FDA panel backs Amgen’s Humira copy, but don’t expect to see it anytime soon

FDA sign

Amgen ($AMGN) took one step closer to approval for its biosimilar of the world’s biggest-selling drug last night, but analysts don’t see it hitting the market this side of 2020 as a bitter patent battle continues.

The FDA advisory panel voted 26-0 that its version of AbbVie’s ($ABBV) Humira (adalimumab), currently known as ABP 501, should be approved along the same lines as the original drug--which includes licenses for rheumatoid arthritis and plaque psoriasis, as well as Crohn's disease and ulcerative colitis (UC).

The panel said the drug was broadly as safe and effective as the drug it was seeking to mimic--although there were some concerns about the Crohn’s and UC license, given that Amgen had not produced trials for these particular indications. In the end, data were extrapolated from the numbers it did have for these conditions.

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This left some panellists uneasy, prompting a request that the FDA should tell biopharma companies to conduct post-market surveillance studies to ensure the product works as expected in those conditions.

The final decision will come from the FDA, and although it does not have to follow the advice of its panel, it typically does. The agency is slated to make a final decision by Sept. 25.  

Humira makes around $14 billion (with $8.4 billion made in the U.S.) a year and, depending on how Amgen decides to price its copy (typically in Europe biosims are around 25% cheaper than the original), it could be set to eventually take a fair chunk of that away.

So, champagne corks popping at Amgen? Not quite, as even if, as expected, it gains full approval for all indications this year, it will likely not be launching its drug until 2022 if AbbVie has anything to do with it.

That’s because the two have locked horns in an increasingly bitter patent war, as AbbVie believes it has another 6 years of legal protection before anyone can release a biosimilar version. 

In May, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board said it would review a challenge by biosim maker Coherus on Humira’s patent. A decision is expected around next May. Back in January, PTAB did decline to review a patent on Humira by Amgen. 

Analysts at Jefferies note that these ongoing legal hurdles may keep ABP 501 off market “well beyond” its expected approval date at the end of September. It also noted that to date, Amgen “hasn't provided a launch timing or legal strategy for ABP 501.”

Jefferies does not see its biosimilar products as adding too much to its revenue projections for the U.S. company, however, and thus said a delay will not hit the pharma’s sales stream too hard.

There are a host of other Big Pharmas lining up to also cut in on AbbVie's major earner, and may watch what Amgen does this year with an especial interest.

This includes Merck ($MRK), working with Samsung Bioepis, plus Novartis ($NVS) and partners Baxalta ($BXLT) and Momenta Pharmaceuticals ($MNTA), among others.

Copied versions of the treatment are in fact already on the market--in 2014, patients in India were the first to receive a Humira biosimilar launched by the Indian company Zydus Cadila.

But in a reverse of fortune, Amgen is in fact today playing the role of AbbVie as the FDA panel turns its attentions to a biosimilar version of its blockbuster drug Enbrel (etanercept), which is indicated for rheumatoid arthritis and other chronic autoimmune conditions.

Novartis is seeking an approval for its Enbrel copy GP2015, which FDA staffers have already said in documents posted on the agency’s site this week is “highly similar” to its reference product, and the 5 licenses Enbrel has. The panel will meet today to discuss whether it too should recommend approval.

But guess what? In a familiar sounding scenario, Amgen is suing Novartis’ generic and biosimilar unit Sandoz on the grounds that its biosimilar infringes several of Enbrel's patents, so any launch could also be delayed.

At least 11 other biosimilar versions of Enbrel are currently in the development pipeline, while European regulators have already cleared Samsung Bioepis’ version and are also currently reviewing Sandoz’ drug.

And Amgen was in fact the first to succumb to biological copies in the U.S. when, just over a year ago, the FDA approved its first biosim in the form of Zarxio (filgrastim-sndz) from Sandoz--a biosimilar of Amgen's chemotherapy side effects drug Neupogen (filgrastim).

Beyond its version of Humira, Amgen is currently working with Allergan ($AGN) on biosimilars of Eli Lilly's ($LLY) Erbitux and Roche's ($RHHBY) Avastin, Herceptin and Rituxan. On its own, the company is developing a version of ​Johnson & Johnson's ($JNJ) Remicade and three more undisclosed programs.

Citigroup analysts estimate that originator biologics will lose about $110 billion in sales to copycats by 2025.

- check out Amgen’s release

Related Articles:
Amgen's Humira biosimilar nears FDA nod, but legal hurdles remain
FDA publishes more biosimilar labeling advice after pharma voices its concerns
Merck launches late-stage trials for Humira biosimilar

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