The South African National AIDS Council has opened applications for local manufacturers to produce a generic version of the long-acting HIV prevention drug Lenacapavir, in a move officials say could expand access across the region.
Applications will remain open until 7 April, with local pharmaceutical companies invited to apply for licensing to produce the injectable treatment, which is administered twice a year and has been shown to reduce the risk of HIV infection by more than 99.9%.
While the initiative is aimed at strengthening domestic production and improving access in South Africa, SANAC says its impact could extend across Southern Africa, where HIV prevalence remains among the highest globally.
SANAC official Gertrude Mngola said the rollout could significantly improve prevention efforts if successfully implemented.
She explained that the final decision on licensing will rest with US pharmaceutical company Gilead Sciences, following a multi-stage evaluation process.
“Once manufacturers submit their proposals, they will be evaluated, followed by site visits. A list of manufacturers meeting technical criteria will then be forwarded to Gilead for independent assessment,” Mngola said.
She added that generic versions of the drug contain the same active pharmaceutical ingredient as the original product, with only inactive components differing.
“A generic is the same as the original. The only difference lies in the excipients, while the active pharmaceutical ingredient remains the same,” she said.
Mngola also noted that applicants who fall short of requirements will not be immediately rejected, but will instead be supported to improve compliance through technical assistance.
The injectable treatment has generated significant interest because it removes the need for daily pills, unlike current oral HIV prevention options that must be taken every day to remain effective.
She further explained that pharmaceutical patents, which typically last around 20 years, can delay access to medicines, but in this case voluntary licensing agreements allow for earlier production of generics in countries with high disease burdens.
“This is made possible through voluntary licensing, where originator companies enable generic production before patent expiry due to urgent public health needs,” she said.