"The sheer complexity of insulin production makes it financially unviable for generic companies. Thus, instead of generic insulin, we speak of biosimilar insulin — a biosimilar is a biologic drug that is extremely similar but not identical to the original." 2
First, generic insulin markets are 100% financially viable. I hate to be that academic that says "I have a paper on that" but gh.bmj.com/content/3/5/e0…
We assume a 10% profit margin (which is more than average) & estimate costs at ~$3/vial for NPH + $5 for glargine. V. viable! 3
"Generic" markets just refer to competitive markets (ie, markets where the state doesn't enforce a monopoly allowing the patent owner to set the price at whatever the market will bear).
Actual footage below of generic vs biosimilar markets (they're the same thing). 4
Why we use "biosimilar" (instead of generic) is complicated, but tldr is mostly bc of a phenomenally successful lobbying campaign by pharma in the 80s/90s to get more expansive monopolies.
It was NOT coined bc generic markets couldn't compete. They 100% could and do compete. 5
Industry has always insisted that we use "biosimilar" instead of "generic" bc biosimilars aren't "the same" as biologics in the same way generics are "the same" as reference small molecule drugs.
The idea of "difference" is complex and has scientific and economic dimensions. 6
Scientifically, this biologic/biosimilar difference is in one sense true: no 2 things made w/living organisms are exactly the same.
HOWEVER, this logic also applies to reference biologics: every new batch of ref product is effectively also a biosimilar (& not "the same") 7
Difference is ok! There are slight variations b/w approved biosimilars and reference biologics. But these variations are of similar scale to variations WITHIN reference biologics across production batches.
What we care about is that the drugs work equally well and are safe. 8
Fig 2 plots one specific glycan structure in a commercial mAb followed in many batches over a 4y period.
"It is apparent that originators are essentially manufacturing biosimilars of their original product." 9
For these reasons, folks (including historically WHO) use the more neutral "biogeneric"
@scgva2011 of @South_Centre writes abt the politics & stakes of the regulatory confusion, delays, & added protections pharma succeeded in securing w/the new label. 10
Economically, by insisting that this difference mattered enough to merit a completely separate set of rules, pharma was able to secure more protectionist / profitable terms than they had w/generics.
The distinction was also exploited to scare ppl off cheaper biosimilar drugs. 11
I am 💯 here for bold thinking abt what we can do to guarantee #insulin4all for everyone, everywhere, now.
And YES: "Creating public drug companies is not pie-in-the-sky fantasizing."
Public production is viable: other countries have done this for decades & the US can, too.
12
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Since Modi came to power, the entire approach to infectious diseases has radically changed. In 2014, the health minister, Harsh Vardhan, controversially argued fidelity in marriage was more important than condom use in preventing AIDS & proposed a ban on sex education. 2/
Adverts promoting condom use, safe sex, etc, have completely disappeared from public discourse. Everything is about Ayushman Bharat and insurance coverage.
Around 2.4 million Indians now live with HIV. In 2022, there were around 60k new cases and over 40k deaths—most from TB. 3/
It's wild and bad that Biontech tried to get public mentions of #CTAP, a @WHO housed initiative to pool intellectual property, scrapped as "vaccine misinformation".
This is not the pharma's first bizarre anti-generics campaign. A quick bit of history.🧵1/
9 months later, no real news.
❌generic supply is still not widely available
❌Pfizer is refusing to expand licensing
🥴no trial data on how it works in key populations
Here's the top-line summary, using current prices of API traded in global markets.
#Paxlovid is $530 in the US. It has been reported that in China right now, desperate people have been paying as much as $7,000 to get it for their loved ones. 2/ reuters.com/business/healt…
Cost-based estimated generic prices use the price of active pharmaceutical ingredient (API) traded in global markets, and a cost estimation algorithm we developed in earlier research (see gh.bmj.com/content/3/1/e0…)
Costs come down exponentially when there is competition, but.. 3/
I saw videos I posted retweeted out of context, so I want to be clear abt a few things.
What has happened this week is pharma's failure to show up & be transparent abt contracts and pricing has fanned the flames of of distrust about vax effectiveness.
I encourage folks to read the linked tweet (above) on the transmission q.
I really wish MEPs had the opportunity to pose questions to someone who had been involved in the R&D side of things rather than the business side of things so their questions could have been answered. 2/5
BUT I want to correct the record bc some news has reported on the committee meeting as if it were entirely abt that, when in fact most MEPs were focused on concerns abt democratic process: public money shd be accounted for in transparent contracts. 3/5
1) member states are furious by the lack of transparency & #SMSgate 2) @AlbertBourla miscalculated that this was something he could skip. 3) The committee is ready to recommend consequences
Summary in 🧵1/
I don't usually do full 🧵 detailing hearings (apologies in advance), but what happened yesterday was pretty extraordinary and I think will be important in setting the course for ongoing future pandemic planning.
"I must say that it is a disgrace that @AlbertBourla is not with us today and an even greater disgrace that he doesn't have any real intention of showing up." 3/
1 in 4 teens are forced to leave home after coming out.
Many ppl under 26 are on their parents' health insurance, making coming out even scarier than it already is bc it might mean that you need to find new insurance fast- not easy & $ in the USA (3/11)