Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate

A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it.

Four or possibly five manufacturers will be lined up in the starting gate. Fujifilm Kyowa Kirin Biologics and its marketing partner Mylan have not yet received approval from the European Medicines Agency (EMA), but they do have a positive opinion from the Committee on Human Medicinal Products. They expect to hear a final decision from the EMA by October and hope to market it that same month, joining the other adalimumab biosimilar drugmakers.

Those who already have approval to race include:

Manufacturer/Marketing  Partner

Molecule Designation

Brand Name

Samsung Bioepis/Merck
SB5
Imraldi
Boehringer Ingelheim
BI 695501
Cyltezo
Amgen
ABP 501
Amgevita
Sandoz
GP2017
Hyrimoz
Adapted from: http://www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab.

Several other manufacturers are also in the running, but will be late entries. They have completed phase III studies but their biosimilar adalimumab applications are not yet filed: Coherus, Pfizer, Fresenius, and Momenta.

adalimumab biosimilarsOn October 16, Abbvie’s Humira® patent expires and the starting gate should open. We’ve not seen anything similar in the US biosimilar market. Even when Abbvie’s patents expire in 2022 and agreements go into effect, this will be more of a staggered start, with Amgen having first crack at the market in January 2023 followed by Samsung Bioepis in June of that year. That is, unless another biosimilar manufacturer refuses to sign a licensing agreement with Abbvie and launches at risk earlier.

In any case, the savings seen in the EU should be immediate and if competition is not hindered, adalimumab biosimilar prices will be slashed. It will be interesting to see how this situation plays out, with one of the world’s biologic sales leaders.

It will certainly leave American payers dreaming about what could be, but will not be, for several years at least.

Leave a Reply