Amgen is a leader in biotechnology and has helped develop the processes through which biological medicines are made.
With state-of-the-art research and manufacturing facilities and stringent quality control processes, Amgen is involved in all steps of the value chain to ensure that patients are treated with high quality medicines.
The development of biosimilars is long and costly in comparison to generics. Generic medicines are not required to undergo clinical testing. It is sufficient to demonstrate that the product has the same quantitative and qualitative composition as the originator and that it is equivalent. Biosimilars, however, must undergo comprehensive comparability testing including the generation of clinical data.
Moreover, manufacturing, of biosimilars is complex, as with all innovative biologics.
|(3-4 years)3||~ 8 years3||(10+ years)4|
|Bioequivalence3||~$200 M3||Full clinical development4|
|Manufacturing Process||Simple, short4||Long, complex4|
Unlike generics, biosimilars must undergo Phase III clinical trials. These are conducted in sensitive patient populations, using sensitive endpoints to detect any differences with the reference product. Any differences should be demonstrated as not clinically significant.
Clinical development of the biosimilar begins with studies to demonstrate comparable pharmacodynamics and pharmacokinetics with the reference product. Biosimilar manufacturers must demonstrate that their molecule has similar characteristics, efficacy and safety as the originator. Studies to demonstrate the safety (including immunogenicity studies) are part of this characterisation. This data is then supplemented by a Phase III clinical comparability trial to confirm similar safety and efficacy of the biosimilar.
Clinical trials for biosimilars should use sensitive end points, rather than duplicating the clinical trials of the originators. For oncology biosimilars, pathologic complete response and overall response rates are the preferred end points to demonstrate biosimilarity.1 The dosing of biosimilars is also important, especially for agents that are administered chronically. Dosages should remain consistent between biosimilars and originators to avoid confusion.2
Amgen’s clinical development program is designed to generate robust and rigorous data, in the most sensitive patient populations, with the most sensitive end points for biosimilarity. Therefore healthcare professionals and patients can feel confident in choosing Amgen biosimilars.
|Amgen clinical trial programme¹|
|ABP 980||HER2+ early breast cancer||completed|
|ABP 215||Advanced NSCLC||completed|
|ABP 798||Non-Hodgkin lymphoma||recruiting|
|Moderate to severe rheumatoid arthritis||recruiting|
|ABP 710||Moderate to severe rheumatoid arthritis||recruiting|
|ABP 510||Moderate to severe plaque psoriasis||completed|
|Moderate to severe rheumatoid arthritis||completed|
|Moderate to severe rheumatoid arthritis (long term)||completed|
The manufacturing of both innovative biologics and biosimilars is a proprietary, multi-step process, tightly controlled and regulated to ensure clinical consistency1.
Complex biologics, such as monoclonal antibodies, are sensitive to manufacturing conditions.2 Manufacturing processes, such as methods to purify the cell line, and the raw materials used, can affect post-translational modifications – even if the protein sequence is the same as the originator. This can impact important attributes, such as the mechanism of action, bioavailability, immunogenicity or target binding.2 The manufacturing process is one of the key challenges in the development of biosimilars and biologics as any alterations can also introduce batch-to-batch variations.3
At Amgen, our biosimilars are held to the same high standards as our innovative biologics. We use the same network of scientists and the same state-of-the-art manufacturing facilities for all our products to ensure high quality manufacturing, reliable supply and batch-to-batch consistency for all our treatments.
Issues with quality are the most common reason manufacturers halt or slow down production, and this can seriously impact patients’ health and as such are a public health issue that needs to be addressed.1, 3,4 Shortages of prescription medicines is a growing problem around the world and can have a significant impact.5
|Supply disruption may affect HCP decisions||... and can directly impact patients|
The reliable supply of medicines to patients is important to us. Based on our 40 years of experience as a pioneer in innovative biologics, we have put in place the processes and control systems necessary to eliminate the risk of interrupted supply. At Amgen, we control our entire supply chain which allows us to:
Higher patient access and adoption rates mean that the demand patterns for biosimilars differ from those of innovators.1 This can present additional challenges in manufacturing and logistics.