U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Bevacizumab for Review
The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is
The BLA is supported by a global randomized, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin. The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression free survival and overall survival at week 18 and 42.
A total of 671 patients were randomized. At week 18, the study met the primary endpoint and the 90% confidence interval for the best ORR (objective response rate) ratio was within the pre-specified equivalence margin. The safety which included immunogenicity was found to be similar to Avastin.
Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our proposed biosimilar bevacizumab is one of the 11 biologic products being co-developed by Mylan and
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
Biocon Biologics is a subsidiary of
Forward-Looking Statements: Mylan
This press release includes statements that constitute "forward-looking statements," including with regard to the timing and outcome of clinical trials and regulatory review; the statement that the FDA acceptance of our application for proposed biosimilar bevacizumab is another important step forward to increase competition, drive health system savings and expand our growing oncology portfolio to provide a broad range of offerings; we are encouraged by the results of our scientific program to date and look forward to advancing the review of application; and once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to branded bevacizumab (Avastin) for cancer patients for the approved indications. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in
This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon
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MYLAN, Christine Waller (Media), 724.514.1968, Email: email@example.com; Melissa Trombetta (Investors), 724.514.1813, Email: InvestorRelations@mylan.com; BIOCON, Seema Ahuja (Media), +91 80 2808 2222, M:+91 9972 317792, Email: firstname.lastname@example.org; Saurabh Paliwal (Investors), +91 80 6775 2040, Email: email@example.com