Patent for J&J's Remicade invalidated, cheaper version looms

FILE - In this July 30, 2013, file photo, people walk along a corridor at the headquarters of Johnson & Johnson in New Brunswick, N.J. A cheaper version of J&J's top-selling drug, the rheumatoid arthritis treatment Remicade, could be available in the U.S. two years early after a federal judge ruled a key patent on the drug invalid. J&J said Wednesday, Aug. 17, 2016, it plans to appeal the ruling. (AP Photo/Mel Evans, File)

TRENTON, N.J. — A cheaper version of Johnson & Johnson's top-selling drug, the pricey rheumatoid arthritis treatment Remicade, could be available in the U.S. two years early after a federal judge ruled that a key patent on the drug is invalid.

J&J, based in New Brunswick, New Jersey, said Wednesday it plans to appeal a summary judgment issued by the District of Massachusetts federal court in a high-stakes patent fight with rival drugmaker Pfizer Inc. The appeal process could take a year or more, J&J said.

Pfizer likely will make the somewhat-risky move of launching its competing version, called Inflectra, within a few months.

That could bring patients and insurers savings analysts have estimated at 15 to 30 percent. Remicade is approved for treating chronic conditions in which the immune system goes haywire and attacks part of the body, including rheumatoid arthritis, ulcerative colitis, psoriasis and Crohn's disease.

The drug costs roughly $1,600 a month or more without insurance, depending on the condition being treated, the patient's weight and whether they have just started on Remicade or are on continuing therapy. Pfizer hasn't announced a price for Inflectra.

Remicade is an injected biologic drug, "manufactured" in living cells rather than by mixing chemicals. Its just-invalidated patent would have blocked so-called "biosimilars" — nearly identical copies of biologic drugs — until September 2018.

Remicade has been J&J's biggest revenue generator for several years, pulling in $6.6 billion in 2015, two-thirds of that from U.S. sales. New York-based Pfizer is seeking a big slice of that pie after having won U.S. Food and Drug Administration approval in early April for Inflectra — only the second biosimilar drug approved in the U.S.

The approval allows sales of Inflectra beginning Oct. 3. It would be made by Pfizer's Hospira unit, bought last year to boost Pfizer to the top of the nascent field of biosimilars.

Hospira specializes in making biologic medicines and other sterile injectable medicines. While only one biologic has reached the U.S. market, more are on the horizon and several have been on sale for a few years in Europe. Government health programs there negotiate drug prices and press for cheaper versions.

"We are committed to bringing biosimilars to patients in the U.S. as quickly as possible, and are continuing with the preparation of our launch plans for Inflectra for 2016," Pfizer said in a statement Wednesday. A spokeswoman could not provide a more-specific time frame.

But if J&J wins its planned appeal of the federal court ruling and Remicade's patent is upheld, Pfizer could be on the hook for paying J&J big financial damages.

___

Follow Linda A. Johnson on Twitter at https://twitter.com/lindaj_onpharma.

You may also interested in

NYC landmarks Art Deco interiors of Waldorf Astoria

Mar 7, 2017

New York City has landmarked historic interiors throughout the Waldorf Astoria to preserve them before the hotel's Chinese owners start a yearslong renovation

Honda reports 19 percent rise in profit on sales, cost cuts

Aug 1, 2017

Japanese automaker Honda Motor Co. is reporting a nearly 19 percent improvement in fiscal first quarter profit on better sales and cost cuts

WikiLeaks: CIA has targeted everyday gadgets for snooping

Mar 8, 2017

Documents released by WikiLeaks allege a CIA surveillance program that targets everyday gadgets ranging from smart TVs to smartphones to cars

People also read these

NYC landmarks Art Deco interiors of Waldorf Astoria

Mar 7, 2017

New York City has landmarked historic interiors throughout the Waldorf Astoria to preserve them before the hotel's Chinese owners start a yearslong renovation

Honda reports 19 percent rise in profit on sales, cost cuts

Aug 1, 2017

Japanese automaker Honda Motor Co. is reporting a nearly 19 percent improvement in fiscal first quarter profit on better sales and cost cuts

WikiLeaks: CIA has targeted everyday gadgets for snooping

Mar 8, 2017

Documents released by WikiLeaks allege a CIA surveillance program that targets everyday gadgets ranging from smart TVs to smartphones to cars

Weather, 20 December
Houston Weather
+7

High: +11° Low: -2°

Humidity: 83%

Wind: NNE - 7 KPH

Canberra Weather
+27

High: +27° Low: +17°

Humidity: 87%

Wind: W - 20 KPH

Roissy-en-France Weather
+6

High: +6° Low: -5°

Humidity: 87%

Wind: ENE - 7 KPH

Florence Weather
+9

High: +9° Low: +6°

Humidity: 97%

Wind: ENE - 17 KPH

Parga Weather
+7

High: +16° Low: +4°

Humidity: 100%

Wind: SE - 25 KPH