by Oliver Yu
Biosimilars have entered the mainstream ever since their mandate was specified in the Patient Protection and Affordable Care Act (a.k.a ObamaCare).
Of the many things that ObamaCare mandated, one of them was that the FDA provide a regulatory approval pathway for biosimilars. Imagine that... a mandate for government.
In the United States as of the publication of this post, there is no way to introduce a biologic onto the market unless you are the person who came up with it... i.e the "innovator."
That's right. Pharmaceutical companies research the the drug, show safety/efficacy in the clinic, demonstrate cGMP compliance get the FDA nod to market the drug in the United States.
But when pharma drug patent(s) expire, other pharmaceutical manufacturers are permitted to seek FDA approval to sell the generic version... so long as they meet the rigors of FDA facility inspection and their application shows that they can produce the active pharmaceutical ingredient (API).
How do they know how to make the drug? The process isn't that simple, but you can figure it out from the aforementioned drug patents.
So why can't this be done for biologics?
The reason this putatively can't be done for biologics is because the active pharmaceutical ingredient is not made by a chemical reactions managed by humans. The API is made by chemical reactions managed by genetically engineered cells.
- For small biologics like insulin or hGH, E.Coli or other bacteria is capable of producing.
- Large biologics require mammalian cells like Chinese Hamster Ovary (CHO).
It stands to reason the cell line is locked for the innovator, it is locked for everyone else, hence a legal monopoly for biologics in the United States.
But back to the reason I blog about biosimilars. In 2008, I ran into an old friend (we'll call Morpheus) who worked at a big U.S. biotech company and he asked me if I remembered a mutual friend (who we'll call Neo). Back in the early 2000s, Neo had left to work for an overseas pharmaceutical company to lead their biologics development.
Morpheus was telling me that Neo's company had produced an exact copy of one of his company's flagship drug.
Me: "What do you mean, exact?"
Morpheus: "I mean it's closer to our clinical controls than our current manufacturing process."
What Morpheus was saying was that the competitor's drug matched the drug used to produce the successful clinical trial better than what the U.S. biotech company was manufacturing in 2008.
What was on everyone's minds at the time was industrial espionage. After all, it was against prevailing dogma that anyone could reproduce the biologic. But to replicate the drug better than the innovator... is insane.
I never heard about the allegations of industrial espionage again.
But what I do know is that the term biosimilars is a misnomer. They ought to be called, "Bioidenticals."
And this was back in 2008. Who knows how far these overseas companies pushed this technology?
One thing for certain is that the technical hurdles of protecting the biologics monopoly are falling. And with the ObamaCare mandate for a regulatory pathway for biologics, it appears that the regulatory hurdles are falling as well.