Drugmaker AbbVie Inc. has filed a patent-infringement lawsuit against rival Amgen Inc. seeking to halt looming sales of a lower-priced replica of AbbVie’s top-selling drug, Humira.
The lawsuit, filed late Thursday in federal court in Delaware, alleges Amgen’s copy of Humira violates many of AbbVie’s patents on the anti-inflammatory treatment. The suit asks the court to block any sales.
Humira accounts for about 60% of AbbVie’s revenue. AbbVie has been taking steps, including filing new patents protecting Humira, to delay the introduction of copies, and has told analysts it expects copies to hit the market no earlier than 2022.
AbbVie’s legal challenge was an expected step, which was authorized under the federal law that aimed to bring price competition to expensive biotech drugs. Copies of these drugs are known as biosimilars.
The law, the Biosimilar Price Competition and Innovation Act, established a mechanism for companies to secure approval of biotech drug copies without doing all the testing a new medicine would require.
In its lawsuit, AbbVie said the law “does not give Amgen license to infringe AbbVie’s patents.” AbbVie also threatened further patent infringement suits because it claims 61 Humira patents are being infringed.
Humira is one of the top-selling drugs in the U.S., with $8.4 billion in sales last year. It is also expensive, with a list price of $53,260 a year.
Biosimilars were authorized as part of the 2009 federal health-care overhaul to reduce spending on such biotech drugs, much like generics have cut the costs of pills.
Given Humira’s success, several drug companies have been developing biosimilar versions. Amgen already sells a brand-name rival, Enbrel.
The Food and Drug Administration hasn’t approved Amgen’s biosimilar Humira yet, but the decision is nearing. Last month, a panel of outside experts recommended approval.
Amgen said Friday it doesn’t comment on litigation, but that it is working with the FDA as the agency completes its review of the company’s biosimilar Humira.
The patent-infringement challenge is likely to delay launch of Amgen’s biosimilar, if it is approved, until the legal issues are resolved. Launch could be delayed even further if AbbVie decides to file another infringement lawsuit involving additional patents, after an FDA decision on approving the biosimilar.
A litigation delay followed the approval last year of the first biosimilar, Novartis AG’s Zarxio, which was a replica of an Amgen cancer-care drug called Neupogen.
As a result, Zarxio, which was approved in March 2015, didn’t go on sale until September. Novartis sold its drug at a 15% discount to the original.
This week, CVS Health Corp., whose Caremark unit administers drug benefits for many employers and insurers, took steps to start steering patients to biosimilars.