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Key Issues

Fostering sustainable biosimilars markets

In this report we have suggested a number of key reforms or areas for discussions and development that will help to ensure competitive markets for biosimilars in Europe and the U.S.

If addressed, these key areas would help ensure significant savings for healthcare providers and payers, while also offering pharmaceutical companies sufficient return on investment to incentivise new drug and biosimilar development.

The key issues are:

  1. Strong IP protection for originator biologics to encourage innovations, alongside effective incentives for competition once patents expire. The cost of development is so high for new biological drugs that originators need a sufficient period to recoup their costs and fund further new drug development.

  2. Policies and actions by payers to encourage the uptake of biosimilars. Positive action by payers – whether state or private – may be required to rapidly create competitive biosimilar markets. There is clear evidence that measures taken by payers are necessary to create demand for, and acceptance of, biosimilars.

  3. Elimination of single-winner tenders. Multiple-winner tenders are felt by most expert commentators to create healthy levels of competition over time, by keeping several champion-challenger players in each biologics category.

  4. A harmonised understanding of what constitutes sustainable market discounting would benefit all stakeholders. As the next wave of biosimilars are approved, it is critical that obstacles to market access and rock bottom prices are avoided, otherwise there are real fears that there will be no further investment in future biosimilar development.   The more mature open markets Europe provide data for the debate around discounts/savings that avoid discouraging market development through unsustainable price erosion.

  5. Increased clinical and payer communications and education from official bodies about (a) available biosimilars and (b) their quality and efficacy. Payers and patients are still insufficiently aware of the range of biosimilar alternatives and their clinical outcome and safety equivalency to original biologics. Where the state, or official bodies, promote biosimilars, take-up improves significantly.

  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. The resulting cost-savings can then be shared with providers and payers through competitive pricing which does not undermine future product development investment capabilities.

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