Regeneron sues Amgen over biosimilar version of blockbuster eye drug
US biotech has launched multiple suits over alleged infringement of Eylea patents | Regeneron asks US court to block Amgen’s biosimilar before potential approval.
Regeneron has continued its bid to fend off proposed biosimilars to its blockbuster eye drug with a lawsuit against Amgen in response to the California-based biotech’s proposed copy of Eylea.
In its complaint filed last week (January 10) at the US District Court for the Central District of California, Regeneron accused Amgen of infringing over 30 patents related to Eylea, a treatment for several serious eye diseases.
Eylea comprises a genetically engineered protein called aflibercept, and works by blocking the overproduction of a naturally occurring protein in the eye that can cause the formation of new blood vessels and lead to vision loss.
In October last year, Amgen announced that the US Food and Drug Administration (FDA) had accepted its abbreviated Biologics Drug Application (aBLA) for a biosimilar copy of Eylea, called ABP 938.
Regeneron is seeking to block Amgen’s biosimilar, which it says infringes its patents and may be approved as soon as Eylea’s regulatory exclusivity expires in May this year.
The complaint stated Regeneron was filing the action “to obtain relief before Amgen launches ABP 938 in the United States”.
Amgen had failed to provide “the factual and legal basis for its opinion” that Regeneron’s patents were invalid or would not be infringed, according to the court filing.
Multiple suits
Regeneron earned $6.26 billion in US sales from Eylea in 2022, Reuters reported. The drug is covered by a multitude of patents that cite “biological products” or “methods of making biological products”.
Earlier this month, the New York-headquartered biotech convinced a West Virginia district court that Mylan—now part of Viatris— had infringed an Eylea patent, US number 11,084,865.
However, Mylan persuaded the court that two other Regeneron patents asserted in the suit—US numbers 11,253,572 and 10,888,601—were invalid due to obviousness.
All three patents are listed in Regeneron’s latest suit against Amgen.
On the same day as the ruling in West Virginia, Regeneron filed a complaint against Samsung Bioepis, alleging infringement of 51 patents related to Eylea.
In the case against Amgen, Regeneron is represented by BKLW and Williams & Connolly.
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