It didn’t take long for AbbVie to strike out against Amgen’s Humira biosimilar. Less than a month after an FDA panel gave the Humira copy a hearty thumbs-up, AbbVie has sued for patent infringement--and it's trying to use Amgen's own biosim defense against it.
The lawsuit claims that Amgen’s ($AMGN) biosim steps on 10 AbbVie ($ABBV) patents and asks the court to block the launch if and when the FDA issues an approval.
Amgen was destined to face a court challenge, of course. The U.S. biosimilars legislation was designed to allow for patent litigation, after all. And Amgen itself has benefited from those provisions. The California biotech stalled the first FDA approved biosim, a Novartis ($NVS) copy of its Neupogen drug, for 6 months after its approval last spring.
Plus, AbbVie has been aggressively shoring up its Humira intellectual property and promising to defend the megablockbuster from biosimilar competition. Though analysts see a Humira copy hitting the market by 2018, the Illinois-based drugmaker says it can hold off biosims until 2022.
AbbVie certainly hopes so: Humira accounts for almost two-thirds of the company’s revenue.
Though AbbVie has been scrambling to beef up its drug portfolio and build out its pipeline, none of its newer meds came close to Humira’s $14 billion in 2015. And the drug continues to account for the lion’s share of AbbVie’s sales growth, with a 17% increase in the second quarter to $4.15 billion. Analysts who buy into AbbVie's patent defense figure the drug can remain the world's best-selling med to 2020, with $16 billion-plus in sales that year.
CEO Richard Gonzalez predicts that the blood cancer drug Imbruvica, which it shares with Johnson & Johnson ($JNJ), can eventually bring in $7 billion in annual sales for AbbVie. He bet $21 billion on buying Pharmacyclics for that very reason, and the drug has been racking up new data and approvals since. But even under a best-case Imbruvica scenario, if Humira falls victim to biosims before then, AbbVie faces some lean years--unless it can pull off more defensive M&A.
Citi analyst Andrew Baum, for one, has forecast a quick drop-off for Humira after biosims appear--an event he expects far sooner than AbbVie does. After peaking at $16 billion in sales next year, the drug will take a hit in 2018 and decline after that to $6 billion in 2022.
All of which explains why AbbVie is not only suing to defend those 10 Humira patents, but threatening to follow up with more court challenges. In its complaint, AbbVie claims that Amgen’s product infringes 51 more patents as well. Amgen’s “blatant infringement” should be stopped, AbbVie says.
Among patents AbbVie cites are those that cover Humira’s complex manufacturing process and its subcutaneous formulation. “There is no question that Amgen infringes AbbVie’s patents; it does not even dispute this fact with respect to many of AbbVie’s patents,” the complaint contends, going on to offer Amgen’s failed inter partes review challenge at the U.S. Patent and Trademark Office as evidence backing up Humira’s IP.
In an ironic twist, the AbbVie lawsuit aims to capitalize on Amgen’s own biosimilar defense. In delaying Novartis’ Neupogen copy, Zarxio, Amgen claimed that biosimilars “[piggyback] on the fruits” of “innovators’ trailblazing efforts." That shows that Amgen is “speaking out of both sides of its mouth” on biosimilars. “While Amgen may hope to profit by straddling the fence, it should be held to the positions it has taken in procuring its own patents and litigating those patents against biosimilars,” the lawsuit claims.
Amgen isn’t the only company looking to grab a piece of the Humira pie. Novartis; Merck ($MRK) and its partner Samsung Bioepis; and partners Baxalta and Momenta Pharmaceuticals ($MNTA) all have their own Humira biosims in development. With the FDA panel’s backing, Amgen’s biosim could be approved this fall.
Meanwhile, Amgen is working with Allergan ($AGN) on biosimilars of Eli Lilly's ($LLY) Erbitux and Roche's ($RHHBY) Avastin, Herceptin and Rituxan. On its own, the company is also developing a version of Merck’s Remicade.
- see AbbVie’s lawsuit
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