The US Food and Drug Administration (FDA) approved Pfizer’s Humira (adalimumab) biosimilar, to be known as Abrilada, for all indications of the originator product.
As a result, Pfizer’s Abrilada will join a long list of companies that are waiting until 2023 to bring their product to market in the US.
There are already biosimilar competitors on the market in Europe, with entry in late 2018 and strong sales for those manufacturers that were early to commercialize.
However, in the US, patent protection has afforded AbbVie some breathing room before biosimilars turn to take a chunk out of this market, where the company recorded sales of $13.6bn (€12.2bn) in 2018.
For Pfizer, after FDA approved its latest product, the company now holds a portfolio of eight approved biosimilars. However, the company made decision to trim away its extended pipeline of potential biosimilar products, after an internal R&D investment review.
Pfizer has long decried businesses practices that have seen the biosimilar market slow to take off in the US; however, in its latest financials, the company was able to point towards strong growth during 2019 as a positive sign for its portfolio of biosimilars.