Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients aged 12 years and older with eosinophilic esophagitis (EoE). EoE is a chronic, immune-mediated, atopic inflammatory condition of…
It has been reported that U.S. pharmacy benefit manager CVS will drop Sanofi’s insulin drugs, Lantus® (insulin glargine injection, 100 units/ml) and Toujeo® (insulin glargine injection, 300 units/ml) from the list of medications for which it reimburses on behalf of health insurers. In July CVS caremark® published a list of…
As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were…
On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar. The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer. The drug is made…
As we previously reported, on February 11, 2021, a three-judge panel of the Federal Circuit affirmed the District Court for the District of Delaware’s grant of Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165…
Sanofi announced that it has entered into an agreement to acquire Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, for an upfront payment of approximately $1.1 billion and up to $350 million upon achievement of certain milestones. The acquisition…
On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent. The EPO found invalid certain claims of Amgen’s European patent, EP 2 215 124, which is directed to PCSK9 antibodies. This EPO decision follows a ruling in…
As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex. In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…
We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection). Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market. SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product. SEMGLEE will be available in vials and pre-filled pens. The lead…
Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the EU.” Insulin aspart Sanofi contains the active substance insulin aspart, a rapid-acting insulin, and received marketing…