This year started off with a bang for rheumatology biosimilars, with several regulatory approvals around the world, new market insight into the global use of biosimilars, and US market introduction of the first rival biosimilar to Humira (adalimumab).
The year started off with a bang for rheumatology biosimilars, with several regulatory approvals around the world, new market insight into the global use of biosimilars, and US market introduction of the first rival biosimilar to Humira (adalimumab).
Global Regulatory Approvals and Launches
The biggest news to come out of January was the US market introduction of the first adalimumab biosimilar (Amjevita, Amgen). The drug references AbbVie’s Humira, one of the most profitable drugs in the world, and will be used to treat several rheumatic conditions, including rheumatoid arthritis (RA), Crohn disease, ulcerative colitis, and psoriatic arthritis (PsA). 2023 marks the year where between 8 and 10 adalimumab biosimilars will launch in the United States after settlements from patent infringement cases resulted in all biosimilar manufacturers postponing the launches of their adalimumab competitors.
Additionally, Health Canada approved the high-concentration, citrate-free version of Hadlima, an adalimumab biosimilar developed by Samsung Bioepis and Organon. The high-concentration, citrate-free formulation allows for less injection site pain and for patients to go longer between adalimumab doses. The extended approval comes nearly 5 years after the Canadian agency approved the low-concentration version in May 2018.
Celltrion Healthcare has some regulatory progress as well for its infliximab biobetter, Remsima SC. The FDA accepted Celltrion’s biologics license application (BLA) for the biobetter, which builds on the company’s infliximab biosimilar (Remsima) that references Remicade. Remsima SC differs from Remsima in that it allows for subcutaneous administration. The original Remsima was approved by the FDA in April 2016 and launched on the US market in November 2016.
Similarly, the FDA accepted a BLA for Alvotech’s ustekinumab biosimilar (AVT04) referencing Stelara. If approved, AVT04 will be used in the treatment of PsA, plaque psoriasis, and inflammatory bowel disease. Shortly after, Alvotech along with its partner Bioventure received regulatory approval for an adalimumab biosimilar (AVT02) in Saudi Arabia.
Overseas, China’s National Medical Products Administration approved the world’s first tocilizumab biosimilar (BAT1806), which was developed by Bio-Thera Solutions. The biosimilar references Actemra (tocilizumab) and will used to treat RA, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
Global Market Insights
In IQVIA’s Global Use of Medicines Report for 2023, biosimilars were projected to generate $290 billion in savings around the world through 2027. However, this estimate was lower than previous predictions, suggesting a greater need for policies that encourage biosimilar utilization.
Additionally, the report predicted that spending in the immunology field will experience a slowed growth rate of 3% to 6% through 2027 due to biosimilar competition. Immunology biosimilars could see a 12% annual growth rate, and overall spending in the space is projected to grow by 24% by 2027 to $34 billion, with more than half of the drugs representing most of the spending in the space expected to face generic or biosimilar competition in the next 5 years.
Controversy and Clinical News
A controversial retrospective real-world analysis out of Italy claimed that switching patients between reference adalimumab and adalimumab biosimilars resulted in a greater likelihood of loss of effectiveness. The study contrasts the experience of the European Union and Canada, who have extensive experience switching patients between adalimumab products without impacting clinical outcomes, and other published bodies of evidence that demonstrate the safety of switching.
Alvotech announced the commencement of a phase 1 study assessing the pharmacokinetics, safety, and tolerability of its golimumab biosimilar (AVT05). Reference golimumab (Simponi and Simponi Aria) is used to treat RA, PsA, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.
Finally, a case study of a pediatric patient with scalp and nail psoriasis found that treatment with an adalimumab biosimilar followed by monitorization with in vivo reflectance confocal microscopy resulted in improved outcomes after 24 weeks.