Africa’s biggest drug manufacturer, Aspen Pharmacare, has received regulatory approval for its generic injectable semaglutide in Brazil and South Africa, paving the way for commercial product launches within the next few months.
Business Day says this positions Aspen among the first entrants in some of the key generic markets opening up after Danish drug maker Novo Nordisk’s patent on semaglutide shots expired in many countries earlier this year.
Aspen was granted regulatory approval for its generic semaglutide jab in Canada in July and previously said it was seeking registration in about 20 more countries.
Aspen’s generic semaglutide has been registered for treating adults with type 2 diabetes, but doctors may prescribe it “off label” for weight management.
CFO Sean Capazario declined to disclose details of the company’s pricing strategy, saying only that it would be below that of Novo Nordisk’s previously patent-protected shots, branded Ozempic for diabetes and Wegovy for weight loss.
Aspen anticipated a “crowded” field of companies competing for a share of generic semaglutide sales, but lower prices were expected to drive an increase in the size of the market, Capazorio said.
The South African Health Products Regulatory Authority approved Ranbaxy’s generic semaglutide, branded Semagard, in July, followed in October by Novo Nordisk’s version, branded Semditu, according to a database on its website. The regulator said in July it was considering 12 registration applications for generic semaglutide.
Aspen’s generic semaglutide will initially be manufactured in India, but production will shift to its sterile facilities in South Africa and France later, Capazorio said.
The active ingredient in Mounjaro is tirzepatide, which mimics the effect of two gut hormones, GLP-1 and GIP. Semaglutide mimics only GLP-1.
Capazorio said sales of Aspen’s generic semaglutide weren’t expected to cannibalise those of Mounjaro, which it markets and distributes in South Africa and other Sub-Saharan countries under an agreement with Eli Lilly.
Business Day – Aspen gets regulatory nod in Brazil and SA for generic semaglutide