Melissa Barber (@mbarber.bsky.social) Profile picture
Postdoc @YaleLawSch @YaleMed @Yale_CRRIT researching econ, law, & medicines • she/her Past lives @Harvard @PORTAL_Research @FXBHarvard @WHO @MSF @GlobalFund

Aug 4, 2022, 12 tweets

Pharma is really good at creating narratives with half-truths (or just outright lies) that narrow the policy space to their desired outcome.

So good that even @jacobin- a rare US socialist magazine-has accidentally repeated a few of their greatest hits. A (gentle) correction 🧵1

Let's unpack this:

"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

A nice paper exploring/explaining this is pubmed.ncbi.nlm.nih.gov/21441787/.

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

southcentre.int/research-paper…

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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