Christie signs measure to allow sale of biosimilar drugs
New Jersey cancer patients will be able to receive the first biosimilar drug available in the United States after Gov. Chris Christie signed legislation this week legalizing the use of the discounted versions of some of the world's most expensive drugs.
U.S. regulators approved Novartis AG's Zarxio in September, which is a generic biosimilar version of Amgen Inc.'s Neupogen, which boosts white blood cell production to prevent infections in certain cancer and other patients. Biologics are injected or infused medicines for very serious conditions such as cancer and immune system disorders. They can cost $100,000 or more annually.
Unlike traditional pills made by mixing chemicals, biologic drugs are made from proteins grown in living cells, nourished in nutrient broths inside sterile bioreactor tanks. The process can take weeks and requires precise control of temperature, oxygen level and other conditions. The proteins are then filtered out of the cells, purified, mixed with a sterile injectable solution and put into vials or syringes. Biosimilars are made the same way.
"This legislation will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments," said Jim Greenwood, president and CEO of BioNJ.
The measure signed by Christie on Monday gives pharmacists the power to fill prescriptions for the drugs, and drugmakers the power to sell them in the state once they're approved by the FDA. Eleven other states and Puerto Rico have enacted the new rules this year.
Those who make biologic drugs, including Merck & Co., also will eventually face biosimilar competition to their own biologic drugs.
"The FDA has created a safe pathway to make alternative biological medicines more readily available on the market," said Assemblywoman Pamela Lampitt, who co-sponsored the legislation. "If there is a more cost-effective option to treat and cure various illnesses, then by all means we should be helping patients pursue it."
The biosimilar drugs have been on sale for years in other countries. Biologic drugs include vaccines and other complex medicines, including ones that incorporate antibodies to target where they're needed. Last year, six of the 10 bestselling medicines globally were biologics, with about $49 billion in combined sales.
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