Generic Sovaldi (sofosbuvir)
Sofosbuvir (the original drug is sold under the brand name Sovaldi) is a new generation antiviral drug that is used as the basis for various treatment regimens for hepatitis C.
This inhibitor copes with blocking the pathological enzyme, minimizing the possibility of its self-reproduction. However, drugs containing only sofosbuvir do not exclude the ability of the virus to mutate. As a result, the virus is reactivated, the patient needs a new treatment that takes time and money. Therefore, Sofosbuvir is used in adult patients with all genotypes of the virus only as part of combination therapy. The drug is made in the form of tablets containing 400 mg of the active substance and is taken in the amount of one tablet daily with meals for 8-24 weeks. Together with sofosbuvir, combination therapy may include ribavirin, daclatasvir, ledipasvir, veltapasvir (NS5A inhibitors) and other components. The most common regimen is sofosbuvir + daclatasvir with and without ribavirin.
It should be emphasized that there are licensed and unlicensed generics. The difference is in the manufacturing process of the drug. In the case of sofosbuvir, Gilead issued a non-exclusive license to 11 pharmaceutical companies in India that are authorized to manufacture and sell the generic form of sofosbuvir and ledipasvir and on products containing sofosbuvir and ledipasvir in their factories and sell it for $900 for a 12 weeks treatment, in 91 developing countries of the world.
List of Indian pharmaceutical companies licensed and authorized to issue licensed generic drug sofosbuvir:
- Aurobindo Pharma Ltd
- Biocon Ltd
- Cadila Healthcare Ltd
- Cipla Ltd
- Hetero Labs Ltd
- Laurus Labs Ltd
- Mylan Laboratories Ltd
- Natco Pharma Ltd
- Ranbaxy Laboratories Ltd
- Sequent Scientific Ltd
- Strides Arcolab Ltd
Under the agreement, Gilead will provide Indian manufacturers with integrated technology for the production of new drugs. The licensee will set its own prices for generic medicines, with royalty payments amounting to 7% of sales. The license also allows the production of sofosbuvir in combination with ledipasvir and other antiviral drugs.
Gilead also compiled a list of 91 countries where licensed generics are allowed to be sold. There are no European countries in this list!
The first licensed generic Sovaldi for sale in India came in March-April 2015. The first sofosbuvir generic called Hepcvir manufactured by Cipla Ltd was approved by the Indian regulator in late March. In this case, the procedure for compliance with the original drug, confirming the stability and bioavailability of the active substance, took place in India for about 6 months.
In India and Nepal, Natco Pharma Ltd has launched sofosbuvir under the trade name Hepcinat. The manufacturer's recommended price in 2015 was $ 315, or $ 945 for a 12-week course. Today, the price for three packs of the drug when ordering online in India starts at $ 550 with delivery. Moreover, this price already includes the second component - daclatasvir.
The lowest price in Europe for the original sofosbuvir (Sovaldi) in Spain and Portugal is 25,000 euros for 3 bottles, while in a German pharmacy you will pay 56,500 euros for 3 bottles. Thus, the generic Sovaldi comes out 50-100 times cheaper than the original.
Today in the Indian market a fairly large number of generic sofosbuvir is available. Here are the most popular:
- SoviHep from Cadila Healthcare Ltd
- Virso by Strides Arcolab
- Resof, developed by Natco Pharma Ltd and manufactured by Dr Reddy's Laboratories
- MyHep by Natco Pharma
- Sofovir from Hetero labs
- Cimivir by Biocon ltd
By the way, almost all generics are produced in India at two plants: Natco Pharma and Hetero labs. The variety of brands of drugs is due largely to marketing considerations, so you can choose any, the most inexpensive of the drugs with sofosbuvir.
And in conclusion, it should be said: each decision is made at your own risk. When buying licensed generics, keep in mind that although they have been registered in India, they are not authorized for sale in Europe.