Generic HIV raltegravir medicines approved

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the first generic raltegravir medicines for adult and paediatric patients with HIV who weigh at least 40kg.

Authorisation of the antiviral medicine has been granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited.

Raltegravir generics – MHRA’s decision

MHRA stated that overall, when combined with other medicines, the integrase inhibitor raltegravir may minimise the quantity of HIV in the patient’s blood.

The active ingredient raltegravir is prescribed as a 600mg film‑coated tablet. The treatment must be used in combination with other medicines for HIV. Raltegravir generics have demonstrated bioequivalence to the reference medicine, according to the MHRA.

“Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with an already licensed reference medicine, called Isentress,” Shirley Hopper, MHRA Deputy Director of Innovative Medicines commented.

Approval of the generic raltegravir medicines is backed by evidence from studies in healthy volunteers, the UK’s medicine regulatory body noted.

HIV antiretrovirals – market availability

A 2019 study (applicable to England) predicted that by 2033, “most currently available [antiretrovirals] would lose market exclusivity; that is, generics could be available”.

It emphasised that financial efficiency concerning the cost of HIV medicines could be improved by “optimising generic use for treatment and prevention to mitigate the high cost of lifelong HIV treatment”.  Therefore, the authors stated, that “policy prioritisation should ensure timely generic switches and prevention of new infections, which will result in a corresponding curbing of spending on lifetime care”.

Other recent approvals for HIV medicines

In May, the MHRA authorised two new formulations for preventing HIV infection, Cabotegravir extended-release injectable suspension and tablets. Following the approval, ViiV Healthcare UK Limited highlighted that cabotegravir long-acting for PrEP is the first long-acting HIV prevention option approved in the UK that is injected intra-muscularly six times annually.