A worldwide forerunner in generic pharmaceuticals and biosimilars and a division of the Novartis Group, Sandoz, publicized today how the U.S. District Court of New Jersey decided against the company in a lawsuit related to Erelzi®. Erelzi is the Sandoz biosimilar of the reference drug Enbrel®. Sandoz has decided to appeal the judgment to the United States Court of Appeals for the Federal Circuit. Both the parties have settled for a quickened appeal.
The President of Sandoz U.S. and Head of North America, Carol Lynch, stated how the company respectfully differs in opinion to the judgment passed by the U.S. District Court of New Jersey, according to which the company is prohibited from initiating an additional choice of treatment for patients suffering from autoimmune and inflammatory ailments.
She added how while genuine intellectual property should be given respect, Sandoz considers the patents in this particular case to be invalid. She concluded how the company looks forward to presenting their case to the Federal Circuits so patients can enjoy the benefits of Erelzi as soon as they can.
The FDA approved Erelzi on the 30th of August 2016 for all indications included in the reference product label at that time. It is the very first biosimilar firm granted Food and Drug Authority’s permission for a biosimilar etanercept. The drug, Erelzi, has been permitted for about 3 years, but Sandoz has been incapable of selling it due to the continuing patent lawsuit from Amgen.
Biosimilar play a significant part in allowing an increased number of patients access to biological drugs, in a world where drug prices are skyrocketing. This may also aid in lessening the burden on the already stressed healthcare system. For instance, the usage of biosimilar Zarxio for clinical practices saved nearly $500 million for the United States in a time period of less than 2 years.