Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of Genentech’s motions to enjoin sales of MVASI in the United States. MVASI is an FDA-approved biosimilar of Genentech’s…
We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture. As we reported…
The U.S. District Court for the District of Delaware has denied Amgen’s motion to consolidate a recently filed action against Pfizer and its affiliate Hospira relating to Hospira’s filgrastim biosimilar with an ongoing litigation between the parties involving the same product, which is set for trial in May 2021. As…
On June 28, 2020, Genentech filed a complaint against Samsung Bioepis (Bioepis) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Bioepis’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). As relief, Genentech’s complaint requests a court declaration that the…
Researchers from the University of Arizona Cancer Center recently presented results of a simulation designed to model the cost savings from converting patients from pegfilgrastim to biosimilar pegfilgrastim-cbqv. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 29-31, 2020. The researchers conducted simulation…
Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved an investigation new drug (IND) application[1] of HLX14, a denosumab biosimilar. Denosumab is a recombinant humanized anti-RANKL monoclonal antibody for injection that is approved for the treatment of postmenopausal women with osteoporosis with a high…
On June 16, 2020, Shanghai Henlius Biotech, Inc. announced that HLX04-mCRC03, a phase 3 clinical trial of bevacizumab biosimilar HLX04, had successfully met its primary endpoint. The study compared the safety, efficacy and immunogenicity of HLX04 and Avastin in combination with oxaliplatin and fluoropyrimidine-based chemotherapy as first-line treatment in patients…
Today, the Supreme Court denied three petitions for certiorari challenging the constitutionality of subjecting patents issued prior to the America Invents Act (“AIA”) to inter partes review (“IPR”). See Celgene v. Peter; Collabo v. Sony Corp.; Enzo v. Becton, Dickinson and Company. In all three underlying cases, the U.S. Court of Appeals for the Federal Circuit had…
This week, the FDA approved LYUMJEV (insulin lispro-aabc), a new insulin lispro product by Lilly. LYUMJEV is a formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. Lilly’s insulin lispro product HUMALOG was originally approved in 1996. The corresponding Lilly…
Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration. Semglee’s amino acid sequence is identical to that of Sanofi’s Lantus, and Biocon’s CEO and Managing Director, Dr. Christiane…