Since 1980, Amgen has been at the forefront of biotechnology, helping invent the processes and tools that built the global biotechnology industry into the leading source of therapies for patients with few other options.
Over the last four decades, Amgen has developed a range of innovative therapies focusing on biologic medicines. Our expertise in biologics is now being applied into developing high quality, therapeutic biosimilars in order to deliver more value to both patients and healthcare systems.
Biologics are protein-based therapies that are produced in unique, specially modified cell lines.1 Simple biologics include recombinant proteins and hormones whereas monoclonal antibodies are much larger, and more complex in structure. Biologics are therefore more complex to develop and manufacture than chemical drugs.
191 amino acids
Monoclonal antibodies (mAb)
~1,300 amino acids
|Generic||Small Biologic||Large Biologic|
|Same Structure||Highly Similar Structure|
A biosimilar is a biological medicine that is similar to another biologic that has already been authorised for use.1 Biosimilars are not generics and therefore not identical to the reference product nor to each other. Each represents a unique treatment option for patients.
The development of biosimilars2 is more complex than that of generics given the inherent complexity of biologics. Biologics are produced in living cells and are more complex in structure than traditional small-molecule medicines. As proteins that are produced in living organisms, biosimilars are very sensitive to manufacturing conditions
|Characteristics of Biopharmaceuticals vs Traditional, Small-Molecule Generics|
|Complex proteins||Simple molecular structure|
|Large sizes: up to 100-1000 times larger than traditional generics||Small size|
|Genetically modified living cells||Chemical manufacturing process|
|Multifaceted manufacturing process||Minimal steps to synthesize product, process easily duplicated|
|Complex mechanisms of action||Simple, direct mechanism of action|
|Multiple targets, binding sites||Well-characterized binding sites|
|Efficacy markers not always clear||Efficacy markers easily quantified|
|Hard to isolate, purity after production||Product components limited, know|
|Generally unstable||Stable once produced|
Amgen is delivering value and sustainability by developing innovative medicines and biosimilars.
The availability of biosimilars offers patients, physicians and payers a greater choice in treatment options. Biosimilars are cheaper than their reference product, with the extent of the savings depending on the product. Their greater affordability could make therapies more widely accessible to patients.1
Through cost savings, biosimilars can play a key role in promoting the sustainability of healthcare systems, by freeing healthcare resources that can be reinvested in innovative therapies and so contribute to on-going pharmaceutical innovation2. In addition, through cost savings, biosimilars support one of the World Health Organisation’s top priorities, which is to increase patient access to medical products.3
The European Union was the first to establish a regulatory approval pathway for biosimilars in 20051, with the first biosimilar being approved in 20062. Since then, the European Union has accumulated vast experience on the use and safety of biosimilars through the approval of the highest number of biosimilars worldwide.3
The European Union, via the European Medicines Agency, issues specific guidelines to help developers conform to the regulatory requirements for biosimilars. The European Union’s guidelines evolve with scientific advances in biotechnology and take into account experience from clinical use.3 There is a centralised procedure established for biotechnology products and those for specific indications such as cancer. To date, the vast majority of approved biosimilars in Europe have been approved via this centralised procedure. Scientific review is undertaken by the European Medicines Agency while final marketing approval is issued by the European Commission. Each Member State then determines the criteria on interchangeability, substitutability and switching with the reference medicine.3