Research & Manufacturing

Amgen is involved in all steps of the value chain

Developing biosimilars

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.

  Generics Biosimilars Biologics
Scientific Difficulty Low2   High2
Time Short   Long
(3-4 years)3 ~ 8 years3 (10+ years)4
Cost Low(<$5M)   High (<$1.2B)
Bioequivalence3 ~$200 M3 Full clinical development4
Manufacturing Process Simple, short4   Long, complex4

  2. Camacho LH, et al. Cancer Med. 2014;3:889-899.
  3. Federal Trade Commission. Emerging Health Care Issues: Follow-on Biologic Drug Competition. Published June 2009.
  4. Ventola CL. P T. 2013;38:270-87.

Clinical trials are designed with the most sensitive populations in mind

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
Biosimilar Study Status
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

  1. Last accessed November 2017.
  2. Cronstein B et al. Clinical Advances in hematology&oncology 2015. Last accessed November 2017.

Amgen is investing in efficient manufacturing

The manufacturing of both innovative biologics and biosimilars is a proprietary, multi-step process, tightly controlled and regulated to ensure clinical consistency1. Biosimilars 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.

  1. AL-Sabbagh et al. Seminars in Arthritis and Rheumatism 2016;45:S11-S18.
  2. Amgen, Clinical and scientific considerations for Biosimilars 2016.
  3. Cronstein B et al. Clinical Advances in hematology&oncology 2015. Last accessed November 2017.

Amgen is enforcing stringent quality controls

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

Biosimilars    Supply disruption may affect HCP decisions Biosimilars    ... and can directly impact patients
  • Rationing of therapies
  • Potential delays in initiating treatment
  • Switching to alternative products
  • Potential differences in immunogenicity and adverse events
  • Complications in traceability of adverse events
  • Prescription of unfamiliar therapies
  • Potential risk of administration errors
  • Increased case management and resources burden due to replacement or alternative stock management strategies
  • Increased health care costs
  • Potential delays in initiation/continuation of therapies
Amgen is committed to excellence in biotech manufacturing, implementing quality controls every step of the way. Over 250 quality checks are performed for each biosimilar, as well as continuous in-depth analysis in manufacturing performance in order to maintain consistency.6 In fact, biosimilars have strengthened our capabilities in biologics development and manufacturing via the processes we have developed and put in place for their development and manufacturing. As a result, Amgen is able to provide patients with treatment options even more reliably.

We have established a Quality Management System (QMS) across our supply chain to ensure the highest standards and batch-to-batch consistency. The QMS aims to:
  • Allow delivery of products with the necessary quality and functionality you’ve come to expect from Amgen
  • Establish and maintain a state of control for process performance and product quality
  • Facilitate continuous improvement
Thanks to our QMS we can monitor key performance and quality parameters and apply statistical control limits based on historical performance. In addition the QMS allows:
  • Product and process data trending with cross-functional review of product release testing data
  • Identification and response to trends during manufacturing
  • Continuous process verification
  • Annual product review
  • Evaluation of ongoing product stability

  1. Van Trieste. BioPharm International 2017;26:9
  2. Amgen, data on file
  3. Pauwels K et al. PLOS One 2016;10(3):e0119322
  4. Amgen, Clinical and scientific considerations for Biosimilars; 2016
  5. Mica A et al. GaBi Journal 2013:2:136-143

Supply reliability

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:

  • minimize risk of supply disruption
  • ensure that raw materials are always available
  • manufacture innovative biologics and biosimilars to the same high standards
  • provide our medicines to the patients that need them, when they need them
  • accurately forecast demand and adapt manufacturing accordingly to assure enough stocks are always on hand to meet demand
Due to our tight end-to-end control of the supply chain, we have a strong record of reliable drug supply with ~99% on-time and in-full deliveries over the last 5 years in Europe.1 Biosimilars
*On Time In Full (OTIF) is an industry standard to measure order delivery performance to our customers.
**Remaining ≈1% consist of returns & damaged products not resulting in interrupted supply or any patient impact

We continuously strive to sustain and improve our performance by applying an operational excellence mind set.

  1. Amgen, data on file

Adapting to the specific needs of biosimilars

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.

In order to ensure that our biosimilars reach every patient, every time, we have implemented additional processes to manage fluctuations in demand and production volumes. Moreover, Amgen will produce and retain sufficient safety stocks* of the final drug product to meet any sudden demand increases immediately. Smaller and more frequent lot productions ensure supply contingency and the required shelf life. Through close monitoring of demand, we will be able to respond immediately by manually adjusting production when and where needed to ensure continuous product availability.
* Safety stock: medicine that is manufactured in excess of demand and maintained in storage to cover any unpredicted spikes in demand

  1. IMS, Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape. 2011.

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