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Biologic Market Slips as Biosimilars Come to the Fore

During the health care debate, this website focused on the biologics provisions in the law. Because of the influence of biotechnology companies, lawmakers pushed for an exemption of 12 years for the expensive drugs, during which time no generics could enter the market. In the final negotiations that got lowered to 10 years. In some of the deficit reduction packages, the White House has proposed a further drop to seven years. And now one biotech firm is preparing for that eventuality.

The world’s biggest biotech firm and a leading generic drugmaker said Monday they are teaming up to produce “biosimilar” versions of several biologic medicines for cancer, an important partnership in a future niche that many hope will lower costs of some of the most expensive medicines.

Amgen Inc., a maker of biologic drugs for cancer, kidney disease and rheumatoid arthritis, said it’s partnering with Watson Pharmaceuticals Inc., which makes both generic medicines and branded drugs for women’s health and for urologic conditions.

Together, they plan to develop and then sell what are called biosimilars or follow-on biologics, medicines similar to innovative biologic drugs but not identical in the way generic drugs are copies of brand-name pills.

Biosimilars are not generics, as said above. And they don’t carry the same savings as generics. But they do chip away at the market share for these improbably expensive drugs, which cost up to $100,000. The FDA is poised to approve these biosimilars for domestic use.

I have seen over the past couple years a degradation in the ability for the pharmaceutical industry to get every single thing it wants. This hasn’t fully manifested itself yet, but the biosimilar move shows they are preparing for that day, and making plans to try and hold onto their market share in the aftermath.

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David Dayen

David Dayen

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