FDA Accepts BLA for Novartis Adalimumab Biosimilar

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for biosimilar adalimumab to the brand reference medicine Humira.

The biosimilar, from Novartis division Sandoz, is indicated for the treatment of inflammatory diseases such as rheumatoid arthritis (RA), plaque psoriasis, Crohn’s disease, and ulcerative colitis.

Sandoz's application demonstrated adalimumab’s safety, efficacy, and quality through a pharmacokinetic study in healthy participants, as well as a phase 3 confirmatory safety and efficacy study (ADACESS) in patients with moderate to severe plaque psoriasis, according to the company.

The ADACESS study randomized patients to either biosimilar or reference therapy in 3 different treatment periods. The first 17-week period featured eligible patients with moderate-to-severe chronic plaque psoriasis.

In the second period, patients were re-randomized into 4 groups, with the first 2 groups continuing the originally assigned treatments, while the other 2 switched to alternating treatment every 6 weeks, until week 35. In the third period, patients received their initially-assigned treatment until week 51.

Psoriasis Area and Severity Index 75 (PASI75) response rates for those receiving biosimilar adalimumab throughout the study were 75.2% at week 17 and 84.5% at week 51, compared with 67.8% at week 17 and 79.6% at week 51 for patients who received continuous treatment with the reference medicine.

The BLA acceptance comes just a week after Novartis announced the recruitment of the EXCEED trial, a head-to-head clinical comparison of brand Cosentyx (secukinumab) versus Humira for psoriatic arthritis (PsA). It will be the first large double-blinded head-to-head trial comparing the 2 therapies for PsA, based on improvement of ACR 20 scores at 52 weeks of treatment.

Mark Levick, Global Head of Development, Biopharmaceuticals, at Sandoz, said in a statement that it is imperative patients with chronic diseases have access to important medication.

“The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the US who suffer from an inflammatory disease,” Levick said.

Approximately 1.5 million US patients suffer from RA, according to Sandoz, with 200,000 new cases diagnosed annually.

Data released from the QuintilesIMS Institute report on health care spending showed that Humira lead all drugs in invoice spending in 2016, with $13.6 billion spent on the AbbVie therapy. That rate was $3 billion more than the next best-selling drug, and it marked Humira’s fifth straight year atop the list.

In the same report, researchers projected an impact on AbbVie’s stake in the rheumatology market due to emerging adalimumab biosimilars. The FDA previously approved Amgen's adalimumatto (Amjevita), as a biosimilar in September 2016. In January of 2017, early top-line results of a phase 3 trial showed that Pfizer’s PF-06410293, another biosimilar to adalimumab, met its primary endpoints in safety and efficacy.