Patients lose, lawyers win, as AbbVie does deal with Amgen to delay Humira biosim.

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The News:

Amgen Inc. (Thousand Oaks CA) has agreed to delay the US launch of its FDA-approved biosimilar version of AbbVie Inc.’s (North Chicago) Humira (adalimumab) until 2023, under a settlement the companies announced Thursday (September 28, 2017) that ends their patent dispute over the multi-indication chartbuster drug.

Amgen’s Humira copy Amjevita was just the fourth biosimilar authorized for sale in the US when it won FDA approval in September 2016, according to Genetic Engineering and Biotechnology News. Six months later in March 2017, Amgen won European Commission approval for the biosimilar, which will also be marketed in Europe as Amgevita. However, the patent dispute with AbbVie has effectively kept the drug from reaching both markets.

The settlement calls for AbbVie to grant Amgen a nonexclusive license to AbbVie’s Humira-related intellectual property. That license will begin October 16, 2018, in most European countries—and January 31, 2023, in the US.

The companies said they agreed to license periods on a country-by-country basis for worldwide use and sale of Amgen’s Humira biosimilar, though their separate announcements did not furnish details on the dates and nations.

Also undisclosed were precise terms of the settlement, though AbbVie stated that it will receive royalties from Amgen. AbbVie also said that all litigation pending between the parties will be dismissed, and that Amgen has acknowledged the validity of AbbVie’s intellectual property related to Humira.

“Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market,” Scott Foraker, VP and GM of biosimilars at Amgen, said in a statement. “Building on our strong inflammatory disease presence in the US, we are excited to develop our inflammation capabilities in Europe, extending our reach and helping more patients gain access to this important class of therapies.”

Humira is AbbVie’s top-selling drug–and ranked No. 1 among the Top 15 Best-Selling Drugs of 2016 as listed by GEN, with 2016 sales of $16.078 billion, up 14.7% from 2015. During the first half of this year, Humira chalked up $8.834 billion in sales, up 14.3% from January-June 2016.

Steve’s Take:

What a classic example of another Full Employment for Lawyers Act. And don’t think the millions and millions in legal fees aren’t being passed on to us citizens when we become patients, needing medicines.

Steve's Tale: @Abbvie utilizes the Full Employment for Lawyers Act to protect #Humira #patent Click To Tweet

More than a month before the FDA approved Amgen’s Humira biosimilar Amgevita, AbbVie struck a preemptive blow, suing Amgen in US District Court for the District of Delaware. AbbVie accused Amgen of infringing on 61 of more than 100 US patents related to Humira–10 of which were asserted by AbbVie in the lawsuit. (NB: The number 100 is not a typo.)

AbbVie also cited Amgen’s arguments in a separate court case Amgen filed against Novartis AG’s Sandoz unit, seeking to delay its biosimilar Zarxio (filgrastim-sndz), a near-copy of Amgen’s leukocyte growth factor Neupogen (filgrastim): “In seeking to defend its copycat actions here, Amgen is speaking out of both sides of its mouth.” You just know the lawyers came up with that little quip. Meanwhile, Sandoz won its dispute with Amgen in June.

Ka-ching.

A unanimous US Supreme Court reversed a pro-Amgen decision by the US Court of Appeals for the Federal Circuit (CAFC) that forced Sandoz to wait 180 days before it could launch Zarxio. The High Court’s decision handed biosimilar developers a key victory that could generate millions in future sales.

The settlement with AbbVie over Humira is Amgen’s second announcement related to its growing biosimilar effort this week and its third this month. On Tuesday (September 26, 2017), Amgen and China-based Simcere Pharmaceutical Group announced an exclusive agreement to co-develop and commercialize in China four “undisclosed biosimilars in the areas of inflammation and oncology.”

Under their agreement, whose value was not disclosed, Amgen agreed to oversee co-development, marketing approval applications, and manufacturing of the biosimilars–while Simcere agreed to oversee distribution and commercialization in China, where Amgen will have a limited right to co-promote the products.

Ka-ching.

The biosimilars covered by the agreement with Simcere are part of Amgen’s existing biosimilars portfolio, which has grown to 10 programs. That portfolio includes four oncology biosimilars being co-developed with Allergan PLC (Dublin IRL). The companies in July submitted a Biologics License Application seeking FDA approval for one of those four, ABP 980, a biosimilar of Herceptin (trastuzumab).

Another Amgen–Allergan cancer biosimilar on September 14 won the first US approval for a biosimilar cancer treatment following FDA authorization of the companies’ Mvasi (bevacizumab-awwb), a near-copy of Roche Holding AG subsidiary Genentech’s Avastin (bevacizumab).

Ka-ching.

The patent story of Humira has been reported upon widely but is far too complex to easily understand, Seeking Alpha points out. As mentioned, there is a stockpile of patents on Humira, but in saying that it would be protected against biosimilars in the US until at least 2022, AbbVie was relying on “method of treatment” and other “non-composition of matter” patents. These sorts of patents are weaker than “comp-of-matter” patents.

With Amgen and Boehringer-Ingelheim GmbH evaluating what to do with their Humira biosim FDA approvals, don’t forget the others, ranging from the biggest players to tiny Coherus Biosciences Inc. (Redwood City CA), all angling for their own Humira biosims.

Ka-ching.

Bottom Line:

When I saw the headline: “Amgen Acknowledges Validity of AbbVie’s Extensive Intellectual Property Portfolio for HUMIRA,” I had to tip my hat to AbbVie.

With its Humira patents starting to expire last year, and a bevy of competitors hell-bent on crashing the mega-blockbuster’s profit party, Abbvie hasn’t panicked. Unfazed that over 60% of its sales come from demand for Humira, which chalks up sales of over $16 billion per year, AbbVie’s heavy reliance on Humira has had investors nervous about what happens when Humira loses its patent protection.

AbbVie management has believed other patents it’s been granted over the years for manufacturing, method of use, and formulation still give it plenty of patent protection. Recently, AbbVie told investors its patent strategies will be able to fend off Humira biosims until at least 2022. The deal announced with Amgen fortifies that vision.

For the next five years, AbbVie expects Humira to become even more deeply established with doctors and patients. Between price increases and growing prescription volume, AbbVie estimates Humira’s annual revenue will increase to $20 billion, making every month added by patent litigation incredibly valuable.

Ka-ching.

Regardless of when it loses exclusivity on Humira, AbbVie’s management isn’t sitting on its hands, waiting, says Motley Fool. In hopes of offsetting any future risk to Humira’s sales, the company is already investing heavily in acquisitions and research and development.

For example, in 2016, it acquired Pharmacyclics for $21 billion so that it could own 50% of the rights to Imbruvica, a fast-growing drug used to treat patients with chronic lymphocytic leukemia (CLL) and other cancers. Imbruvica’s global sales are already above $2 billion, and growing.

In addition to Imbruvica, AbbVie’s Empliciti, a multiple myeloma drug, won FDA approval in 2015, and Venclexta, a CLL drug, won approval in 2016. The company’s R&D pipeline includes over a dozen cancer drugs in clinical-stage development, including Rova-T, a solid tumor drug it acquired for more than $5 billion in 2016.

Ab­b­Vie, which has now de­layed the lead threat to its top-selling medicine for an­other five years, was shrewd not to gloat this morn­ing, according to John Carroll at Endpoints. Laura Schu­macher, gen­eral coun­sel, simply said:

“We will con­tinue to de­fend our in­tel­lec­tual prop­erty and to rein­vest in fur­ther ad­vance­ments in med­i­cine to bring choices to pa­tients in need.”

All hail the lawyers! Ka-ching. Just remember that jangle is the sound of money going from the payers for branded Humira, including most of us in some manner or another, into the pockets of AbbVie and its legal armada.