Novartis garners FDA clearance for generic version of three-times weekly Copaxone formulation

Novartis' Sandoz unit said Tuesday that the FDA authorised Glatopa (glatiramer acetate) 40 mg/mL as a fully-substitutable, AP-rated generic version of Copaxone 40 mg/mL, Teva's three times-a-week therapy for relapsing forms of multiple sclerosis. Glatopa was developed under a collaboration agreement with Momenta Pharmaceuticals.

"The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products," commented Sandoz CEO Richard Francis. In 2015, Sandoz launched Glatopa 20 mg/mL in the US as the first once-daily generic version of Copaxone.

The approval of Glatopa 40 mg/mL was delayed last year after Sandoz's contracted fill/finish manufacturing partner Pfizer received an FDA warning letter related to one of its US facilities. Novartis later warned that the delay to Glatopa 40 mg/mL would impact sales growth in its Sandoz unit.

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In October last year, Mylan gained FDA approval for the first generic version of the three-times weekly formulation of Copaxone. Meanwhile, earlier this month, Teva warned that sales this year will fall from $22.4 billion in 2017 to between $18.3 billion and $18.8 billion, partly hit by declining sales of Copaxone.

Commenting on the latest news, Baader Helvea analyst Bruno Bulic said "the earlier than expected authorisation (of Glatopa) and commercial launch might add an estimated $200 million to Sandoz' 2018 top line, translating in a low-single-digit divisional growth." Bulic added "we see ... Glatopa 40mg offsetting the Advair setback," after the FDA recently issued a complete response letter to a filing from Sandoz seeking clearance of a generic version of GlaxoSmithKline's asthma and chronic obstructive pulmonary disease therapy.

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