Relatively few prospective studies have been published in relation to adalimumab biosimilars in patients with IBD, according to the authors of the study.
A paper in Plos One describes how their prospective observational study - clinical monitoring - was performed at seven gastroenterology departments across the Czech Republic in outpatients older than 18 years of age, with those patients evaluated between June 2019 and August 2021.
Hulio and and Hyrimoz were indicated to 50 naive patients with Crohn’s disease (CD) or ulcerative colitis (UC).
The effectiveness of the therapy was evaluated via the Crohn’s Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy.
In CD patients, remission was achieved in 73.5% of cases, partial response in 11.8% of others, no response in 11.8% of cases, while 2.9% patients discontinued therapy. In UC patients, remission was achieved only in 18.8% of cases, partial response in 43.8%, no response in 25% of cases and 12.5% patients discontinued therapy. The researchers also saw there were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin, and CRP serum levels after 12 weeks of therapy.
Seven adverse events were identified, three of which resulted in therapy being discontinued.
The team concluded that their study proved the effectiveness of the two adalimumab biosimilars in IBD. However, they stressed that larger, double-blind, randomized, prospective, long-term studies are necessary to be done to provide further data about efficiency and safety of therapy with biosimilar adalimumab.
Viatris’ Hulio and Sandoz’ Hyrimoz are approved in the EU and in the US, referenced to AbbVie’s blockbuster drug, Humira. However, they are not scheduled to launch in the US until 2023.
Meanwhile, the US Food and Drug Administration (FDA) recently approved a citrate-free, high-concentration (100 mg/mL) formulation of Samsung Bioepis and Organon's Hadlima, also an adalimumab biosimilar.
It is authorized for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Hadlima (adalimumab-bwwd) will be available in pre-filled syringe and autoinjector options, said the companies.
The drug was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019. Organon said it anticipates launching Hadlima in the US on or after July 1, 2023.
US Humira biosimilar market share
Earlier in August, Teva Pharmaceutical Industries gave a bullish assessment of its chances of claiming a big slice of the Humira biosimilar market, arguing it has “the best product profile of all companies coming to the market in 2023.”
AbbVie reported US$17.3bn in Humira sales in the US in 2021, up 7.6% versus the prior year. Growth in the US has enabled AbbVie to continue increasing sales in the US even as off-patent competitors to the TNF inhibitor have caused revenues to contract internationally.
Next year marks the arrival of biosimilar rivals to Humira in the US. Amgen is set to be first to market, with its rival to Humira on track to come to market in January. Then, in July 2023, Teva and a clutch of other biosimilar developers will introduce their own copies of AbbVie’s blockbuster.
Sven Dethlefs, executive vice president, North America commercial at Teva, set out the key dates in the fight to win market share from AbbVie on a second quarter results conference call on July 27.
“I believe the uptake will be largely defined by the contracting strategies of [pharmacy benefit managers] and our customers, how they think they would like to build the biosimilar market versus the offer that they get from AbbVie,” said Dethlefs. “That will be a two-step approach. One will happen in 2023, primarily in the summer of 2023, and then you will see a second phase in 2024, when the whole book of contracting will be opened again.”
Payers told to act
Much of the future of the biosimilars sector in the US depends on whether that incoming wave of Humira biosimilars will be placed on formularies as they become available, argues Julie Reed, executive director of the Biosimilars Forum, a US not-for-profit organization.
“It is a watershed moment for the industry and for the marketplace as the countdown clock has started for the sequential launch in 2023 of seven adalimumab or Humira biosimilars in the US. This is where the rubber hits the road and it is up to the Biden Administration, to Medicare, to the private commercial payers, and to the pharmacy benefit managers (PBMs) to act and support the launch of these new low-cost biosimilars on the US market.
“These payers, and Medicare, need to put these Humira biosimilars on their drug formularies. It is a serious issue if they don’t because we all know that the more biosimilars competing at the one time with the reference biological, the greater the cost savings, the faster the prices go down.
“This is a huge opportunity for the US biosimilars sector and the wider pharma industry, a sea change, but it is now in the hands of the government and the payers to make this happen,” the executive told BioPharma-Reporter
The members of the Biosimilars Forum represent the companies with the most significant US biosimilars development portfolios. They have spent 6-8 years and around US$1.5bn in total in developing these Humira biosimilars and getting them approved, noted Reed.
“They could launch, though, and not have any access to the market if the administration, the private commercial plans and the PBMs don’t do anything. And that would have a negative effect on the industry overall.”