Question about biologics

Hi people…

I was wondering if the reason for biologics being expensive and therefore difficult to get subsidised by the government was because it is still under patent?
Is it that it is still being made and sold by the first company under patent? I am told these patents last 10 years and after that time every-man-and-his-dog start manufacturing it and it appears in chemists under different brand names at a reasonable price.
Is this the case? And if so how long left on the patent?

Or are you going to tell me bad news as I am unaware of these particular compounds are complicated and will never become cheap?

Hi Nickace,

Assuming you are an Australian citizen, this really shouldn’t be your worry (though I realise on rare occasions it can). Yay for the pbs!

Unfortunately, though, your last paragraph seems to have hit the nail on the head though, in Australia at least.

The patents I believe are usually 20 years, and can be renewable.

But even biosimilars (which unlike generics, are not exactly the same, and may have a slightly different effect on the same person), are reportedly only around 10-15% cheaper (I was having a conversation about this with my Rheumy last visit).

Assuming you don’t have something barring your access to the pbs, it is worth googling up a copy of the application for biologics form to see how the rules work.

@Jen75 PBS?
Is that the name of the scheme that gets you the bios?
I have no baring I’m aware of. I am an Aus citizen. Obviously that’s important.

I’m just concerned about this since all the research I’ve done and all of your input seems to indicate that bios are the thing that will actually fix me and all the dmards are just the stepping stones to get there.
My dad’s friend was a lifetime skin psioriasis sufferer. It was all over (even his genitalia) he got into a clinical trial and it’s all gone.

The 2 other people I’ve spoken to with mainly tendon involvement all say bios changed their life.

I do remember you sending me some forms when I first jumped on here over a year ago.

I read the form you sent a while ago.
If is still current

I feel better about it now

If it helps @nickace the NHS in the UK are switching everyone over to biosimilars for those drugs which are off patent and where biosimilars are now being produced solely based on the cost of the drug. And here we do have a protocol to follow which means failing DMARDS AND still having a considerable ‘active’ disease too before the NHS will fund us on the biosimilars and indeed any other drug still on patent. And all this is because these drugs are very complex and consequently therefore very expensive.

But it is useful to remember loads of people actually do do well on just DMARDS too. Hence the necessity of all funding entities including most medical insurers to at least give the DMARDS a decent shot.

Hi Nickace, I’m sorry I haven’t had time to look it up, but have seen no mention of changes (and my Rheumy said nothing to me a couple of weeks ago when I saw him - I’m still merrily taking Cimzia).

Biologics are one of the most expensive groups of meds on the pbs for the consumer, but I still pay only $40 every 4 weeks ($7 if you are on a concession card), and I feel very grateful for that.

We are lucky, despite the hoops we have to jump through to get there, and I’m sure you’ll be just fine if it comes to that.

The patent on discrete pharmaceuticals is 7 years. Sometimes the manufacturer can get an extension. 10 years would be unusual.

I take Orencia. My co-pay is US$1,735/month. I was also approved for Humera. My co-pay for Humera would be US$2.450/month.

Drug manufacturers do not always rush in with a generic. Sometimes first in the market with a drug confers dominance which is hard to dislodge. The follow on manufacturers never obtain a patent. The sell on price. Sometimes if made in the Pacific Rim or eastern Europe, drug content is not reliable.

So I guess your rheumatologist didn’t tell you about Enbrel’s dirty little game…there are three developers/owners, but when they applied for patent, they only put 2 on application. When it was set to expire, they took out in 3rd person’s name. There are now things in place to prevent this in the future.

You may never have to start Biologics. For some, they have great success with DMARDs. There is not a cure, so no complete fix…and the goal is not to be pain free, but to have quality of life while limiting the destruction to joints on a medication that works with the least long-term side effects.

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My problem with generics is that they are allowed to provide 20% more or 20% less of the actual drug. Unfortunately, most insurance makes you get generics rather than the name brand because they are for-profit organizations. So with generics, you and your doctor are never sure how much medicine you are actually getting. This could contribute to interactions with the other drugs you take.

In the UK, we’re treated by the NHS, it’s a not for profit organisation funded by the tax payer and the government and free to the end user/patient regardless of income, and we are basically offered biosimilars (not generics) of some biologics that are available, obviously for cost reasons too. I don’t think there are any ‘generics’ of biologics yet, just biosimilars. So consequently as it’s a biosimilar and not a generic, the drug dose is very positively monitored. Having only taken a biosimilar for enbrel called Benepali, I have to say it’s working presently rather well. So I’m happy and indeed more than happy too that my treatment costs the NHS less too, than if it only had enbrel to offer me.

You are incorrect about generics.

In the USA at least to be considered a generic interchange the active ingredient must be EXACTLY the same.

The 20 percent difference is in inactive ingredients. Even then the inactive ingredients come from a limited list of options selected based on how the react to the active elements.

An example of inactive ingredients would be binders, dyes, and the capsule.

The active ingredient must be identical.

Patents run from 15 to 20 years and were originally designed to recoup R&D costs. Things have run amuck the last two decades and become a price fixing scandal. I have hopes the price gouging will come under attack soon as it’s completely out of hand.

I’ve worked in the pharmacy for 15+ years and have rarely seen a legit reason to not use generics. An allergic reaction to an inactive element is about the only thing I’ve seen.


Wow, good to know. I was misinformed by my psychiatrist.

Believe it or not, it’s a common misunderstanding in the medical field, I run into all the time, it makes me want to pull my hair out.

My advice? Always remember you doctor knows diseases, your pharmacist knows chemicals – never take your doctor’s word for it on meds, always double check with a pharmacist. After all, you wouldn’t let your pharmacist diagnosis your condition, don’t let your doctor advise you on your chemicals. Doctors know what meds are used for a given condition, they don’t really know the nuts and bolts of the meds, that’s your pharmacist.


Oh dear you said psychiatrist, thats a horse of a different color. Granted I haven’t followed this whole thread. Why (I don’t know why even after spending years in R &D) Psychotropics and anti siezure medicines are different that regular old generic is a mystery.

Especially the anti siezure medicines used extensively off label for nerve pain ARE different (active ingreients aside) A siezure patient for example will often start siezing with a simple change in generics. (As a recent 4 day hiospitalization my grandaughter had when her pharmacy change generic lamicdol without notification proves)There is a a lot more to inactive ingredients than meets the eye. Consequently many docs in this field specify no substitute and in the USA are backed up by legislation.

In any event Biologics will NEVER be cheap as they are all some monoclonal something, and they are “grown” not chemically duplicated. The process can’t change. At best, Biosimilars which stand a snowballs chance in hell of being approved in the USA anyway are usually only 10% cheaper (some may be in the 15% -20% range). Little difference to the patient as there are few if any assistance programs (in the USA) availble for generic/biosimilar meds leading actual higher costs) Interestingly the common biosilars in the US are being made by the same companies makeing the original. But that savings is a huge difference to say a National Health care plan. An on the ball pharmacy would NOT change generics without direction/physician approval


Funny you mentioned Lamictal, I’ve been taking it for over 15 years. Some versions cause WAY more dizziness when rising or sitting. I’ve passed out twice in the last 7 weeks due to a change in pharmacy caused by my moving to a new city - getting divorced :frowning: - and the version of Lamictal I am getting, rather Lamotrigine. I always get nervous when the pharmacy switches manufacturers which happens a lot. I have noticed a huge difference when it comes to Clonazepam. Risperidone seems to be pretty ok no matter where it comes from.

There can definitely be difference in how your body reactions to inactive ingredients – one of the worst allergic reactions I have had was to a change in manufacturer for a drug I had been taking for 5+ years.

You can ask your pharmacy (any pharm, be it local or home delivery) for a specific manufacturer, you can even have your doctor write it on the prescription itself and it will be ordered in for you, you don’t have to take what they stock.

It’s hard to say what makes the difference in how meds work. For example, the idea used to be that patients should stay on the brand name coumadin because the generic “didn’t work as well” but very recently it’s been figured out that brand or generic isn’t the issue, genetics is the issue, a person with a certain gene doesn’t respond to that med as expected… so it’s all a work-in-progess, so to speak.


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