BioSim represents the national pharmaceutical companies that develop, manufacture, market or distribute this type of biological drug
Amgen has one of the broadest biosimilar pipelines in the industry and already has marketing authorization from the European Medicines Agency for AMGEVITA® (adalimumab biosimilar)
BaBarcelona, June 8, 2017. The biotechnological pharmaceutical company Amgen has joined the Spanish Association of Biosimilars (BioSim), to which 16 companies already belong, and whose main objective is to improve knowledge of biosimilar drugs by professionals, health organizations and patients, as well as promote regulatory mechanisms that facilitate their use and adequate presence in therapeutic decisions.
Amgen, with almost 40 years of history in the research and development of innovative biological drugs, has also made a firm commitment to the sustainability of the healthcare system, producing high-quality biosimilars with the aim of improving patient access to biological therapies, expanding the options available and promoting competition. The North American company already has one of the most important pipelines of biosimilars in development in the world.
In the coming years, Amgen plans to launch up to six biosimilars, specifically adaluimumab (Humira®); infliximab (Remicade®), trastuzumab (Herceptin®), bevacizumab (Avastin®), rituximab (Rituxan®/MabThera®), cetuximab (Erbitux®), and three more that have not been disclosed at this time.
“All the knowledge that we have acquired throughout our history in the development and production of innovative biological drugs is now also at the service of the manufacture of biosimilars, for which we will maintain the high quality standards that characterize Amgen”, explains Roman. Stampfli, CEO of Amgen Iberia.
Amgen also has the guarantee and confidence of never having suffered a supply problem, given its production and supply capacity.
"The incorporation of a new associate of the importance of Amgen is very encouraging news, and it strengthens us even more as a reference in the sector", says Regina Múzquiz, general director of BioSim. “I am sure that Amgen will find in BioSim a channel to further improve its ability to offer high-quality and highly effective biological medicines, available to patients, professionals and health organizations,' adds Múzquiz.
In addition to the nine biosimilars in development, the US company has a robust pipeline of more than 50 innovative molecules, most with clinical targets that have not been tried before. Almost half of those molecules have unique and innovative mechanisms of action.
Primer biosimilar in Europe
Amgen has already obtained authorization to market its first biosimilar in Europe. AMGEVITA® (adalimumab biosimilar, Humira®) has been approved for the treatment of certain inflammatory diseases in adults, including moderate to severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); severe axial spondyloarthritis without radiographic evidence of AD; moderate to severe chronic plaque psoriasis; moderate to severe hidradenitis suppurativa; noninfectious intermediate and posterior uveitis and panuveitis; moderate to severe Crohn's disease and moderate to severe ulcerative colitis.
In addition, the European Commission has also authorized AMGEVITA® for the treatment of certain pediatric inflammatory diseases, such as moderate to severe Crohn's disease; severe chronic plaque psoriasis; arthritis associated with enthesitis; and polyarticular juvenile idiopathic arthritis.
Acerca of Amgen Biosimilars
Amgen Biosimilars leverages all of Amgen's experience in developing and manufacturing innovative biologics to provide more treatment options for patients with serious illnesses. Biosimilars will help uphold Amgen's commitment to connecting patients with key medicines for improvement and/or cure. Nearly 40 years of experience in the biotechnology industry uniquely position Amgen to create high-quality biosimilars and deliver them reliably to patients around the world.
Acerca of amgen
Amgen is the world's first independent biotech company. Since its birth in California (United States) in 1980, it has been committed to harnessing the full potential of biology to discover, develop and produce innovative human treatments for patients suffering from serious diseases. This approach begins with the use of tools such as advanced human genetics to uncover the complexities of pathology and understand the fundamentals of human biology.
Focused primarily on the areas of oncology, cardiology, hematology, bone metabolism, nephrology and neurosciences, Amgen has reached millions of patients worldwide with its drugs and continues to develop a portfolio of innovative medicines to further contribute to the health and well-being of the population.
Meritxell mir
DDirector of Communication mmirbara@amgen.com