US Biosimilar Launches, Stymied by Manufacturer Opposition, Continue to Struggle, Analysis Finds

Biosimilar launches in the United States continue to follow a low trajectory and have produced just slim price reductions, despite optimistic projections for acceptance and savings a decade ago, according to a journal report by Jinoos Yazdany, MD, MPH, of the Division of Rheumatology of Zuckerberg San Francisco General Hospital at the University of California, San Francisco.

Between 2016 and 2019, the 2 available biosimilars for infliximab (Remicade) made up less than 1% of anti-TNFi sales for a large commercial payer with a covered patient population of 14 million Americans, according to the report, published in Arthritis & Rheumatology.¹ Just 2 of 13 biosimilars with indications for rheumatic diseases approved by the FDA have reached the commercial market. “In other words, biosimilars have largely failed to launch in the United States,” Yazdany wrote.

The disappointing market development for biosimilars in the United States is in stark contrast to market growth in Europe, where single-payer systems in Denmark and Sweden have eased the path for complex biologics. Denmark realized a two-thirds cost savings through its competitive bidding process completed with mandatory switching, Yazdany noted.²

In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.³

Yazdany noted that a major roadblock to biosimilar acceptance is the barrage of patent protections and other legal actions that originator drug manufacturers throw up to protect markets for their products. She called these tactics “unprecedented in scale.”

Companies have successfully extended the 12-year exclusivity period for originator biologics created by the Biologics and Price Competition and Innovation Act by filing lawsuits and numerous patents that significantly complicate the pathway to approval for biosimilars.

For example, Yazdany said, AbbVie has filed over 200 patents and patent applications for adalimumab (Humira) that cover manufacturing methods, the drug itself, and ancillary aspects related to drug use. This total is more than 3 times the number of patents filed in the European Union (76) or in Japan (63) for the same drug.⁴

“Accusations that AbbVie is systematically attempting to delay market entry of its competitors are supported by the fact that nearly half of its patent applications in the US were filed after the patent expiration date in 2014,” Yazdany said. A recent settlement with Boehringer Ingelheim achieved by the manufacturer successfully delayed the launch of the biosimilar adalimumab-atto, approved in 2016, until 2023. “During this time, Humira’s price has increased 18% each year, rising from $16,000 to over $30,000 from 2012 to 2016 alone.”

Yazdany noted that these price increases get passed on to payers, including Medicare, and patients, thereby broadening the circle of losers in these product exclusivity battles.

A potential solution to the patent “thicket” is the Biologic Patent Transparency Act, a bipartisan piece of legislation that would require biologic manufacturers to disclose and publish patents in the Purple Book, a publicly searchable database. The act would limit the enforcement of patents that are filed after a biosimilar application has been submitted to the FDA.

“The fate of this legislation is unclear, and its potential impact on reducing the patent thicket remains to be seen,” Yazdany wrote.

References

1. Yazdany J, Failure to launch: biosimilar sales continue to fall flat in the United States [published online January 10, 2020]. Arthritis Rheumatol. 2020; doi:10.1002/art.41203.
2. Jensen TB Bartels D, Sædder EA, et al [published online November 1, 2019]. Eur J Clin Pharmacol. doi: 10.1007/s00228-019-02765-3.
3. Woollett G, Jackson J. Use of step-through policies for competitive biologics among commercial US insurers. Avalere Health website. avalere.com/insights/use-of-step-through-policies-for-competitive-biologics-among-commercial-us-insurers. Published May 2018. Accessed December 8, 2019.
4. Price WN, Rai AK. How logically impossible patents block biosimilars. Nat Biotechnol 2019;37(8):862—863. doi: 10.1038/s41587-019-0196-x.