The Coming Adalimumab Biosimilar Pricing Free-for-All

The dam wall will be broken when AbbVie’s patents on Humira® are invalidated or expired, or perhaps litigation is settled. This may happen in 2018, 2020, 2022—it is really anyone’s guess, but the one thing that is known for sure is that the day after this occurs, a quite sudden experiment in intensive competition will be underway.

There will be anywhere from 3 to 5 adalimumab biosimilars approved by the FDA when the patent fight is done. Unlike in the Hatch-Waxman Act, where there is an exclusivity period for the first generic market entrant, the BPCIA does not grant a similar benefit for the first-to-market biosimilars. And by the year 2018 or 2020, most expect the 180-day notification period to either be nullified by the Supreme Court or by Congressional legislation. In other words, there will be little restraint on competition.

Manufacturer Product Comments
Amjevita™ (adalimumab-atto)
Approved by the FDA in September 2016
Amgen believes launch in 2017 is unlikely due to patent issues
Boehringer Ingelheim
BI 695501
Filed for approval with FDA and EMA in January 2017; approval decision in Q4 2017
FDA application delayed from Q4 2016 due to manufacturing capacity issues
Phase 3 trial’s top line results reported, FDA application expected in 2017
Coherus Bioscience
Phase 3 trial’s top line results reported, FDA application expected in 2017
Samsung Bioepis
Filed with EMA in July 2016
The Merck Group (EMD Serono)
Phase 3 trials underway for plaque psoriasis (may only target this indication)

Will AbbVie remain in what is still a highly lucrative market for a drug that has paid off its research and development investment many times over? It is likely that with all of the potential players trying to keep their heads above water during the flood of competition, pricing discounts could finally be close to the dreams of payers and other purchasers (≥ 40%). This scenario depends somewhat on whether one player gambles on an early start and markets their product before patent litigation is cleared. This launch “at risk” could alter the competitive landscape. Another possible element could be AbbVie entering into an agreement with Amgen, allowing it to launch well before the others are approved. However, AbbVie’s pronouncements to date seem to be focused on fortifying the dam wall not breaching it.

The only parallel may be the moment the 6-month generic exclusivity expires, and a gaggle of manufacturers launch their products. However, we’re on a completely different level of expenditure and potential savings here. Hopefully, the dam breaks sooner than later.

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