been filed, so it is unclear whether the Patent Dance has occurred notwithstanding the alleged disclosure deficiency.
Mvasi is the seventh biosimilar application to be approved by the FDA, and the second in less than a month. In late August, the FDA approved Boehringer Ingelheim's aBLA for Cyltezo (adalimumab-adbm), a biosimilar to Abbvie's Humira® (see "Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for CyltezoTM (adalimumab-adbm), a biosimilar to Humira®, for the treatment of multiple chronic inflammatory diseases"). This was the second approved biosimilar to this reference product, and the first biosimilar approval obtained by Boehringer Ingelheim. Nevertheless, just as with Amgen's approved Humira® biosimilar, concurrent litigation will likely keep Cyltezo off the market for the foreseeable future.
We will continue to monitor these situations and report any updates as warranted.