Overview of Humira® Biosimilars: Current European Landscape and Future Implications

Jp, Coghlan; He, Hongliang; Schwendeman, Anna

doi:10.1016/j.xphs.2021.02.003

Cited by 26 publications

(14 citation statements)

References 33 publications

(29 reference statements)

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“…The changes in process strategy described in this study can also be of particular interest for upcoming processes to produce biosimilars, as it will increase margins and put even more pressure on competitors, for example, before biosimilars for blockbuster drugs such as Humira® will enter the (United States) market. 48 It is to be emphasized, that all experiments described can be conducted rapidly, with the result that the intensification of an existing process can be evaluated within only a few weeks using multi‐parallel small‐scale bioreactors. This allows for a significant and rapid increase in production capacity.…”

Section: Discussionmentioning

confidence: 99%

Rapid intensification of an established CHO cell fed‐batch process

Schulze

Niemann

Wijffels

et al. 2021

Biotechnology Progress

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Currently, the mammalian biomanufacturing industry explores process intensification (PI) to meet upcoming demands of biotherapeutics while keeping production flexible but, more importantly, as economic as possible. However, intensified processes often require more development time compared with conventional fed-batches (FBs) preventing their implementation. Hence, rapid and efficient, yet straightforward strategies for PI are needed. In this study we demonstrate such a strategy for the intensification of an N-stage FB by implementing N-1 perfusion cell culture and high inoculum cell densities resulting in a robust intensified FB (iFB). Furthermore, we show successful combination of such an iFB with the addition of productivity enhancers, which has not been reported so far. The conventional CHO cell FB process was step-wise improved and intensified rapidly in multi-parallel small-scale bioreactors using N-1 perfusion. The iFBs were performed in 15 and 250 ml bioreactors and allowed to evaluate the impact on key process indicators (KPI): the space-time yield (STY) was successfully doubled from 0.28 to 0.55 g/L d, while product quality was maintained. This

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Section: Discussionmentioning

confidence: 99%

Rapid intensification of an established CHO cell fed‐batch process

Schulze

Niemann

Wijffels

et al. 2021

Biotechnology Progress

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“…In our model, we estimated that the 5 adalimumab biosimilars approved during the study period would capture 46% of the US market within the first 3 years post‐launch. However, adalimumab biosimilars had already captured over 63% of the UK market 6 months after launch and over 50% of the Germany market 1 year after launch 18 . Our model further estimated a 21.3% reduction in originator adalimumab price between September 2016 and December 2019.…”

Section: Discussionmentioning

confidence: 66%

“…We assumed a market capture rate of 1.25% per month for the first adalimumab biosimilar in the first year following launch, equating to a 15% market share by the end of the first 12 months. This assumption was based on the data on adalimumab‐atto, which captured approximately 15% of the German adalimumab market within 1 year 18 . Based on estimated annual market penetration of 15 biosimilars for 3 originator products in the European Union, we further assumed a 5.5% market share (0.46% per month) for each successive adalimumab biosimilar 1 year post launch.…”

Section: Methodsmentioning

confidence: 99%

Cost to Medicare of Delayed Adalimumab Biosimilar Availability

Lee

Najafzadeh

Kesselheim

et al. 2021

Clin Pharma and Therapeutics

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Launched in 2002, originator adalimumab (Humira) is the top revenue‐generating drug in the United States. Between 2016 and 2019, the US Food and Drug Administration approved 5 adalimumab biosimilars, yet none have been marketed owing to patent dispute settlements. We sought to calculate the cost of this delayed entry to Medicare over this period by estimating the difference between reported spending on originator adalimumab and estimated spending on originator and biosimilar adalimumab products assuming timely biosimilar market entry. Estimates of potential biosimilar spending were calculated based on the following evidence‐based projections: (i) market capture of 15% for the first biosimilar and 5.5% for successive biosimilars in their first year on the market, and 5% annually thereafter; (ii) price reductions of 3.5% per year and 2.4% per additional biosimilar entry for originator adalimumab; and (iii) price discounts of 25% at launch, 3.4% per year, and 1.7% per additional biosimilar entry for biosimilar adalimumab. Based on these assumptions, had adalimumab biosimilars launched upon approval, estimated non‐rebate spending on them would have been $18.3 million in 2016, $225.7 million in 2017, $436.2 million in 2018, and $727.7 million in 2019, whereas estimated non‐rebate spending on originator adalimumab would have been $2.33 billion, $2.04 billion, $1.78 billion, and $1.42 billion. Cumulative spending on adalimumab would have thus been $8.98 billion instead of an observed $12.11 billion. Accounting for estimated rebates, total predicted savings would have been $2.19 billion. Reforms for timely biosimilar availability will be critical in ensuring optimal savings for Medicare after biosimilar approval.

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“…TNFα is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation such as seen with autoimmune disorders (Willrich et al, 2015). Adalimumab is a monoclonal antibody that inactivates TNFα thus reducing its inflammatory effects (Nuti et al, 2015;Willrich et al, 2015) and sold under the brand name Humira ® (AbbVie, Lake Bluff, Illinois, United States), among others (Scheinfeld, 2003;Coghlan et al, 2021). This monoclonal antibody has been used to treat a variety of inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and uveitis, among others.…”

Section: Discussionmentioning

confidence: 99%

“…However, in the last decade or so, more targeted biotherapeutics, notably monoclonal antibodies directed at specific cytokine targets, have been developed and shown to be highly effective therapies for a range of autoimmune diseases (Lefebvre and McAuliffe, 2016;Jung and Kim, 2022). Some of the clinically available monoclonal antibodies are directed at tumor necrosis factor-alpha (TNFα) (Abramovits and Gupta, 2004;von Richter et al, 2019;Coghlan et al, 2021) and (Raychaudhuri, 2013;Kolbinger et al, 2022;Wohlrab et al, 2022;Xu et al, 2022;Yun et al, 2022) which underlie inflammatory responses in many autoimmune diseases. However, as with all biotherapeutics, the pain associated with frequently injecting these antibodies impacts patient compliance and disease management and several pharmaceutical companies have attempted to address this issue by developing infrequent dosing regimens with less painful and more convenient pen injectors for delivering these antibodies (Kivitz and Segurado, 2007;Karlsdottir et al, 2022).…”

Section: Introductionmentioning

confidence: 99%

Transenteric delivery of antibodies via an orally ingestible robotic pill yields high bioavailability comparable to parenteral administration in awake canines

Yamaguchi

Dam²,

Dhalla³

et al. 2022

Front. Drug. Deliv.

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Biotherapeutics such as peptides and antibodies are highly efficacious clinically but, unlike conventional medications, cannot be administered orally as they get digested and inactivated. Thus, biotherapeutics require parenteral routes for delivery, such as intravenous, intramuscular or subcutaneous administration. However, these delivery methods have limitations such as poor patient compliance or may require clinical supervision compared to oral therapies. We explored whether a novel, orally administered transenteric delivery system (Robotic Pill) could provide equivalent bioavailability to parenterally administered drugs. Utilizing an awake canine model, we demonstrated that orally administered Robotic Pills containing either human IgG or an anti-cytokine monoclonal antibody directed against either TNFα or interleukin-17A yielded bioavailability equivalent to parenterally administered controls. The ability to achieve clinically relevant blood levels of biotherapeutics via any orally administered preparation represents an important advance in drug delivery.

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Overview of Humira® Biosimilars: Current European Landscape and Future Implications

Cited by 26 publications

References 33 publications

Rapid intensification of an established CHO cell fed‐batch process

Rapid intensification of an established CHO cell fed‐batch process

Cost to Medicare of Delayed Adalimumab Biosimilar Availability

Transenteric delivery of antibodies via an orally ingestible robotic pill yields high bioavailability comparable to parenteral administration in awake canines

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