Boston Business Journal has a story today about a Woburn, Mass., company called Blue Stream Labs that is expanding as it works to develop something I had never heard of: “Biosimilar” generic drugs:
Unlike making a generic of a small-molecule (or pill-based) drug, which is made from chemicals, replicating a biologic molecule produced from living cells is much more complex. “When the patents run out and companies try to copy it, it’s likely they won’t be able to copy it exactly as with a generic, because it’s manufactured in a cell,” Kouchakdjian said. “The copy is going to be different. That’s why it’s a biosimilar. It’s a similar copy but not an identical copy.”
Poking around the FDA website, I learned that the field got a boost from the Affordable Care Act (aka Obamacare) which created “an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product” – a cost-cutting route to develop alternatives to expensive drugs.
Interesting. And more necessary than ever, since hedge funds and companies of similar ilk have found that they can jack up the price even on drugs that have lost their patent, as long as only one place is making the generic version.
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