Lupin Healthcare and Zentiva Pharma UK have received the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approval for their generic HIV drug, Isentress (raltegravir).
Isentress is an antiretroviral medication indicated for the treatment of adults and paediatric patients with HIV/AIDS, who weigh at least 40kg.
The UK regulator recommended the drug in a 1,200mg dosage, taken as two 600mg film‑coated tablets orally once a day, in combination with other medicines for HIV.
According to the UK regulator, the Human Immunodeficiency Virus (HIV) produces the HIV integrase enzyme, which promotes the multiplication of the virus in cells within the body.
Isentress works to reduce the function of HIV integrase and may reduce the amount of HIV in the patient’s blood and increase the patient’s CD4-cell count when used with other medicines.
The CD4 cells are a type of white blood cells that play a key role in maintaining a healthy immune system.
MHRA innovative medicines deputy director Shirley Hopper said: “Ensuring timely access to generic medicines is a key priority for us.
“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. As with all products, we will keep the safety of raltegravir under close review.”
The MHRA approved Isentress based on evidence from studies in healthy volunteers, which involved tests to determine the drug’s bioequivalence to the reference medicine.
In the studies, raltegravir generics have been bioequivalent to the reference medicine, their benefits and possible side effects are the same as the reference medicine.
Furthermore, MHRA said that it will closely review the safety and effectiveness of raltegravir.
In a separate development, Lupin announced that its alliance partner, ForDoz Pharma USA has received the US Food and Drug Administration (FDA) approval for its generic cancer drug.
The US health agency approved the company’s Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20mg/10mL and 50mg/25mL single-dose vials.
Doxorubicin HCL Liposome Injection is indicated for the treatment of ovarian cancer, acquired immune deficiency syndrome (AIDS)-related Kaposi Sarcoma, and multiple myeloma.
The drug is a generic equivalent to Baxter Healthcare’s Doxil Liposome Injection, 20mg/10mL (2mg/mL) and 50mg/25 mL (2mg/mL).
