The South African Health Products Regulatory Authority is reviewing 12 applications for generic versions of semaglutide, with an Indian pharma giant being the first to get the greenlight to sell a cheaper version of the drug in the country.
Novo Nordisk’s patent on semaglutide, used in diabetes drug Ozempic and weight-loss treatment Wegovy, expired in March in South Africa, allowing drugmakers to flood the market, reports News24.
Last week, India’s Sun Pharmaceutical Industries became the first company to receive the green light from SAHPRA to manufacture and sell a generic version in South Africa: it’s hoped more generic application approvals could mean lower-cost alternatives here and boost competition in the market dominated by Novo and US rival Eli Lilly (Mounjaro).
Reuters reports that the green light from SAHPRA makes South Africa the second market, after India, where Sun Pharma has secured clearance for a generic semaglutide injection, approved for adults with inadequately controlled type 2 diabetes.
Sun Pharma said it will be launching the product in South Africa within days, the medicine to be sold as a pre-filled, multi-dose injectable pen in two strengths – 2mg and 4mg – for once-weekly use.
The local weight-loss drug market is dominated by Lilly’s Mounjaro and Novo’s Ozempic and Wegovy, though the products face growing competition from compounded versions of the medicines.
Novo plans to launch a more affordable authorised copy of Ozempic in South Africa this month through a partnership with healthcare company Acino, aimed at expanding patient access. It has also cut the prices of Wegovy to make it more accessible.
Aspen scores Canadian approval
South Africa’s Aspen Pharmacare’s Canadian subsidiary, meanwhile, has received regulatory approval from Health Canada for Aspen-Semaglutide, a generic version of Ozempic, reports Reuters.
The expiry of Novo’s patent for semaglutide has opened the door for several companies looking to enter the Canadian market with generic versions.
However, the timing of Aspen’s commercial launch in Canada remains dependent on the availability of semaglutide active pharmaceutical ingredient (API) supply from India’s Dr Reddy’s Laboratories, the company said.
Earlier this month, Dr Reddy’s said supplies of its generic semaglutide would remain unavailable in India and face disruptions in Canada until at least late October after an impurity issue in the active ingredient halted production of new batches.
In March, Aspen’s CEO Stephen Saad said Aspen’s generics would be manufactured at its South African and French facilities, with the bigger volumes via multi-dose pens set to be produced at the South African facility.
The French facility will produce single-dose auto-injector medicine.
The companies already face stiff rivalry, worldwide and including in South Africa, from compounded versions of the medicines.
A huge public education offensive is being planned to counter this, reports Business Day.
“Judging by the reports from consumers and seizures conducted by inspectors, the issue is widespread, and the campaign aims to educate the public and reduce the risks associated with these products, especially those sold online and on social media platforms by unregulated suppliers,” said SAHPRA spokesperson Rodgers Baloyi.
The regular will be roping in consultants to drive messages within communities about the proliferation of illicit medication and medical devices in what will be its biggest media blitz yet, delivered via national radio stations in all 11 official languages.
The multimillion-rand campaign will run for four months annually for three years, with the first month of each year dedicated to planning, according to the request for proposal.
The National Regulator for Compulsory Specifications (NRCS) is also ramping up its efforts to “lock out” non-compliant products and encourage local manufacturing, saying that an estimated R382bn worth of illicit/non-compliant products is traded annually within the NCRS regulatory space, gobbling up R700bn of GDP annually and causing about R100bn in losses to the fiscus.
The National Consumer Commission is also laying the groundwork to implement the country’s first track-and-trace system as part of a co-ordinated crackdown on illicit goods, particularly counterfeit medication and pharmaceuticals.
News24 article – Dozen weight-loss generics being reviewed for SA (Restricted access)
Reuters – India's Sun Pharma wins South Africa approval to launch generic Ozempic
Business Day – Fake HIV, pain and weight-loss drugs — Sahpra is fighting back
See more from MedicalBrief archives:
Public health threat as South Africa battles illegal weight loss drugs
Ozempic goes generic for billions of people worldwide
Aspen sets its sights on Canada for generic weight-loss jabs