ViewPoints: AbbVie's US Humira empire safe for now, but EU physicians are chomping at the bit for biosimilars

(Ref: ViewPoints Desk)

It is perhaps no wonder that AbbVie has confidently predicted Humira sales will swell to around $21 billion by the end of the decade; biosimilar competitors look increasingly unlikely to enter the US market by this point.

With AbbVie having recently reached a settlement with Amgen, which will delay the launch of AbbVie's biosimilar – Amjevita – until 2023, ongoing litigation between AbbVie and Boehringer Ingelheim is now set to delay launch of a second biosimilar – Cyltezo – by a similar timeframe.

New filings indicate that a trial relating to active litigation between the two companies is approximately three years away, delaying any potential launch of Boehringer Ingelheim's biosimilar until 2022 at the earliest, estimate analysts.

While there are other companies pursuing development of biosimilar Humira products, Cyltezo is widely viewed as providing the biggest near-term threat to branded Humira sales, notes SunTrust Robinson analyst John Boris.

Like Amjevita, Boehringer Ingelheim's biosimilar has already been approved by the FDA, but is also being studied in the first interchangeability trial that meets provisional criteria set out by the US regulator. Nevertheless, both Boris and Bernstein's Ronny Gal believe the likelihood of Boehringer Ingelheim reaching a settlement with AbbVie similar to that agreed with Amgen has increased.

Delay to the availability of biosimilar Humira could have significant implications for the broader market, argue biosimilar advocates, and US payers have suggested as much themselves – Spotlight On: US payer – "Humira is the one biosimilar product we are actually waiting for"

AbbVie's product represents the biggest commercial opportunity for biosimilar developers by some margin, although the size of potential damages any company would be liable for – if they were to launch a biosimilar at risk and were subsequently found to infringe AbbVie's intellectual property – means such a scenario is very unlikely.

The risk is that delay to the entry of biosimilar Humira products in the US market accentuates development of a two-speed biosimilar industry along geographic parameters, with European adoption rates already accelerating away from the limited commercial success of biosimilars in the US. 

Not only are biosimilar versions of Humira expected to launch in Europe next October once patent expiry has occurred, but discussions with regional key opinion leaders (KOLs) reflects the increasing comfort that European physicians have with biosimilar products.

Commenting to FirstWord on psoriasis efficacy data recently presented for Novartis' Humira biosimilar GP2017, experts largely share a consensus that biosimilars are interchangeable with the equivalent branded originator and any prior concerns relating to quality, safety or efficacy have largely been dispelled with experience gained in recent years.

Batch-to-batch variability of branded biologic product was cited as a suitable analogue for variability between biosimilars and branded originators, and echoing previous comments from US payers, EU KOLs believe that availability of biosimilar Humira could play a pivotal role in expanding use of biologic therapy across a large number of patients over multiple indications. By comparison, US physicians may have to wait at least five more years until they can use biosimilar Humira.

Further reading

Spotlight On: Will AbbVie's short-term Humira gains have long-term consequences?

Spotlight On: Boehringer Ingelheim sets the pace for interchangeable biosimilar status with new study, but implications of this additional regulatory benchmark remain hard to predict