The year 2013 began with the promise of a state-by-state, coast-to-coast battle between the makers of brand-name medications derived from living organisms — known as biologics — and those who to make and sell copies of those drugs.

The battle has turned into a rout, at least for now. In state after state, the brand-name makers — led by the pharmaceutical giants Amgen and Genentech — have been unable to convince state legislatures to require pharmacists to notify doctors (and sometimes patients) when they substitute generics for brand-name biologic drugs. Manufacturers of copies fiercely opposed such a requirement, which they said would put them at a competitive disadvantage.

Notification measures died in Arizona, Arkansas, Colorado, Indiana, Illinois, Maryland, Mississippi, Nevada, Texas and Washington.

Oregon, Utah and Virginia all adopted notification requirements, but with sunsetting provisions that will take effect before any of the knock-offs reach the market. Only one state, North Dakota, passed the measure the brand-name manufacturers sought.

“State legislators accepted that there was absolutely no need to push this type of legislation” said Brynna Clark, senior director of state affairs for the Generic Pharmaceutical Association, which took the lead in organizing the effort against notification requirements. “Nobody’s hair was on fire.”

Measures are still alive in California, where the prospects for passage look bright, and in Pennsylvania and Massachusetts.

Two Years Away

Most believe it will be at least two years before any copies of biologics receive approval from the Food and Drug Administration (FDA). But the skirmishes in 18 states this year give a sense of the high stakes involved.

Biologics already account for roughly a quarter of the $320 billion spent annually on medications in the U.S., according to IMS Health, and biologic medicines are expected to command ever larger portions of the prescription drug marketplace. The Congressional Budget Office has estimated that substituting biologic doppelgangers for brand names would reduce federal Medicaid and Medicare spending by $25 billion over 10 years.  The CBO estimates that total federal spending on prescription drugs during the same period will total $500 billion.

The Affordable Care Act calls for an abbreviated approval process for the biologic copies, as a means to promote competition and reduce costs. While the federal government will determine whether particular biosimilars are interchangeable with the originals, it will be up to the states to determine the exact policies regarding substitutions.

Companies that make the copies say their products should be treated no differently than generic chemical drugs. By state law, pharmacists can (and in some cases, must) substitute cheaper generics for brand-name medications once the original patent has expired, unless otherwise directed by the doctor or, in some states, the patient.

Complex Substances

But, there are big differences between copying chemical drugs and copying biologic drugs.

Until the 1970s, virtually all manufactured medicines were derived from chemicals. They are sometimes called “small molecule” drugs because they are composed of relatively few atoms and have stable, well-defined chemical structures, making it relatively easy to produce exact duplicates.