Amgen and Allergan's MVASI™ (bevacizumab-awwb) and KANJINTI™ (trastuzumab-anns) now available in the United States

AmgenAmgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in the United States (U.S.).

MVASI, the first oncology therapeutic biosimilar approved by the U.S. Food and Drug Administration (FDA), is approved for the treatment of five types of cancer: in combination with chemotherapy for metastatic colorectal cancer (mCRC); in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; in combination with interferon-alfa for metastatic renal cell carcinoma; and in combination with chemotherapy for persistent, recurrent, or metastatic cervical cancer.

KANJINTI is FDA approved for all approved indications of Herceptin: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

"The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25% of all breast cancers," said Paula Schneider, chief executive officer, Susan G. Komen Breast Cancer Foundation. "As patient advocates, we are working to ensure that patients are educated about biosimilars and understand that these FDA-approved treatments are just as effective as the original biologic drugs."

The Wholesale Acquisition Cost (WAC or "list price") of both MVASI and KANJINTI will be 15% lower than their reference products. MVASI is being made available at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less than the WAC for Avastin. KANJINTI is being made available at a WAC of $3,697.26 per 420 mg multi-dose vial, 15% below the WAC of Herceptin. At launch, MVASI is priced 12% below the current Avastin Average Selling Price (ASP) and KANJINTI is priced 13% below the current Herceptin ASP. Both products will be available from both wholesalers and specialty distributors.

"Several years ago, Amgen made the strategic decision to invest in building a global biosimilars business, leveraging our nearly four decades of experience in developing and manufacturing best-in-class biologics," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Following several recent launches in Europe, we are excited to be launching our first two biosimilars in the U.S., which will provide for immediate savings for Medicare patients and commercial payers. We have several more biosimilars advancing through our pipeline, even as we continue to drive innovation through novel therapies for cancer and other serious diseases."

The WAC price measure does not account for discounts and rebates and may be significantly higher than out-of-pocket cost for patients, which can vary depending on several factors. Medicare and commercial insurance, for example, will generally pay for MVASI and KANJINTI based on ASP rather than WAC. Out-of-pocket cost may also depend on and be reduced by additional factors, including eligibility for patient assistance.

Actual costs to patients and providers for MVASI and KANJINTI are anticipated to be lower than WAC as WAC does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance. MVASI and KANJINTI will be available from both wholesalers and specialty distributors.

"As the first products from our collaboration with Amgen to be launched in the U.S., MVASI and KANJINTI reinforce our ongoing dedication to providing patients with additional treatment options," said David Nicholson, chief research and development officer at Allergan. "We are excited about the progress we've made through this partnership and look forward to continued milestones together with our remaining biosimilar products."

Amgen and Allergan are committed to developing high-quality biosimilars supported by robust analytical and clinical packages. MVASI and KANJINTI were proven to be highly similar to, and to have no clinically meaningful differences in terms of safety and effectiveness from Avastin and Herceptin, respectively, based on a totality of evidence, which included comparative analytical, clinical safety and efficacy data. At the time of FDA approval, KANJINTI was the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, in which a portion of patients who began the study on Herceptin made a single transition to KANJINTI. This portion of the study demonstrated similar safety and immunogenicity in patients on KANJINTI who were previously on Herceptin.

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S.

About MVASI™ (bevacizumab-awwb) in the U.S.

MVASI is a recombinant humanized monoclonal IgG1 antibody that binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.

Please see full Prescribing Information, including Boxed WARNINGS.

About KANJINTITM (trastuzumab-anns) in the U.S.

KANJINTI is a biosimilar to Herceptin, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as Herceptin. KANJINTI has the same pharmaceutical dosage form and same strength after reconstitution as Herceptin.

Please see full Prescribing Information, including Boxed WARNINGS

About the Amgen and Allergan Collaboration

In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars

Amgen is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars will help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

About Amgen Oncology

Amgen is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life - not just their cancer journey - so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including central nervous system, eye care, medical aesthetics and gastroenterology.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

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