Biotech leader

Amgen is a global leader in biotechnology since 1980

Amgen is an expert in the development of biologic medicines

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.

timeline 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.

What are biologics?

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.

Small Molecule Biologics
Acetylsalicylic acid
~180 daltons
Insulin
~5,700 daltons
Growth hormone
191 amino acids
~22,000 daltons
Monoclonal antibodies (mAb)
~1,300 amino acids
~150,000 daltons
Generic Small Biologic Large Biologic
Same Structure Highly Similar Structure

  1. Prugnaud JL. Br J Clin Pharmacol. 2007:619-620.

Biosimilars are viable as treatment options

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
Biopharmaceuticals Traditional 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

  1. EMA, Overview biosimilars medicines http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp&mid=WC0b01ac0580bb8fda. Accessed June 1 2017
  2. Heinrichs M, et al. Am Health Drug Benefits 2008;1(5): 21-26

The value of biosimilars

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

  1. The Pharma Letter. https://www.thepharmaletter.com/article/biosimilars-can-help-answer-the-cost-questions-that-are-underpinning-asco-discussions. Last accessed November 2017
  2. Tabernero J et al. ESMOOpen 2016;1:e000142
  3. WHO. http://www.who.int/about/agenda/en/. Last accessed November 2017

European experience with biosimilars

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

  1. Zelenetz AD, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw. 2011;9 Suppl 4:S1-S22
  2. Biosimilars approved in Europe. GaBI online. March 31,2017. Available at: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed April 20, 2017
  3. EMA, Biosimilars in the EU: Information guide for Healthcare Professionals. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf

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