Amgen and Allergan submit Biologics License Application for ABP 798, biosimilar candidate to Rituxan® (rituximab)

AmgenAmgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA.

"The U.S. filing for ABP 798 marks an important milestone for Amgen, as it affirms our commitment to providing high quality biosimilars that offer more life-altering biological treatment options and contribute to the sustainability of healthcare systems," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with the FDA to bring ABP 798 to market."

ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is a CD20-directed cytolytic antibody that has been approved in many regions for, among other things, the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin's lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids.

"We are excited about the progress that we've made to date through our partnership with Amgen, which includes the launch of the first two oncology therapeutic biosimilars in the U.S.," said David Nicholson, Ph.D., chief research and development officer at Allergan. "With ABP 798, we look forward to the opportunity to continue to provide additional treatment options to patients suffering from serious illnesses."

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in two clinical studies. The results of these studies confirmed no clinically meaningful differences between ABP 798 and Rituxan.

Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S. and three that are approved in the European Union (EU).

About ABP 798

ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is an anti-CD20 monoclonal antibody that has been approved in many regions for the treatment of, among other things, adult patients alone or in combination with chemotherapy for non-Hodgkin's lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

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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