FDA approves first biosimilar product filgrastim-sndz
FDA News Release (03/06/15)
ESH is pleased to report that the FDA approved Friday filgrastim-sndz (Zarxio—Sandoz), the first approved biosimilar product in the United States. The drug is biosimilar to filgrastim (Neupogen—Amgen), which was licensed in 1991. Filgrastim-sndz — which is approved for the same indications as Amgen’s drug — can be prescribed for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing… Read More
The drug is made by Sandoz, formerly a 120 yr old Swiss drug firm that created the hallucinogenic drug LSD in the 1940s/50s when searching for psychotropics drugs that eventually led to its then-blockbuster, Mellaril, inter alia. Sandoz, which strictly makes generics now, has been part of conglomerate Novartis for several decades now. It also encompasses the former CIBA-Geigy.
Novartis manufactures such drugs as clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan) and imatinib mesylate (Gleevec/Glivec). Additional agents include cyclosporin (Neoral/Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others.
In 1996, Ciba-Geigy merged with Sandoz, and the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. Other Ciba-Geigy and Sandoz businesses were sold, or like Ciba Specialty Chemicals, spun off as independent companies. The Sandoz brand disappeared for 3 years, but was revived in 2003 when Novartis consolidated its generic drugs businesses into a single subsidiary and named it Sandoz. Novartis divested its agrochemical and genetically modified crops business in 2000 with the spinout of Syngenta in partnership with AstraZeneca, which also divested its agrochemical business.
The first barrier has finally been broken in the patent monopolies Big Pharma-Biotech has had in the faster growing and most expensive part of the drug industry. Teva has been, so far successfully, blocking biosimilar copies of its MS drug, Copaxone.
ESH instructs readers to look for that barrier to be broken later this year.