Photo of a judge’s gavel, a balance and a stack of papers
iStock,
lakshmiprasad S
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
Regeneron Pharmaceuticals
this week
filed a lawsuit
against
Sandoz
claiming that the generics giant’s recently approved biosimilar to Eylea (aflibercept) infringes on the pharma’s patent protections.
In its legal complaint, filed in the District Court for New Jersey, Regeneron cites the Biologics Price Competition and Innovation Act (BPCIA), which speeds up the regulatory process for biosimilars. Under the BPCIA, biosimilar developers are required to provide specific information relevant to the proposed copycat and the reference branded product.
This disclosure should be made within 20 days after the FDA accepts the biosimilar application for review, according to Regeneron’s lawsuit.
However, the pharma alleges that Sandoz did not turn over the BPCIA-required information, even after the biosimilar had cleared regulatory review. “It is abundantly clear that well over 20 days have elapsed the FDA’s acceptance” of the abbreviated Biologics License Application (aBLA), “yet Sandoz still has not provided the information to Regeneron,” according to the lawsuit.
“Sandoz’s failure to provide this information is a violation of the BPCIA that authorizes Regeneron to bring claims for patent infringement against Sandoz,” the pharma claimed. Regeneron is asking a judge to prevent Sandoz from marketing its biosimilar and for monetary relief.
The drug at the center of this legal battle is
Eylea
, a blockbuster anti-VEGF recombinant fusion protein indicated for neovascular age-related macular degeneration (AMD), retinal vein occlusion, diabetic retinopathy and other eye diseases. Eylea works by acting as a decoy receptor against both the VEGF-A and PIGF ligands, disrupting their downstream cascades and preventing the growth of abnormal blood vessels in the eye.
Since its
first approval in 2011
for neovascular AMD, Eylea has become one of Regeneron’s top assets. Last year, the blockbuster eye injection
brought in over $5.7 billion
, a 9% dip from 2022. According to the pharma, the slowdown in Eylea sales is due to “changing market dynamics, resulting in a lower net selling price and lower volumes.”
The entry of biosimilar competitors has contributed to the declining sales of Eylea. In May 2024, the FDA
approved two copycats
—Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy). Both biosimilars also have the interchangeability designation, allowing their use instead of Eylea without needing to change the prescription.
Earlier this month, the FDA
signed off
on Sandoz’s own biosimilar, dubbed Enzeevu (aflibercept-abzv). Like Yesafili and Opuvis, Enzeevu is also interchangeable with Eylea, though the designation is still provisional “subject to an unexpired exclusivity for the first interchangeable biosimilar products,” according to the company.
