BioPharm Executive: Not All States are Biosimilar

Published: Aug 28, 2013

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August 28, 2013

Not All States are Biosimilar

I recently bought a lawn mower that was labeled "not for sale in California." I have a plastic ruler that "contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm." If anyone from California enters my house, I think I'm supposed to warn them that there is a microwave on the premises.

The most populous state has a way of cleaving its own path, and making rules that, for better or worse, shape the way things are done in the rest of the country. That's why the state is being closely watched as the country continues to grapple with the anticipated launch of biosimilars.

The issue is theoretical for now. The "pathway" for biosimilars laid out in the Affordable Care Act remains untrodden and only dimly charted, and it will likely be a couple of years before biologic knock-offs are launched. Many issues remain undetermined--will biosimilars go by the same generic name as the innovator brands, thereby paving the way for substitution? What exactly is the higher standard FDA will require for interchangeability rather than mere similarity?

All this year, the Alliance for Safe Biologic Medicines, a lobbying group led by Amgen and Genentech and backed by the Biotechnology Industry Organization (BIO)--has been waging a state-by-state campaign to get laws passed that would restrict how biosimilars are prescribed and used.

So far, they've met with nearly unmitigated failure. Thirteen states have so far rejected the idea of legislating restrictions outright. Four have passed laws, but three of them--Virginia, Utah, and Oregon--have included sunset provisions that will likely render the laws moot before they have any impact on biosimilar usage. The only clear victory the biotech industry can claim thus far is North Dakota.

But California could change all that. A few days ago, a bill that would place certain restrictions on biosimilar prescribing was overwhelming passed by a legislative committee of the State Assembly, after already clearing the Senate. California is of course home to Amgen, Genentech, and many other biotechs. While it's hard to say how significant a factor that is, the state stands poised to do something many have refused, while critics are warning that it could stifle adoption of biosimilars and cost patients and insurers hundreds of millions of dollars in needless extra expense.

But how likely is that? While this has been the subject of a lot of legislative effort, not to mention millions of dollars spent in lobbying, it's far from clear that these laws will actually make a huge difference.

For one thing, they are aimed at how pharmacists dispense biologics--which they seldom do, since most of these drugs are administered in a hospital under a physician's direct supervision. The laws also only apply only to any biosimilars deemed interchangeable by FDA--the biotech and generics industries are generally in agreement that there shouldn't be automatic substitution of merely similar drugs. Such interchangeable drugs a) don't exist yet; and b) may actually require some sort of state law to govern dispensing if they are to be used at all.

Then there's the fact that the line between biotech and generic companies is getting blurred. Innovator companies are often leading the charge to create biosimilars. They have a strong interest in protecting their own brand franchises, of course, but they also intend to benefit from expiring patents on other leading drugs. It has made for some strange bedfellows, like generic company Actavis (the former Watson Pharmaceuticals) lobbying in favor of the California bill sponsored by Amgen and Genentech.

Indeed, the director of state affairs for the Generic Pharmaceutical Association, which opposes such legislation, acknowledged in the New York Times back in January that the bills "don't sound too onerous," but argued more vaguely that they "undermine confidence in these drugs and are burdensome."

Certainly the biotech industry would like more control over when and how biosimilars are dispensed. But these laws just don't go very far in that direction, particularly since the more burdensome aspects have been stripped out. (North Dakota, for instance, removed a provision that would have required patients to give their permission for a substitution.)

While I'm not so naive as to think that the Alliance for Safe Biologic Medicines is thinking of nothing beyond patient safety, there is more than a grain of truth to their basic argument that biologics are not like conventional small molecules and should be governed by different rules. Some of the sillier provisions aside, the basic thrust of these proposed laws is to stop substitution from being automatic--as it is under the policies of many insurers and states--and make it a deliberate decision. That's not such a terrible idea, and with the right policies in place from insurers (which will have a strong incentive to encourage substitution wherever possible), it shouldn't significantly slow the adoption of biosimilars.

It remains to be see what California will do. Despite passage in the house, the bill faces an uphill battle--it's been opposed by the California Public Employees’ Retirement System (Calpers), which manages the largest public pension fund in the country and has a lot of political clout. But if it does pass, California may again become an outlier that ends up influencing the rest of us.

-Karl Thiel

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