The Argentine drugmaker Gador has launched a generic Spinraza, a competitor for Biogen’s blockbuster spinal muscular atrophy treatment. With the brand name Ligonux, the product has been approved and launched in Argentina just eight years after the FDA first approved Biogen’s original in the US.
Biogen’s Spinraza has competition in Argentina. The local drugmaker Gador has launched a generic of the spinal muscular atrophy drug under the brand name Ligonux. Launched at an event attended by pediatric neurologists at the Centro Audiovisual Inmersivo de Buenos Aires today, it’s the only generic Spinraza outside of Russia.
The launch event was led by company director Alfredo Weber, while speakers included Soledad Monges, head of neurology at Hospital Garrahan, Mariela Lucero, head of pediatric neurology at Sor María Ludovica de La Plata Children’s Hospital and Natalia Messina, the former director of special and high-cost medicines at Argentina’s Ministry of Health. The latter official played a key role in shaping the shared risk model for high-cost treatments. See article in Spanish.
It’s not yet been a decade since the FDA first approved Spinraza, and the only generic Spinraza so far has been in Russia. In July, Biogen lodged a lawsuit against the Russian company Generium in a bid to block the product. See article in PharmaLetter
Gador’s product will also compete with Zolgensma from Novartis. Approved only for newborns, this one-shot therapy has been hitting Biogen’s Spinraza sales internationally for some time. The other main player in the area is Roche’s Evrysdi, an oral treatment that was approved in Argentina last year.
Biogen’s local director Andrea Da Pieve will have to recalculate. Gador has been busy working Argentine media, promoting its Spinraza generic as a national product, although it’s evaded technical explanations of the process involved in its creation. The company will also be negotiating with local health insurance and social security providers to provide a competitive price. As for public tenders, the last one was in August 2023, when Biogen won a deal for 120 units of Spinraza for $ 5.4 million.
For now, Spinraza remains Biogen’s second-biggest selling product, contributing 21.3% of all revenue. That puts it just behind Tysabri (24,7%). In third place is Tecfidera – also for multiple sclerosis (14%). In the first half of 2024, Spinraza sold $ 770.4 million, down -12,5% from $ 880.4 million in the same period of 2023.
