Novartis’s Sandoz division has won U.S. approval for a larger dosage of its Glatopa drug for multiple sclerosis (MS) patients, ending a costly delay that will allowed rival generics makers to beat the item to market.
The U.S. Food along with Drug Administration (FDA) approved a 40 milligrams per milliliter injection of the Novartis copy of Copaxone, Teva’s blockbuster medicine, Sandoz said in a statement on Tuesday.
Sandoz began selling a 20 mg/ml Glatopa dosage to U.S. patients with relapsing MS in 2015 however missed out on millions of dollars in sales after the double-dosage product was pushed back last year after contamination problems at the Pfizer fill-along with-finish plant being used by Sandoz.
The FDA approval, which Novartis had expected from the second half of that will year, could help to compensate for the recent FDA delay of a Sandoz product of GlaxoSmithKline’s asthma along with COPD drug Advair, analysts said. The drug’s launch will be currently unlikely before 2019.
“The earlier than expected authorization (of Glatopa) along with commercial launch might add an estimated $0 million to Sandoz’ 2018 top line, translating in a low-single-digit divisional growth,” said Baader Helvea analyst Bruno Bulic.
“We see … Glatopa 40mg offsetting the Advair setback along with reiterate our buy rating.”
Novartis developed Glatopa with Massachusetts-based Momenta Pharmaceuticals.