AstraZeneca Accused of Stifling Biosimilar Competition for Rare Disease Drug

AstraZeneca’s rare disease division, Alexion Pharmaceuticals, has been hit with a proposed class action lawsuit in federal court, accusing the company of unlawfully extending its monopoly on the high-cost blood-disorder drug Soliris through improper patent practices.

According to Reuters, the complaint, filed Wednesday in the U.S. District Court for the District of Massachusetts by New York-based health insurer EmblemHealth, claims Alexion manipulated the U.S. patent system to delay competition from lower-cost biosimilars. The lawsuit alleges that after Soliris’ original patents were set to expire in 2021, Alexion obtained additional patents under questionable circumstances, effectively prolonging its market exclusivity until at least March 2025.

Per Reuters, the health plan asserts that this maneuver violates U.S. antitrust laws and has already led to significant financial consequences. EmblemHealth estimates that the delayed entry of biosimilars could result in over $2 billion in excessive spending on the medication, which is used to treat rare blood disorders such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

EmblemHealth is seeking to represent a nationwide class of Soliris purchasers in the case. It argues that AstraZeneca’s actions amounted to a “scheme” to artificially maintain a monopoly on one of the most expensive prescription drugs in the country. According to the complaint, Soliris can cost as much as $500,000 per patient annually and ranks among the highest-priced drugs in U.S. history.

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“We are concerned about practices that shut down competition and increase drug costs. That’s what this litigation is about,” an EmblemHealth spokesperson stated.

AstraZeneca, which acquired Alexion in 2021, declined to comment on the pending litigation when contacted by Reuters.

The lawsuit further alleges that AstraZeneca misled the U.S. Patent and Trademark Office to secure patents with expiration dates that stretch “well into the future.” These patents were then allegedly used to strike settlement agreements with rival drugmakers, preventing the market entry of competing biosimilar drugs.

Soliris remains a major revenue driver for AstraZeneca, generating over $1.4 billion in sales in the first half of 2024 alone, according to company reports cited by Reuters.

EmblemHealth is represented by attorneys Thomas Sobol and Gregory Arnold of Hagens Berman Sobol Shapiro, as well as Mark Fischer and Rob Griffith of Rawlings & Associates.

The case is EmblemHealth Inc v. Alexion Pharmaceuticals Inc, U.S. District Court for the District of Massachusetts, No. 1:25-cv-10985.

Source: Reuters