Viewpoints: Will Humira biosimilars launch in Europe this year?

(Ref: ViewPoints Desk)

The biosimilars market continues to generate headlines, albeit for the impact these products are having on branded biologics. Most recently, Roche reported a 25-percent decline in European MabThera sales during the fourth quarter of 2017, a region where biosimilar rituximab competition is in full swing with the launch of Celltrion's Truxima and Rixathon from Novartis' Sandoz unit (see ViewPoints: Does Roche's biosimilar math add up?).

Roche will soon have more on its plate, with Herceptin biosimilars expected to hit European pharmacy shelves sometime in late 2018 or early 2019. Samsung Bioepis' Ontruzant is already approved, and a number of other Herceptin biosimilars are under review at the European Medicines Agency.

It's the fortunes of AbbVie, however, which seem to be garnering the most interest ahead of a potential European debut for Humira biosimilars in the fourth quarter of 2018. Humira generated global sales of $18.4 billion in 2017, equal to 65 percent of AbbVie's total revenues.

What happened?

AbbVie's share price increased by 54 percent in 2017, ostensibly driven by an agreement it reached with Amgen in August last year that delays the latter from launching its Humira biosimilar, Amjevita, in the US market until 2023 (see ViewPoints: AbbVie's biosimilar settlement with Amgen could be decisive).

In Europe, however, Amgevita (the European brand name for Amgen's Humira biosimilar) is expected to reach the market in October 2018, along with as many as three to four other Humira biosimilars, including Boehringer Ingelheim's Cyltezo, Samsung Bioepis/Biogen's Imraldi and Humira biosimilars from Fujifilm Kyowa Kirin Biologics (FKB), Sandoz and Pfizer.

A key question remains, however; will Humira biosimilars actually be allowed to launch in Europe in October 2018? Understanding the legal issues that surround this can provide some clarity.

The backstory

In March 2017 the UK High Court of Justice ruled in favour of FKB and Samsung Bioepis in patent litigation proceedings brought against AbbVie in respect of the validity of certain Humira dosing regimens for rheumatoid arthritis, psoriasis and psoriatic arthritis. FKB and Samsung brought the action in relation to FKB327 and SB5 (Imraldi), respectively, both of which are Humira biosimilars.

What the High Court of Justice provided to the two companies in question was an 'Arrow Declaration,' which refers to a declaration that a particular product or process that may be commercialised falls within the state of the art at the time the patent owner's rights were first filed. If so, any patent rights covering such a product or process cannot be valid because patents cannot cover what was already known or obvious from the state of the art.

In an emailed statement soon after the ruling was announced, Dominic Adair – partner at law firm, Bristows – told FirstWord that "this is the first time that the Patents Court has exercised its discretion to grant an Arrow declaration. The result will be welcomed by those parties looking to launch biosimilar products in the UK as it will negate the risk of pending patent applications having the same subject matter as the declaration proceeding to grant shortly before or after a product has been launched and the resultant injunction/damages risk."

The key question(s)

With FKB and Samsung Bioepis successful in clearing the way of dosage regimen patents for Humira in the UK, two key questions must now be asked. Firstly, can other Humira biosimilar developers ride on the coat tails of this judgement, or is it limited to FKB and Samsung only? Secondly, what's the likelihood of companies trying to use the judgement in other European markets?

In response to the first question, Adair says that things are far from clear. "No-one knows for sure, but it's more than likely. If another Humira biosimilar came along with the same label and wanted to rely on the judgment, the court would be very sympathetic to their cause if AbbVie refused to acknowledge that they were free to launch," he noted. Adair continued by saying that "the declaration was given to FKB on the basis that their biosimilar product could not be caught by the Humira dosage regimen patents in suit in that case if the patents were also to be valid. If another Humira biosimilar with the same label – and hence the same dosage regimen – came along it would be very hard to stop."

In order to prevent other companies from using the ruling, it would seem that AbbVie would have to argue either that the biosimilar's dosage regimen was in some way different, or that the biosimilar was not similar enough. Adair suggests that "if AbbVie refused to acknowledge the new competitor's freedom to launch, the competitor could go to the court and seek judgment on a summary basis. In that event, it should be sufficient for the court to establish that there is no material difference between the biosimilar products. If so, the new biosimilar should be able to rely on the FKB declaration."

On the second question, Adair was keen to emphasise that "the judgment in the FKB case was expressed to be for the purposes of the UK only. The judge went out of his way to say that he was not providing if for 'spin-off value' abroad, albeit that he did say that the declaration should assist FKB in the UK market by making it less likely that foreign courts would injunct FKB's products if elements of FKB's supply chain were abroad." Adair posits that the reality is that foreign courts might be persuaded by an English judgment, but they are not bound by it or compelled to follow it.

The bigger picture

With three approved Humira biosimilars ready to hit pharmacy shelves, and more waiting in the wings, the ability of Humira biosimilar developers to navigate the complex patent 'thicket' that AbbVie has created around Humira remains critical. Despite FKB and Samsung Bioepis having successfully cleared the way in the UK, there is no guarantee that Humira biosimilars will be able to launch outside of the UK, nor that other companies can enjoy the fruits of FKB and Samsung Bioepis' labour.

What next?

European payers are likely to feel aggrieved, as significant pent up demand exists for Humira biosimilars. Interviewed for a forthcoming report, payers from several key European countries suggest that the launch of Humira biosimilars will be the most significant biosimilar launch yet. Whether it's a flood of Humira biosimilars all over Europe, or just a trickle that's limited to the UK, remains to be seen.