ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum.
First Avastin® (Bevacizumab) Biosimilar Candidate Recommended for European Approval |
| [10-November-2017] |
| THOUSAND OAKS, Calif., Nov. 10, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan (NYSE:AGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, a biosimilar to Avastin® (bevacizumab). ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix. “ABP 215 has the potential to provide healthcare professionals and appropriate patients across Europe access to high-quality, targeted cancer therapy,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The positive CHMP opinion for ABP 215 marks the first time a bevacizumab biosimilar has been recommended for approval in the European Union, which is an exciting milestone for Amgen.” Amgen and Allergan are committed to developing high-quality biosimilars with a robust analytic and clinical package. The Marketing Authorization Application for ABP 215 was based on a comprehensive data package that demonstrated ABP 215 and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase 3 trial in patients with non-squamous NSCLC. “This positive opinion underscores our commitment with Amgen to bringing biosimilars to market to help patients with difficult-to-treat cancers,” said David Nicholson, chief research and development officer at Allergan. “We are encouraged by the progress Amgen and Allergan have made in developing biosimilars in critical disease areas and look forward to providing important medicines to patients in the future.” The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC. In September 2017, ABP 215 became the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, to be approved by the U.S. Food and Drug Administration (FDA). It is approved in the U.S. with the brand name MVASI™ (bevacizumab-awwb). Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which has been approved by the EC. About ABP 215 in the European Union About MVASI (bevacizumab-awwb) in the U.S. MVASI is indicated for the treatment of metastatic colorectal cancer (mCRC), with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. MVASI is indicated for the treatment of mCRC, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen. MVASI is not indicated for adjuvant treatment of colon cancer. MVASI is indicated for the treatment of non-squamous NSCLC, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease. MVASI is indicated for the treatment of glioblastoma, as a single agent for adult patients with progressive disease following prior therapy. The effectiveness of bevacizumab products in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab products. MVASI is indicated for the treatment of metastatic renal cell carcinoma with interferon alfa. MVASI is indicated for the treatment of cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease. MVASI is currently not available commercially. This is not an offer for sale. The following information is derived from the approved label in the U.S. MVASI U.S. Important Safety Information Boxed WARNINGS Gastrointestinal (GI) Perforations Surgery and Wound Healing Complications Hemorrhage Additional serious adverse events
Pregnancy warning
Most Common Adverse Events
Please see full Prescribing Information, including Boxed WARNINGS, at www.Amgen.com. About the Amgen and Allergan Collaboration About Amgen Biosimilars For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim. About Amgen’s Commitment to Oncology About Amgen Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Forward-Looking Statements No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between it and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. Amgen’s stock price may be volatile and may be affected by a number of events. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Avastin® is registered trademark of Genentech. CONTACT: Amgen, Thousand Oaks Amgen, Europe CONTACT: Allergan plc.
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Company Codes: NASDAQ-NMS:AMGN, NYSE:AGN |
