Failure to launch? Mixed views on US biosimilar market

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/C5Media)
(Image: Getty/C5Media)

Related tags: Biosimilars, Us, European union

Differing reports on the impact of biosimilars in the US paint an unclear picture of what to expect in 2020.

Much was expected of biosimilars and their potential to cut the price of originator biologics, with savings projected​ to reach hundreds of billions of dollars.

Such expectations, at least in the US, have proven, so far, to be unrealistic. A report produced last year outlined that the US healthcare system is failing to make savings worth $7.2bn (€6.5bn) annually​.

As we begin 2020, researchers have begun picking apart the adoption of the biosimilars in the US to determine how successful their introduction onto the market could be deemed to be. The results varied.

The faltering story so far

In one report​ by Jinoos Yazdany, chief of the division of rheumatology at the Zuckerberg San Francisco General Hospital, pointed towards the inability of infliximab biosimilars to successfully gain a foothold on the market as representative of the wider problem of uptake.

Yazdany stated that infliximab biosimilars made up less than 1% of anti-TNFi sales for a commercial payer covering 14 million US citizens. In addition, she outlined that of the 13 biosimilars approved for rheumatic diseases, only two have reached the commercial market.

As a result, Yazdany concludes, “In other words, biosimilars have largely failed to launch in the US.”

As for the reasons why there has been such a limited penetration of the market by biosimilars, Yazdany highlights four areas that create barriers to uptake, broadly grouped into legal, financial, regulatory and clinical.

A contradiction?

In Yazdany’s analysis, the European Union’s approach has been the more successful, as she notes that “sales in Europe continue to rapidly expand and robust cost savings have materialized.”

The US is often used as a contrast to this, with the uptake of Humira (adalimumab) biosimilars​ last year easy to compare to the failure for such biosimilars in the US​ to gain similar market access, with introduction of US biosimilars expected in 2023.

However, a recent report​ published on the Jama Network Open used filgrastim, pegfilgrastim, infliximab, and insulin glargine as case studies to determine how far biosimilar entry to these medicines had resulted in savings.

On all four medicines, the researchers noted that “the net prices of originator biologics decreased following the entry of biosimilars or other substitutes,”​ with this decrease beginning two to three years prior to the introduction of competitors, in the cases of infliximab and insulin glargine.

The report noted that post-introduction of competitors, the net price of filgrastim, pegfilgrastim, infliximab, and insulin glargine fell by an annual average of 7.7%, 7.5%, 13.6% and 14.4%, respectively.

Industry expects biosimilar impact in 2020

This latter analysis suggests that the impact of biosimilars in the US is gathering pace, at least on the impact of the net price of the originator product and therefore not reflected in overall sales of biosimilar products.

However, a report by GlobalData​ suggests that the biosimilar market will gain a ‘strong foothold’ during 2020, which collated the expectations of industry representatives regarding the areas likely to affect the US pharma industry.

The report cited the introduction of Amgen’s Avastin (bevacizumab) and Herception (trastuzumab) biosimilars as two successful launches during 2019, which saw uptake by insurers, such as United Healthcare, as a good indication for future biosimilars.

Bonnie Bain, global head of pharma at GlobalData, stated, “Even though the price differential between biosimilars and their branded counterparts is only around 15-30%, which is significantly less than the cost savings seen with the average generic drug, we still expect that biosimilars will start to contribute cost-savings in the US in 2020.”

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