Why no generic?

[nogutsnoglory]

Why is this drug still do expensive? It was FDA approved in 1998. I thought companies have 5 years of sole copyright before others can manufacture generic equivalents.

Humira was approved in 2008 so next year would be generic year unless companies don't want to bother because it's too expensive too produce.

 

[Lisa]

Why is this drug still do expensive? It was FDA approved in 1998. I thought companies have 5 years of sole copyright before others can manufacture generic equivalents.

Humira was approved in 2008 so next year would be generic year unless companies don't want to bother because it's too expensive too produce.

what I have found -

In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.



Read more: http://wiki.answers.com/Q/How_long_before_any_drug_becomes_generic#ixzz20JZ7kmoc

 

[DustyKat]

Blockbuster biotech drugs with patents soon to expire include Roche’s blood cancer and rheumatoid arthritis medicine Rituxan (rituximab) and Merck and Johnson & Johnson’s anti-inflammatory drug Remicade (infliximab). Patents on Rituxan expire in the US in 2013 and on Remicade in 2012, while both have patents expiring in Europe in 2014. Amgen and Pfizer’s rheumatoid arthritis drug Enbrel (etanercept) will already lose patent protection in Europe in 2012, with US patents expiring in 2014, see Figure 1. These three drugs alone are reported to have worldwide sales of more than US$5 billion annually [1].

http://gabionline.net/Biosimilars/General/Market-opportunities-for-biosimilars

Dusty.

 

[nogutsnoglory]

Hmm I wonder where I got the 5 year idea. I was pretty confident that I learned that in a class once.

I am glad remicade patent is expiring this year. Any clue how long till they usually take to offer a generic?

 

[Lisa]

I've read on some sites that because it is a biologic, it doesn't fall under the same rules as far as generic.....may do a little more research on that when I have a minute....supposed to be working right now lol.

Interesting read here - http://www.kevinabarnes.com/2009/11/20/is-generic-remicade-in-our-future/

 

[moogie]

So we are, I mean my insurance company is doomed to have nightmares of me using Remicade forever

My last treatment cost my two insurance companies 9999.99$ and that is every 6 weeks!!

 

[stefan]

Some pharmaceutical patents (biologics in particular iirc?) can have a longer life than other patents, which is probably where the confusion comes from.

Also there's the questionable process of "evergreening" these patents which is where the patent holder makes subtle and largely inconsequential changes to the patent, and starts the clock counting down all over again.

I'll find some sources when I'm at a computer, but in short: patents are nasty.

2

 

[Misty-Eyed]

You can't actually get a generic version of a biological drug. They are called biosimilars.

Unfortunately they will not be as cheap as generics either. Companies wishing to produce biosimilars have to stump a lot more cash for studies to prove that the drug they wish to produce is an actual biosimilar to the one they effectively copying, than for a generic.

But saying that, the first biosimilars shall be seen very soon, so will see what happens!

 

[ThanksP]

My Remicade nurse told me today that the company who makes Remi will have two injectables out in 2014. She said the rep told her that the new injectables are for patients who didn't respond to Remicade.

 

[nogutsnoglory]

My Remicade nurse told me today that the company who makes Remi will have two injectables out in 2014. She said the rep told her that the new injectables are for patients who didn't respond to Remicade.

How does she know when they will be FDA approved? Are these biologics as well anti TNF?

 

[Misty-Eyed]

How does she know when they will be FDA approved? Are these biologics as well anti TNF?

I don't know that much about the actual approval process in the states, but in the EU biologics will go through a certain time frame for the approval process. I'm assuming it would the same in the states.

Saying that, there's obviously no guarantee that the drug will be approved for use in Crohn's or approved at all. I think it's more likely that it would be approved in the states than in the EU though, such as Cimzia. I don't know why the FDA is more favourable.

I do actually know someone who is working on it in the Netherlands. Maybe I'll have to send him an email!

 

[kiny]

Older thread. But there is a biosimilar of remicade now, called CT-P13.

http://www.celltrionhealthcare.com/PRODUCTS/CT-P13/PATIENT/Product/product.asp

from a Korean company

Remicade actually has only patents enforced in certain countries, in many countries they do not have patents approved, in Eastern Europe Janssens is not protected by patents for example. That's where that Korean company will launch it's products first, they're waiting on approval now from their studies.

Although most doctors are already against biosimilars, ECCO already said they wouldn't support biosimilars basically, and since ECCO is nothing more than a front for big pharma from Europe, the doctors are paid by big pharma, the drama already starts.

The patents on remicade expire completely in 2015, Janssens asked for half a year extension and got it, remicade patents were supposed to expire in 2014, but again, remicade only has patent approval in a select few countries.

I hate hate hate, writing about things like this, it's all about money.