In statehouses around the country, some of the nation’s biggest biotechnology companies are lobbying intensively to limit generic competition to their blockbuster drugs, potentially cutting into the billions of dollars in savings on drug costs contemplated in the federal health care overhaul law.
The complex drugs, made in living cells instead of chemical factories, account for roughly one-quarter of the nation’s $320 billion in spending on drugs, according to IMS Health. And that percentage is growing.
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. The drugs now cost patients — or their insurers — tens or even hundreds of thousands of dollars a year.
Two companies, Amgen and Genentech, are proposing bills that would restrict the ability of pharmacists to substitute generic versions of biological drugs for brand name products. Bills have been introduced in at least eight states since the new legislative sessions began this month. Others are pending.
The Virginia House of Delegates already passed one such bill last week, by a 91-to-6 vote.
The companies and other proponents say such measures are needed to protect patient safety because the generic versions of biological drugs are not identical to the originals. For that reason, they are usually called biosimilars rather than generics.
Generic drug companies and insurers are taking their own steps 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.
The trench fighting at the state level is the latest phase in a battle over the rules for adding competition to the biotechnology drug market as called for in the Patient Protection and Affordable Care Act of 2010.
“We’re still dealing with chaos,” said Craig 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.”