INDIAN IMBRUVICA

[fossicker]

A few months ago an article/post was published regarding an Indian Drug company filing for approval by USFDA for generic Imbruvica. Is anybody aware of how the approval has progressed ?.

cheers

[Marie_paul]

Hope so cause at my country imbruvica is not funded

[seelel]

No - there is no approved generic Ibrutinib in the US.

I have researched the subject of generic drugs and discussed the matter with a friend who is a senior pharmacist working in a pharmaceutical company.

The bottom line is that 90% of drugs sold in the US are now generics.

It saves the country billions of dollars, but unfortunately, generics may be biosimilar but not bioequivalent. Most generics are manufactured in India and China and drug fraud is rife.

So the pharmaceutical business is problematic as far as generics is concerned. It's a big subject and not possible to cover here. I just wish to wave a cautionary flag.

It is worth noting that generics don't go through clinical trials like brand name drugs. The FDA assess them purely on the data provided by the manufacturer.

If you want to understand the state of play then you might read 'Bottle of Lies' by Katherine Eban. It covers the rise of generics since the 1980's and traces them up until 2019.

[Hidden]

what you probably read was the article that said they would sue pharmacyclics in court for the right to make a generic version. This is under usa law that was passed years ago to encourage faster generic approvals. However it still has to go to trial and enough 'chips' in pharmacyclics patent must be found to get a judge to rule for them . It could still be several years

[bennevisplace]

Can't answer your latest post, but can maybe shed some light on Ibrutinib generics. In 2021 Abbvie won a key court case in the US, cementing Ibrutinib's market exclusivity in most countries until 2032 fiercepharma.com/pharma/don... The company may since have been wheeling and dealing, as recent statements claim patent protection only until 2028.

The main reason patent expiry dates come under challenge is that patent holders play dirty games in order to get the original term extended i-mak.org/wp-content/upload...

India is not like most countries. It has a drug manufacturing capacity sufficient to satisfy not only the large domestic demand but an even greater international demand for low priced generic drugs. Most of that is sold legally, some definitely not. In a recent case in the Indian Court, several firms were ordered to stop producing local versions of Ibrutinib m.timesofindia.com/india/sa... I doubt that any of these would have been available in the US or Western Europe. I'm guessing from your name you're in Australia?