On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ’099 patent issued on the same day, with claims generally directed to a stable liquid ophthalmic formulation with a vascular endothelial growth
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Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent
By Grace Truong
Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”) of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”). The ’865 patent issued on August 10, 2021 and is generally directed to an ophthalmic…
Biosimilar Manufacturers to Expand Offerings in Europe and Japan
On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe.
Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan. One of these candidates is SB17, a biosimilar of Janssen’s STELARA (ustekinumab). Under the agreement,…
Senate Banking Committee Proposes Bill That Would Eliminate CFPB Federal Reserve Funding
In June 2025, the Senate Banking Committee introduced a version of the “One Big, Beautiful Bill” that would eliminate the CFPB’s Federal Reserve funding.
The CFPB can currently receive funds of up to 12% of the Federal Reserve’s 2009 profits. The House Financial Services Committee already introduced a version of the bill that would…
Third Circuit Holds That Granting Discovery Under Section 1782 Is Not a “Final” Judgment
The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the decision is not “final” and thus may not be appealed under 28 U.S.C. § 1291. The…
Acting Comptroller of the Currency Discusses OCC’s Regulatory Agenda
By Robin Muir
In recent remarks delivered at the U.S. Chamber of Commerce Capital Markets Summit, Acting Comptroller of the Currency, Rodney E. Hood, outlined the OCC’s strategic priorities for building a resilient and revitalized federal banking system. Addressing an audience that included leaders from across the financial and business sectors, Acting Comptroller Hood emphasized the importance of…
The SEC Solicits Public Comment on the Definition of Foreign Private Issuer
Today, the SEC issued a concept release to solicit public comment on the definition of foreign private issuer (“FPI”). It has been many years since the SEC last considered what it means to qualify as a FPI. While it is too early to predict how the SEC might ultimately revise the definition, the data and…
Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe
On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.” PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over…
Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions like unresectable giant cell tumors. Earlier this year, Samsung also received approval in Korea for…
EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars
By Sam Herron
On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates.
The applications for the two candidates, biosimilars to Amgen’s PROLIA (denosumab) and XGEVA (denosumab), respectively, cover “all indications covered by the reference products for treating different…