Genentech works against federal health care edict

NEW YORK — One part of the big health care overhaul that is expected to save billions of dollars is the introduction of generic versions of biotechnology drugs that now can cost a patient tens of thousands or even hundreds of thousands of dollars a year.

The complex drugs, made in living cells instead of chemical factories, account for a growing share of spending on medicines. They include some of the world’s best-selling drugs, like the rheumatoid arthritis and psoriasis drugs Humira and Enbrel and the cancer treatments Herceptin, Avastin and Rituxan.

But the two biggest biotechnology companies, Amgen and Genentech – which has a plant in Vacaville – are mounting an intensive lobbying effort in state legislatures that could blunt the new competition to their products and reduce the savings anticipated in the federal law.

The companies are proposing bills that would restrict the ability of pharmacists to substitute a generic version of a biologic drug for the brand name product. The Virginia House of Delegates passed one such bill last week.

The companies and other proponents say such measures are needed to protect patient safety because the generic versions of biotech drugs are not identical to the original products. For that reason, they are usually called biosimilars rather than generics.

Generic drug companies and insurers are moving to oppose or amend the state bills, which they characterize as pre-emptive moves to deter the use of biosimilars, even before any get to market.

”All of these things are put in there for a chilling effect on these biosimilars,” said Brynna M. Clark, director of state affairs for the Generic Pharmaceutical Association. The restrictions, she said, “don’t sound too onerous but undermine confidence in these drugs and are burdensome.”

The trench fighting at the state level is just the latest phase in a continuing battle over the ground rules for adding competition to the biotechnology drug market as called for in the Patient Protection and Affordable Care Act of 2010.

Biosimilars are unlikely to be available in the United States for at least two more years, though they have been on the market in Europe for several years. And the regulatory uncertainty appears to be diminishing enthusiasm among some companies for developing such drugs.

“We’re still dealing with chaos,” said Craig A. Wheeler, the chief executive of Momenta Pharmaceuticals, which is developing biosimilars. “This is a pathway that neither industry nor the FDA knows how to use.”