Greg Jefferys Hepatitis C blog deals with all the issues associated with hepatitis C
An authorized generic Hep C drug is a Hep C drug that is of exactly the same chemical composition as a Hep C drug that is protected by medical patents. Generic Hep C drugs are allowed to be manufactured in countries where the patent holder has granted a license or in countries where a patent has not been granted for the particular Hep C drug. In the USA and most other countries authorized generic Hep C drugs can be purchased and imported for personal use. For more information about importing Hep C generics into your country click here to email me.
An example of licensed Hep C generics are the generic versions of Gilead’s Epclusa and Harvoni made in the USA by, Asegua Therapeutics. Asegua was licensed by GILEAD to make authorized generic versions of Epclusa (Sofosbuvir + Velpatasvir) and Harvoni (Sofosbuvir + Ledipasvir) to compete with AbbVie’s pan-genotype Hep C drug Mavyret.
Asegua Therapeutics’ Hep C generics are made in California and sell for around US$20,000 for a 12 week treatment, around the same price as a treatment of Mavyret.
There is only other place in the world, outside the USA, where authorized Hep C generics are made, that is in India. The reasons why GILEAD authorized selected Indian pharmaceutical manufacturers to make Hep C generics is a long story. If you wish to read GILEAD’s explanation click here.
The short story is that India initially did not recognize the patent on Sofosbuvir, which led to extensive negotiations between Gilead and Indian Pharma companies. These negotiations ultimately led to GILEAD supplying India with all the technical data for manufacturing Epclusa and Harvoni and Sovaldi in exchange for a royalty.
So India is the only country in the world outside of the USA where authorized Hep C generics are made. Importantly Indian Hep C generics are exact replicas of the original patented versions of Epclusa, Harvoni, and Sovaldi.
Indian Hep C generics are chemically identical to GILEAD’s Epclusa, Harvoni and Sovaldi and also identical to Asegua Therapeutics’ Hep C generics and give exactly the same cure rates as Gilead’s brand versions of Epclusa and Harvoni
Not all Hep C generics are equal, the authorised Hep C generics are exact replicas of the branded medicines whereas unauthorised Hep C generics are not exact replicas.
There are several reasons for this.
Firstly the makers of unauthorised Hep generics do not have access to the manufacturing technology from the patent holders that the makers of the authorized Hep C generic meds have.
The other reason is that unauthorised generics are mostly made in countries that have poorly regulated pharmaceutical industries, for example, Egypt has a very poor reputation for making pharmaceuticals.
I remember once when I met the head of the product development of one large Egyptian pharmaceutical company. After our meeting, she gave me her business card and asked me to send her an email. I tried to send her an email but the email kept bouncing back… I later discovered that there was a typographic error on her business card. Her email address was misspelled!
I wonder if I would trust someone making complex chemical formulations if they could not get their business cards printed correctly?
Unauthorised Hep C generics are generally cheaper than the authorised generics because the makers do not have to pay a royalty.
I would suggest that saving a few dollars is not worth the risk of buying a sub-standard Hep C generic that may not actually produce a cure.
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