Innovator Drug Developers Gain New Indications in Bids to Mitigate Biosimilar Impact

As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.

FDA grants a UC indication for ustekinumab

This week, Janssen announced that the FDA had granted approval for ustekinumab (Stelara) for the treatment of ulcerative colitis (UC).

Approval of the new indication was based on a phase 3 clinical study in which patients with UC received a single intravenous dose of ustekinumab, followed by a maintenance period in which they received subcutaneous ustekinumab treatment every 8 weeks for 44 weeks. In the induction phase, 19% of patients achieved remission by week 8, and in the maintenance period, 45% of patients were in remission—and 43% were in steroid-free remission—at 1 year.

The new indication for the interleukein-12 and -23 antagonist adds to a label that already contains the treatment of plaque psoriasis, psoriatic arthritis, and Crohn disease. The drug was also granted an indication for UC in the European Union in September.

Approval of the new indication comes shortly after biosimilar developer NeuClone announced that it has begun a phase 1 trial of its proposed ustekinumab biosimilar in Australia.

Alexion adds aHUS to ravulizumab’s label

The FDA gave rare disease drug maker Alexion a boost with approval of a new indication for its ravulizumab (Ultomiris), a success for to eculizumab (Soliris) that requires less frequent dosing. The drug is now approved to treat atypical hemolytic uremic syndrome (aHUS), a rare, progressive disease that can lead to irreversible organ damage and premature death.

Ravulizumab, which is administered every 8 weeks versus every 2 weeks for eculizumab, has already gained approval for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), and Alexion is studying the drug in patients with myasthenia gravis.

Alexion said earlier this year that it plans to “convert” its growing base of eculizumab users to ravulizumab as biosimilars of eculizumab approach.

Successor to Humira gets positive CHMP opinion

Finally, AbbVie’s successor to its brand-name adalimumab, Humira, the small-molecule Janus kinase inhibitor upadacitinib (Rinvoq), received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for an indication in rheumatoid arthritis (RA).

The drug maker is now awaiting a final decision from the European Commission, after which, the drug—which is also approved in the United States to treat RA—could help AbbVie to compete in a European RA landscape that now has multiple adalimumab biosimilars available.

While many health systems have reported substantial savings from switching patients to biosimilar adalimumab, upadacitinib could provide some advantages over the older adalimumab; in the SELECT-COMPARE study, upadacitinib outperformed both placebo and adalimumab in terms of the proportion of patients who achieved the American College of Rheumatology (ACR)’s criteria for 20% improvement at week 12 of treatment. The small-molecule drug was also superior to adalimumab in terms of the proportion of patients who reached ACR's criteria for 50% improvement at week 12, as well as in reduction of pain and improvement in quality of life as measured by the Health Assessment Questionnaire Disability Index.