Ms Reed believes that there are lessons to be learned from the generics market. More than 30 years ago, in September 1984, the ‘landmark’ Drug Price Competition & Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, was signed into US law [2]. Following its implementation, the generics share of the pharmaceutical market grew steadily and substantially. This has resulted in generics accounting for about 90% of the four billion prescriptions written in the US each year, while only accounting for about 22% of overall drug spending. Pre-Hatch-Waxman generics made up only 18% of prescriptions.

In fact, 95.3% of generics prescriptions are filled at US$20 or less. The US healthcare system has saved US$2 trillion in the last decade due to patient’s accessing low-cost generics, US$293 billion of which came in 2018 alone.

According to Ms Reed, in order to obtain a sustainable and competitive biosimilars market the following criteria need to be met:
• Fair and early access to the market
• Appropriate pricing
• Biosimilars from several competitors on the market
• Broad insurance coverage
• Educated and supportive physicians and patients

In order to support the viability of biosimilars anti-competitive behaviours that disincentivize biosimilars uptake need to be addressed. In addition, Institute proactive policies that incentivize biosimilar uptake need to be introduced.

Some measures have already been put in place to address anti-competitive behaviours, including:
• Trump administration signed a bill requiring drug makers to send details of biosimilar deals to the Federal Trade Commission (FTC) for scrutiny.
• Senators Grassley and Klobuchar wrote to FTC Chairman Simons urging the FTC to help end anti-competitive behaviours that hinder or delay market entry of biosimilars [3].
• FDA’s Biosimilar Action Plan states that FDA will coordinate with the FTC to address anticompetitive behaviour [4].

Institute proactive policies that incentivize biosimilar uptake, include:
• Reducing out-of-pocket patient costs – This could save up to US$5.2 billion in taxpayer dollars over the next 10 years.
• Shared savings with prescribers – This could save up to US$3 billion in taxpayer dollars over the next 10 years.
• Increase ASP*-add-on payment rate – This could save up to US$8.2 billion in taxpayer dollars over the next 10 years

Ms Reed believes that these solutions ‘would have an immediate impact to help patients and providers share savings associated with biosimilars and reduce costs to the Medicare program’.

*ASP is a market-based price that reflects the weighted average of all manufacturer sales prices and includes all rebates and discounts that are privately negotiated between manufacturers and purchasers (with the exception of Medicaid and certain federal discounts and rebates).

Related article
The sluggish US biosimilars market

References
1. Reed J. The State of the Biosimilars Market. DIA Biosimilars Conference; Bethesda, Maryland, US; 23-24 September 2019.
2. GaBI Online - Generics and Biosimilars Initiative. Thirty years of generics in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Generics/General/Thirty-years-of-generics-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Pay-for-delay bill reintroduced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Policies-Legislation/Pay-for-delay-bill-reintroduced
4. GaBI Online - Generics and Biosimilars Initiative. FDA releases guidances and proposed rule to advance biosimilars policy framework [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Guidelines/FDA-releases-guidances-and-proposed-rule-to-advance-biosimilars-policy-framework

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