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Novartis, Momenta grab a delayed FDA OK for blockbuster Copaxone knockoff

After a long delay, Momenta $MNTA and Novartis $NVS have finally received an FDA green light for its Copaxone copycat, catching up with Mylan in slicing shares of the multiple sclerosis market from struggling Teva.

Sandoz, the generics unit of the Swiss giant, and Cambridge, MA-based Momenta promptly announced a US launch of the 40 mg/ml dose early Tuesday, right as they celebrate the win. A lower dosage (20 mg/ml) of the drug is already available commercially, but it is the 40 mg/ml version that competes directly with Teva’s blockbuster drug.

Craig Wheeler

Contamination problems at a Pfizer fill-and-finish plant that makes the larger Glatopa dosage pushed back the partners’ plans to gain approval in 2017. The compliance issues were cleared last month.

For Sandoz, this approval might help sooth the pains from the recent rejection of its knockoff of Advair — GlaxoSmithKline’s asthma and COPD drug — which represented another lucrative market.

“The earlier than expected authorization (of Glatopa) and commercial launch might add an estimated $200 million to Sandoz’ 2018 top line, translating in a low-single-digit divisional growth,” Baader Helvea analyst Bruno Bulic told Reuters. “We see … Glatopa 40mg offsetting the Advair setback and reiterate our buy rating.”

It is also a much-needed win for Momenta, which has wound down a long road littered with successive partners since it originally signed a $452 million deal in 2011 to collaborate with Baxter on the then nascent field of biosimilars. Shire picked up those rights when it bought out Baxalta, which was spun out of Baxter, then punted them in the fall of 2016.

“This approval further validates the strength of our physicochemical and biological characterization capabilities,” said Craig Wheeler, Momenta’s president and CEO, in a statement.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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