Following the launch of Amgen’s Amjevita (adalimumab-atto), the first biosimilar to AbbVie’s cash-cow immunology biologic therapy, Humira (adalimumab), in the US on 31 January;

Vinie Varkey, Managing Analyst, Immunology at GlobalData, a leading data and analytics company, offers her view:

“For AbbVie, while the threat of adalimumab biosimilars to its blockbuster therapy are finally tangible following close to 7 years of staving off competitors through patents and litigation, the impact on Humira’s revenue will be dictated by how quickly adalimumab biosimilars can capture patient share from the originator biologic, which is an entrenched brand across numerous immunological diseases. A market dynamic that will likely intensify if more adalimumab biosimilars receive interchangeability designation and with increased pressure in the US Pharma market owing to the Inflation Reduction Act of 2022. Currently, Boehringer Ingelheim’s Cyltezon is the only adalimumab biosimilar that has received interchangeability designation.

“To understand how the introduction of adalimumab biosimilars to the US may play out in the immunology space, biosimilars to Johnson & Johnson’s approved biologic, Remicade (infliximab), may provide context. Infliximab biosimilars were the first to grace the immunology landscape, following their introduction in the US over 7 years ago, in 2016.

“According to GlobalData’s forecasts, infliximab biosimilars were anticipated to grow a notable compound annual growth rate (CAGR) of 14% from 2019 to 2029 in Remicade’s leading immunology indications, Crohn’s disease and ulcerative colitis. Further backing this growth trajectory, key opinion leaders (KOLs) interviewed by GlobalData were generally receptive to using biosimilars for their patients, while factors such as pricing and reluctance to prescribe a biosimilar to a patient who is already stable on the originator biologic were identified as critical when deciding on whether to switch a patient to the biosimilar treatment regimen.

“According to GlobalData’s report on ‘Prescriber Opinions on Biosimilars in Immunology’, 43% of US physicians stated that they needed to see a 20 to 40% price discount for them to prescribe biosimilars to greater than 50% of their originator-naïve patients. Whilst for treatment-experienced patients, all US respondents stated they needed to see a 40 to 60% price discount for them to prescribe biosimilars to greater than 50% of that patient group. With Amjevita (40mg) launching at a price discount that is 55% (wholesale acquisition cost) lower than Humira, and a list price that is 5% below the current list price of Humira, Amgen has shown intent to execute a promising pricing strategy. To what extent this tactic would deliver cost savings that are typically associated with biosimilars would ultimately depend on which price point will appeal to pharmacy benefit managers (PBMs). Nonetheless, the launch of Amjevita positions Amgen as a key player in the US biosimilar space.”