Oh Goody!!! Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar.
Just what the world needs another Valsartan disaster!
Couldn’t understand very much of the article. You clearly do. I guess it's bad? 😖
Personally, I don't think so really - it is a company looking to develop drugs that do the same as branded (and therefore still under patent restrictions and expensive) drugs already being used. That will make them significantly cheaper - and so more widely available.
The Valsarten problem is a different thing - it was a change in the manufacturing process that led to the contamination problem. It made headlines - but that shows it was found by the system.
And I'd expect the doctors employed by the company to be enthusiastic - if not, they should be looking for a new job. Regulations in Europe now do not allow "bribery" in the guise of marketing ploys. Struggling to get a pen these days!!!!
Hmmm? Perhaps. I have trust issues with China. Too may people (globally) making big bucks in Pharmaceuticals. My sister in law works for company that does drug trials here in UK and OH's cousin works for large US Pharmaceutical company. The stories I hear!!!!!! Don't have a lot of trust when there are large sums of money around.
Not so much bad as I don't trust what the quality will be... they will make Tocilizumab/Actemra "bigger, better, faster, cheaper." The original drug, as made by Roche, already has some skeletons in it's closet (like a lot of dead people that nobody knew about) so I am not so keen on it being made CHEAPER in China... but I am being over-reactive and painting with a broad brush!
: )
I had to Google Valsartan, as I was not familiar with the drug, nor the associated “disaster” 😕
aafp.org/news/health-of-the...
In general, does China have lower safety standards? I wonder, how many other drugs are manufactured there?
How many? A lot! And in India.
I don't think their safety standards are the underlying problem - medications are also checked by the importing countries. Their standards are what are applied then.
I'm sure you know more about this than I do PMRpro, but it seems that post-Brexit medication control is going to be a nightmare with components coming from various countries - many from India - with packing and preparation in others. Add to that the possibility that if ports get blocked too badly with lorries there are contingency arrangements to 'wave them through' (BBC News this morning) without checks . Small wonder that I'm going to be consolidating my steroid stash over the next few months and trying to work out how to stockpile my bisoprolol which I get only for 28 days at a time. But that's a small worry by comparison with those of people who are insulin dependent .
Well quite! No mention of this 2 years ago was there! And those of us who mentioned such points were scaremongering...
It seems that the supplier is already stockpiling insulin. I think an awful lot of this is scare tactics, we will have no salads it seems, or food in general will be scarce. Food riots......
I agree 100% it will be a nightmare... where there is £££, there will be corruption!
There have been a number of products recalled from China manufacturers; pet food, toothpaste, baby formula, toys, etc. They do hot have a good track record for making high quality products... and if they are trying to mimic a drug, but sell it cheaper than original manufacturer... they need to cut costs someplace! PMRpro is probably right, "medications are also checked by the importing countries," but I do not trust Theresa May or Donald's Trump's teams either!!!!! Too much ££££££ involved.
Signed, The Forever Pessimist
I'm hoping they cut costs by not having to do all the research that it took to come up with the original drug...probably being naive..
Fingers crossed... I'm a bit of a pessimist when it comes to large, global, companies and there's a LOT of money involved.
Me too.. Just considering how docs keep pushing statins and A.A. despite all the evidence of the harm they do makes me suspicious. My GP says she doesn't get a commission for prescribing statins, but I know first hand that docs (in Spain at least) get all sorts of gifts from pharmaceutical reps for prescribing certain meds.
But there is also a sort of trade war going on where countries falsely accuse each other about the safety of products, etc..
You just don't know who and what to trust! : (
Tocilizumab treatment extension, and latest PET-CT scan results
Discomfort vs flare in tapering of prednisolone 
Steroid sparing drugs.
LVV Does a flare come on suddenly?
