Life Effects
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Management summary

Biological drugs have transformed the modern medicine over the last three decades, in many cases offering effective therapies for previously untreatable conditions.

But reaping wider benefits – particularly for patients and healthcare systems - depends on grasping the huge potential in a small, but growing area of the biopharmaceutical market: biosimilars.

These drugs are highly similar copies of original biologics that are no longer protected by patents. While being very difficult to create, biosimilars still offer substantial savings that could make them much more widely available to patients than their original equivalents.

We are entering a key period in realising biosimilars’ potential. Between 2018 and 2023, a large number of original biologic drugs will come off patent. This offers the tantalising opportunity for the next wave of biosimilars   2019 and onwards.

One key academic study has predicted that, in the U.S. alone, $54 billion will be saved as a result of competitive biosimilars markets.

Over time, it is expected that biologics and biosimilars will deliver a net benefit to healthcare systems, reducing lifetime healthcare consumption and improving healthcare systems efficiency.

But, for now, biological drugs are expensive to develop and costly for healthcare systems to use, despite their immediate and long-term patient benefits. This is why building a competitive biosimilar markets is so important.

Such competitive markets typically deliver significant pricing discounts to healthcare providers on biologics/biosimilars. But, while sustainable competitive markets in biosimilars have to offer competitive discounts, they must also remain sufficiently attractive to pharmaceutical companies, so the latter continue to consider investing in new product and biosimilar pipelines worth the high level of risk.

In this report we look at the scale of the prize on offer, and highlight the key issues that payers, providers, regulators and the pharmaceutical industry need to address together to create sustainable competitive markets in biosimilars.


To rapidly and effectively establish sustainable biosimilars markets in Europe and the U.S. the following issues need to be addressed:

  1. Strong IP protection for originator biologics to encourage innovations, alongside effective incentives for competition once patents expire.
  2. Policies and actions by payers to encourage the uptake of biosimilars.
  3. Elimination of single-winner tenders.
  4. A harmonised understanding of what constitutes sustainable market discounting would benefit all stakeholders.
  5. Increased clinical and payer communications and education from official bodies about (a) available biosimilars and (b) their quality and efficacy.
  6. Increased adoption of new-generation, Industry 4.0 technology in the pharmaceutical industry, in order to improve efficiency, quality and agility, both in manufacturing and discovery/development.