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by outworlder
1224 days ago
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> Is California just going to ignore these intellectual property laws? How will the state not be liable for damages when individuals are? Insulin can be made without breaking patents. Unless you specifically require something branded as Lantus®, for example(which is in no small part due to publications funded by pharmaceutical companies themselves, but also some 'marketing' straight to doctors). There are other longer lasting insulin formulations that can be made. There are hurdles if you take that route (as described in the article). Many are financial. One is regulatory (biosimilars). |
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> Other federal regulations have added to the challenge. The FDA began to treat insulin as a biologic drug in 2020 — meaning it is made with living materials instead of combining chemicals like conventional pharmaceuticals — which comes with a different set of standards for generic versions, which are known as biosimilars, as well as manufacturing challenges given the precise conditions these products must be made in. Biosimilars can cost up to $250 million to produce and take up to eight years to bring to the market, versus a one-year investment of as little as $1 million for conventional generics. And unless the FDA recognizes a new generic insulin as interchangeable with the products already on the market, health insurers might not want to cover it and doctors may not be willing to prescribe it.
Seems like the barriers for a state entity are exactly the same as the barriers for private generic drug manufacturers, and the state could easily just stop erecting these barriers.