Drugs made from living cells, instead of by mixing chemicals, have brought major advances since the late 1990s to the treatment of various cancers, immune system disorders, growth hormone deficiency and eye diseases.
But the drugs, called biologics, often have enormous price tags — up to hundreds of thousands of dollars a year, with crushing out-of-pocket costs for many patients. Part of the problem is that until recently there was no system in place for U.S. regulators to approve cheaper "generic" competition for these treatments because exact copies can't be made.
A 2010 law allows near-copies, known as biosimiliars, after 12 years of market exclusivity for the original. While it's still ironing out some details of its approval process, the Food and Drug Administration has approved three biosimilars over the past year and a half.
But financial relief has been slow to come. Competitors have been kept off the market by regulatory red tape and drawn-out lawsuits between companies developing biosimilars and creators of original biologic drugs, who are desperate to preserve billions in revenue.
So far, only one biosimilar is available in the U.S., a Novartis drug called Zarxio that's a copy of Amgen's Neupogen, for preventing infections in people getting chemotherapy or radiation treatment. By comparison, more than 20 biosimilar versions of seven biologic drugs are available in Europe.
Late last month, FDA approved Novartis's Erelzi, a near-copy of Amgen's Enbrel, but it likely won't launch until after a trial scheduled for 2018. In April, FDA approved Pfizer's Inflectra, a copy of Johnson & Johnson's Remicade, opening the door for it to launch Oct. 3. But Pfizer says only that it is aiming for "sometime in 2016," and J&J's planned appeal of a judge's decision last month invalidating Remicade's key patent could drag on for a year or more.
Remicade and Enbrel, two of the world's top-selling drugs because of their steep prices, treat rheumatoid arthritis, psoriasis, colitis and other immune system disorders.
Dr. Bert Liang, chairman of the Generic Pharmaceutical Association's Biosimilars Council and CEO of drug developer Pfenex Inc., recently spoke with The Associated Press about access to biosimilars. His comments have been edited for clarity and length.
Q: Why is the U.S., where many biologic drugs were developed, so far behind Europe in adopting biosimilars?
A: A large degree of it was (awaiting FDA) guidance and streamlining of the regulatory process. Branded (biologic drugmakers also) are trying to utilize lobbying efforts inside the Beltway, as well as the courts, to delay the introduction of biosimilars. They want to keep their market share.
Q: When will biosimilars finally take off in the U.S.?
A: There's a myriad of biosimilars currently in development, at least 50. In less than three years, you're going to see multiple.
Q: Important questions are unresolved, including whether pharmacists in each state will be able to substitute biosimilars when doctors prescribe original biologic drugs. When will these and other regulatory issues be resolved so launches won't be delayed by months or years?
A: It's going to take at least a couple years to get more clarity around these legal issues.
Q: In Europe, biosimilar drugs have brought savings of roughly 40 percent. What should Americans expect?
A: Zarxio's price is a 15 percent discount. (Nonprofit research group) RAND forecasts discounts of 10 to 50 percent, depending on the number of competitors. Savings up to $40 billion are expected in the U.S. by 2020.
Q: Are there any benefits beyond lower prices?
A: In Europe, there's been direct patient services increases due to the savings. That also frees up resources for other new, effective medicines.
Follow Linda A. Johnson on Twitter at https://twitter.com/lindaj_onpharma.