Rerun: A better idea than biogenerics

The Health Business Blog is on summer vacation until Labor Day, and will be re-running some classic posts from now till then.

This item originally ran on November 27, 2006. If you’d like to leave a comment please do so on the original post.

Generics are a bright spot in the world of health care costs. Safe, efficacious generics are available in an increasing number of key therapeutic classes. Producer level prices have been low for years. Thanks to Wal-Mart those low prices are now making their way through to patients. With Democrats in control of Congress, barriers to the introduction of generics are likely to fade.

But there’s a large and growing exception to the generic trend: biotech. Biotech drugs are an expensive and rapidly growing component of drug spending and the trend is likely to continue.
It’s hard if not impossible to make exact copies of biotech drugs and there’s no clear regulatory framework for their approval. According to the Wall Street Journal (Democrats’ Rx? Generics):

Some biotech officials argue that generics makers will need to redo all the studies performed by the original manufacturer, in order to guarantee their copycat products are effective and safe for patients. That would likely eliminate much, or all, of the price advantage offered by the generics rivals. “There is no way to characterize a biological,” says James Greenwood, a former congressman who heads the Biotechnology Industry Organization, a trade group.

You should take the self-interested statements above with a grain of salt. Still it probably doesn’t make sense to apply the same generic model to the biotech industry, even though it’s worked well for traditional drugs. Instead I suggest the following:

  • Allow biotech drugs to be approved and marketed as they are now, without price regulation
  • After patent expiration or after a certain number of years on the market, regulate price. The price could be based on cost of goods, a percent of the previous selling price, or some other mechanism

This would avoid the costs and risks of biogeneric development and regulatory approval while delivering the benefits of lower costs to payers. The original maker of the product should be happy too. Although their price will be lower than it is today, they won’t have to share the market with generic players or spend money blocking the entry of new players. They will still enjoy a substantial period of high margin sales as they do today. It just won’t go on forever.

When, at some point in the future, science improves to the point where truly identical biogenerics can be developed, these rules could be revisited.

If you’d like to leave a comment please do so on the original post.

August 25, 2010