- The Food and Drug Administration has cleared the third biosimilar in the U.S. of AbbVie's best-selling Humira, granting approval on Wednesday to Novartis' copycat version Hyrimoz.
- Patients and physicians, however, won't see the likely cheaper biosimilar until Sept. 30, 2023, the launch date agreed upon by Novartis and AbbVie in a settlement deal reached earlier this month.
- Thanks to a strong ring of patents around Humira, AbbVie has largely locked out biosimilars from the U.S. market until 2023. The Chicago-based drugmaker has reached agreements with three other competitors-to-be that set out launch dates throughout that year.
Hyrimoz's delayed entry following approval is a familiar fate for biosimilars in the U.S. Of the now 13 biosimilars cleared by the FDA, only five to date have launched.
Patent litigation has largely blocked entry of the rest, including two other Humira biosimilars made by Amgen and Boehinger Ingelheim, while contracting issues have limited the impact of those that are currently available.
It's a state of affairs that's drawn complaints from government officials like FDA Commissioner Scott Gottlieb as well as from the ranks of big pharma itself.
Europe, on the other hand, has enjoyed a functioning biosimilar market for years, and biosimilars are beginning to bite into sales of several previously protected blockbuster biologics.
Humira presents the largest market opportunity by sales and, on Oct. 16, four copies of the biologic began rolling out to markets across the EU.
In a twist, though, it could be AbbVie itself that ends up offering the steepest discount out of the gate. Reports surfaced Oct. 31 that the Humira maker won the first national biosimilars tender in Europe by steeply discounting its brand 80%.
As Evaluate notes, biosimilar discounts in Europe frequently reach 50% — by cutting its price so significantly, AbbVie appears to be aggressively defending its prescription volume. (Such a discount also hints at a low cost of goods sold for Humira.)
Possibly in response, shares in AbbVie were trading down 3.5% on the New York Stock Exchange Wednesday afternoon.
AbbVie reports third quarter earnings on Friday. Investors have already factored in declines for Humira in Europe, but such a strategy could force some to revise their forecasts.