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The reason: a appalling bank of patents congenital up by Humira-maker AbbVie Inc., that prevents the developers of “biosimilar” versions ablution their articles in the U.S.

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Biosimilars are near-copies of biologic drugs, such as Humira, that are fabricated from active beef in a action that resembles brewing. They are akin to all-encompassing copies of acceptable pill-form medicines.

The capital U.S. apparent for Humira — a biologic which is acclimated to amusement diseases from rheumatoid arthritis to gut disorders — asleep in 2016. But AbbVie has acquired added than 100 added U.S. patents, a cardinal acknowledged experts alarm as aberrant for a distinct drug. The shelf lives of those patents extend into the 2020s and 2030s.

AbbVie cited these newer patents, which awning accomplishment processes and added aspects of the drug, in lawsuits to block the two biosimilar versions accustomed in the U.S. Added companies say that has beat them from bringing biosimilars to bazaar quickly.

Critics, including assembly and industry officials, say AbbVie has created a “patent thicket” that abuses the U.S. apparent arrangement in adjustment to bottle its profits.

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AbbVie says it is attention investments it fabricated developing an avant-garde drug. “There’s annihilation about our bookish acreage about Humira, or the licensing agreements we’ve done … that’s annihilation aing to gaming the system,” AbbVie Arch Controlling Richard Gonzalez said on a appointment alarm with analysts in July.

Biologic drugs are some of the costliest in the world, and the availability of lower-cost versions as patents expire promises big savings. Humira abandoned has added than $18 billion in all-around sales.

In Europe, over 20 biosimilar drugs accept gone on auction aback the aboriginal approval in 2006, in what industry assemblage say is a added affable acknowledged ambiance to claiming patents. In the U.S., area the FDA has accustomed 12 biosimilar drugs aback 2015, alone bristles are accessible for sale.

“Europe has a abundant added able-bodied and able and time-tested agency to claiming the authority of patents,” said Robert Cerwinski, a New York-based bookish acreage advocate specializing in pharmaceuticals at Goodwin Procter LLC. “So the companies were able to claiming AbbVie patents in the alleged apparent bracken beforehand and added finer than in the U.S.”

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AbbVie said in a account that it welcomes the addition of biosimilars in Europe but patients who are abiding on their absolute drugs shouldn’t be switched to addition artefact for nonmedical reasons.

Amgen Inc. and Novartis AG plan to alpha affairs their biosimilar versions of Humira — Amgevita and Hyrimoz appropriately — on Tuesday as anon as the European apparent expires. Samsung Bioepis Ltd. and Mylan NV are accepted to alpha affairs their versions anon after.

Companies haven’t appear appraisement for the Humira biosimilars, but they’re accepted to advertise at a 10% to 25% abatement to Humira’s $10,000 to $22,000 anniversary amount tag in Europe’s better biologic markets, according to Alexandra Annis, an analyst at health-care-market intelligence close GlobalData.

Aback Humira generates an estimated $4 billion in anniversary sales in Europe, its second-biggest bazaar afterwards the U.S., the discounted prices should crop hundreds of millions of dollars in anniversary accumulation for the continent’s bloom systems.

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England’s National Bloom Service, which currently spends added than GBP400 actor ($526 million) a year on Humira, says it hopes to save at atomic GBP150 actor a year by 2021 by switching to biosimilars.

But in the U.S., added patents accept pushed biosimilar developers to adjournment bringing their articles to bazaar until the aing decade.

Amgen and Boehringer Ingelheim GmbH developed the two Humira biosimilars accustomed in U.S., but they haven’t so far gone on sale. Amgen acclimatized action with AbbVie and agreed to delay until 2023 to barrage its version. Boehringer Ingelheim says it affairs to acquaint a biosimilar Humira in the U.S. afore 2023, but it hasn’t defined a date while it defends itself adjoin a patent-infringement accusation brought by AbbVie.

At atomic three added AbbVie rivals- — Samsung Bioepis, Mylan and Novartis AG — accept agreed in acknowledged settlements with AbbVie not to advertise their advancing biosimilars in the U.S. until 2023.

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For now, AbbVie has a U.S. cartel on a biologic whose amount has risen to added than $60,000 annually for some patients in the 15 years aback it launched, and which racked up added than $12 billion in U.S. sales aftermost year.

Slow approval of biosimilars, as able-bodied as bound uptake already such drugs do go on auction in the U.S., is costing the American health-care arrangement an estimated $15 billion-$18 billion a year in absent savings, according to Gary Stibel, architect and CEO of the New England Consulting Group.

A decade ago, the acknowledged non-biologic drugs in the U.S. had an boilerplate of bristles patents each, according to Lisa Larrimore Ouellette, a law assistant at Stanford University. Now, the 12 top-selling drugs in the U.S., abounding of which are biologics, accept an boilerplate of 71 patents per drug, according to a contempo abstraction from I-MAK, a accumulation that files acknowledged challenges adjoin the authority of brand-name biologic patents.

Some adopted and appointed admiral accept aloft questions about patents as impediments.

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FDA Commissioner Scott Gottlieb in July criticized “patent thickets” for brand-name biologic drugs “that are absolutely advised to avert the access of accustomed biosimilars,” adage they’ve baffled competition. He didn’t analyze companies he believes are accomplishing so.

AbbVie in accurate has admiring aciculate criticism over its patenting activities. In December 2017, Sen. Susan Collins (R-Maine), said AbbVie’s patents accept “blocked competitors from advancing to the market” and alleged for means to adverse such practices.

“It’s billions of dollars that this costs the U.S. health-care system,” said Dennis Lanfear, arch controlling of Coherus Biosciences, which has pushed aback its planned U.S. barrage date for a Humira biosimilar to 2022 from 2018 because of AbbVie’s patents. “The bazaar would be served if there was added competition.”

Write to Abate Loftus at [email protected] and Denise Roland at [email protected]

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(END) Dow Jones Newswires

October 16, 2018 07:14 ET (11:14 GMT)

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