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Development and production of biosimilars at Amgen.
Our story holds over 40 years of experience in developing
innovative biologic therapies, which are made from living cells
enhancing our development of biosimilars in different therapeutic areas
around the world, such as inflammation and oncology
Biosimilars are biologic medicines designed to work
just like another FDA approved medicine,
known as the reference product, and are tested to ensure they are safe,
effective and highly similar to the reference product.
Since the first biosimilar was approved in Europe in 2006,
Amgen has developed one of the world’s largest biosimilars portfolios
Providing effective and safe treatments for patients and healthcare systems
More than 750,000 people in more than 65 countries
have been prescribed Amgen’s biosimilars to date
Every patient
Every time
Amgen is committed to developing high-quality biosimilar medicines for patients. Amgen was one of the first large-scale biotechnology manufacturers, and we have developed some of the most widely used, quality biologic medicines used in the treatment of millions of patients around the world.
A biosimilar is a biologic medicine that is highly similar to an approved biologic medicine, known as the reference biologic or reference medicine.4
To be approved, a biosimilar must show it has no clinically meaningful differences to the reference biologic in terms of quality, safety, and its ability to produce the desired outcome in patients (also known as efficacy)5,11.
At Amgen, our biosimilar medicines are manufactured with the same high degree of quality as any of our biologic medicines8. Like all biologics, testing is performed during the manufacturing process to assess biosimilar quality.
Amgen has been a biotechnology innovator since 1980. We have been steeped in this challenging field since the early days of recombinant DNA technology, when a handful of scientists and investors came together to prove the promise of innovative biotechnology.
We are leaders in the development of treatments across six therapeutic areas: oncology and hematology, cardiovascular disease, nephrology, inflammation, bone health, and neuroscience.
At Amgen, our mission has always been to develop treatment options that improve outcomes and help patients live fuller lives.
Extrapolation is used to support the approval of a proposed biosimilar product in one or more additional indications for which the reference product is licensed, but for which the biosimilar has not been studied in clinical trials.7
Extrapolation has the potential to reduce or eliminate the need to study a proposed biosimilar with clinical trials in every indication of the reference product. But it is not an automatic process. It is based on all available data in the biosimilar application and a regulatory body like FDA’s previous findings of safety and efficacy of the reference product’s approved indications.7
Developing a biosimilar is a complex process. Biosimilars, like all biologics, are produced through an intricate, multistep process, using living cells. However, the cell line and manufacturing process of the reference product are proprietary and belong to the original manufacturer. Biosimilarity can be established through evaluation of the biosimilar in various experiments and testing including active comparator clinical trials, in comparison to the reference biologic.1-4
At Amgen, we excel at the highly specialized, iterative process of developing monoclonal antibodies in vitro, scaling up the optimal cell line, time and again, in large-scale bioreactors, and checking and rechecking for batch-to-batch consistency.2,6
At Amgen, we make medicines for serious illnesses and chronic conditions that deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.
Manufacturers of biologic medicines are responsible for monitoring all steps during product development and manufacturing to ensure that the medicine is pure, has the desired strength and is stable.2 A reliable supply chain is key to this responsibility. Biosimilar supply chains should: