In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron.  Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with a vascular endothelial growth factor

In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation.  The Court’s ruling on the permanent injunction follows a nine-day bench trial, held in June 2023, after which the Court held on December 27, 2023 that YESAFILI (Mylan/Biocon’s

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)

On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345).  The vaccine was designed to protect adults from lower respiratory tract disease caused by an RSV infection.  This is the second mRNA vaccine Moderna has developed to gain FDA approval, following approval of Moderna’s COVID-19 vaccine.

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab.
On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars.  According to Sandoz, these two drug products are the

On May 20, 2024, Teva Pharmaceuticals (“Teva”) and Alvotech announced the availability of SIMLANDI (adalimumab-ryvk) injection in the United States, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.  As we previously reported,

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program.  The START program, led by the Center for Biologics Evaluation and Research (“CBER”) and Center for Drug Evaluation and Research (“CDER”), was designed to “help further accelerate the development of novel drug and biological

On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar.  Denosumab, sold by Amgen under the brand names PROLIA and XGEVA, is indicated for the treatment of various diseases including osteoporosis in postmenopausal women and prevention