Big Molecule Watch
June 8, 2024

Updates on Aflibercept Biosimilar Approvals and BPCIA Litigation

FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions

Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024.  Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI (aflibercept-jbvf) and Samsung Bioepis, Co., Ltd.’s OPUVIZ (aflibercept-yszy) as interchangeable biosimilars to Regeneron Pharmaceutical, Inc.’s EYLEA (aflibercept).  These are the first biosimilar aflibercept products approved by the FDA.

According to the announcement, YESAFILI and OPUVIZ are used to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.  Both YESAFILI and OPUVIZ are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the aforementioned conditions according to dosing regimens as recommended in the product labeling.

Court enters order extending Temporary Restraining Order

As we previously reported, the Judicial Panel on Multidistrict Litigation granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation.  Pursuant to that order, Regeneron’s BPCIA case against Amgen, Inc. (“Amgen”) was transferred from the Central District of California to the Northern District of West Virginia (“N.D.W.V.”) and consolidated for pretrial proceedings with Regeneron’s actions pending there against Mylan/Biocon, Celltrion, Formycon, and Samsung Bioepis, with Chief Judge Thomas S. Kleeh presiding.

Judge Kleeh held an initial scheduling conference in the MDL on May 17, 2024, one day before Regeneron’s FDA exclusivity for EYLEA was set to expire.  As we previously reported, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.”  On May 17, 2024, the Court granted Regeneron’s motion for a TRO against Mylan and Samsung Bioepis, and entered a sealed order as to Formycon, and a sealed stipulation as to Celltrion, regarding the original TRO.

Regeneron filed a motion to extend the TRO, stating, “[a]t the Court’s direction . . . Regeneron has since submitted a proposed order to accompany its permanent injunction motion.  Cognizant of the length of that submission—and that of Defendants’ simultaneous submission, and those filed in the other cases in this multi-district litigation—Regeneron seeks to extend the TRO an additional fourteen days, in the event that it is not feasible for the Court to adjudicate the permanent injunction motion before May 31, 2024.”  On May 30, 2024, the Court issued an order extending the TRO 14 days beyond its original expiration, to June 14, 2024.   The Court stated in the order that there is “good cause to extend the Temporary Restraining Order, so that the status quo is preserved until the adjudication of the permanent injunction motion.”

Regeneron narrows preliminary injunction patents to one patent

On May 21, 2024, Regeneron filed a motion withdrawing its pending preliminary injunction motions against Celltrion, Formycon, and Samsung Bioepis on all patents other than U.S. Patent No. 11,084,865 (“the ’865 patent”).  Regeneron stated in its motion that “[i]n an effort to streamline the issues in dispute in the Preliminary Injunction motions, Regeneron moves to withdraw its Motions for Preliminary Injunction with respect to patents other than U.S. Patent No. 11,084,865.  As a result, Regeneron’s Motions for Preliminary Injunction now seek the same relief as to all Defendants—a preliminary injunction in connection with infringement of U.S. Patent No. 11,084,865.”

On May 24, 2024, Amgen filed an emergency motion to clarify whether Regeneron’s preliminary injunction motion against Amgen would also be limited to the ’865 patent.  On May 28, 2024, the Court granted Regeneron’s motion withdrawing portions of its preliminary injunction motions that do not relate to the ’865 patent and clarified that “any preliminary injunction motion filed against Amgen shall also be limited to the ’865 patent.”

Court provides amended preliminary injunction briefing schedule in Amgen case

The Court issued an amended preliminary injunction briefing schedule with respect to Amgen on May 28, 2024.  Regeneron’s Motion is due on or before June 7, 2024; Amgen’s Response is due on or before June 21, 2024; and Regeneron’s Reply is due on or before July 3, 2024.


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