Legal win leads Amgen to at-risk launch of Eylea biosimilar
Closeup of vials on a conveyor at Amgen facility
Amgen has chalked up a victory in a patent infringement lawsuit with Regeneron over blockbuster ophthalmic drug Eylea and decided to launch its biosimilar in the US – even though the legal battle isn't yet over.
The bold decision puts Amgen at risk of hefty damages if future rounds in the litigation go Regeneron's way, offset by the rewards that could follow from the first launch of a lower-cost, copycat version of Eylea (aflibercept), which made sales of almost $5.9 billion in the US last year.
Amgen's move follows the lifting of a temporary injunction on the launch of its Pavblu-branded biosimilar by the US Court of Appeals for the Federal Circuit, which prompted the company to say it would launch "as quickly as possible to help expand access to affordable and effective treatment."
Regeneron retorted that "we continue to believe that Amgen is infringing our patent rights, and today's decision denying our request for a temporary injunction is not the final word in this litigation."
An appeal of a decision on the validity of the patents protecting Eylea in the US is still ongoing, and Regeneron will take some comfort from the court granting its request to accelerate the appeals process, with oral arguments scheduled to take place in January. It also plans to appeal the decision to remove the injunction on Pavblu's launch.
Eylea is FDA-approved to treat various sight-robbing diseases of the eye, including age-related macular degeneration, diabetic retinopathy, and diabetic macular oedema.
Pavblu is a copy of the original formulation of the anti-VEGF drug, and Regeneron recently launched a higher-dose version – called Eylea HD – which requires less frequent injections into the eye. In the second quarter of this year, overall sales of Eylea were just over $1.5 billion, with Eylea HD accounting for $304 million of that total.
The prospect of an Eylea biosimilar could have a knock-on effect on Roche's Vabysmo (faricimab), which also offers reduced dosing frequency and has been making inroads into the market at the expense of Regeneron's drug, pegging back its growth rate. Sales of Vabysmo were around $2.8 billion last year, $2.2 billion of which were booked in the US.
Regeneron has previously secured preliminary injunctions on the launch of two other Eylea biosimilars developed by Biocon and Biogen/Samsung Bioepis until after the expiry of its US patents on the drug, ostensibly in June 2027.
