Could 2023 be a pivotal year for biosimilars?
6 January 2023
Insights from Roderick Ball.
Since the launch in 2015 of Hospira’s Inflectra® (infliximab) – the first biosimilar monoclonal antibody – we have seen an increasing rate of adoption of biosimilars. This is particularly true for Europe, where the market share of biosimilar monoclonal antibodies for the management of inflammatory diseases and cancer is now over 90%.
However, much of the rest of world, notably the US, have been playing catch up. For example, as of September 2021, biosimilar rituximab and infliximab together accounted for less than a third of US prescriptions for rheumatological conditions. And until recently, we had seen a similar market share for biosimilar infliximab in the management of inflammatory bowel disease. This relatively slow US adoption of biosimilars represents a profound opportunity cost to its healthcare system – while only 2% of US prescriptions are for biologics, they account for over 40% of healthcare spend; an annual drugs bill of over $200 billion.
2023 will be an important year for the ongoing commercialization and adoption of biosimilars globally for myriad reasons, with three key factors shaping this.
Adalimumab biosimilars launch in the US
2023 heralds the much-awaited arrival of adalimumab biosimilars in the US, which could prove a game-changer. Although the FDA approved the first adalimumab biosimilar in 2016, their market availability has been on pause as AbbVie leveraged its extensive and complex patent protection for Humira® (adalimumab). January will finally see the launch of Amgen’s Amjevita® (adalimumab-atto), with nine more adalimumab biosimilars expected to follow later this year; including those from Pfizer, Sandoz and Boehringer Ingelheim.
These past five years, Humira, which is currently the biggest-selling drug in the world, has earnt AbbVie over $60 billion from US sales. So, unsurprisingly, optimising cost savings from the arrival of biosimilar competitors will become a key priority for pharmacy benefit managers (PBMs) and insurance companies alike in 2023.
However, several factors may challenge US adoption of the adalimumab biosimilars.
Firstly, how aggressively AbbVie decides to price Humira to defend its market share will be critical. Until recently, the price of biosimilars has not been a pivotal factor in driving US market share like it has been in other markets, such as Europe. Originator companies have used mechanisms such as attractive rebate schemes aligned to broader product portfolios to overcome the lower biosimilar prices being offered. Of course, these types of anti-competitive practices have not been available to originator companies in Europe. But now, recent US policy initiatives have helped re-establish the price mechanisms, and adalimumab biosimilars will be launching into a more predictable price-led market.
Secondly, AbbVie will look to leverage healthcare professional (HCP) and patient loyalty. When choosing their adalimumab of choice, PBMs and insurance companies will be focusing first and foremost on price. However, if Humira’s new price point compares with biosimilar competition, value added services such as AbbVie’s nurse support program may be an important consideration – but just how important remains to be seen.
Thirdly, unlike biosimilars such as infliximab and rituximab, adalimumab is administered subcutaneously. This means that patients switching to biosimilars will need to be reassured and trained to self-inject using a different device. The pharmacist will play a key role in supporting patients to ensure the switch happens successfully.
Beyond patient support, pharmacists will play an increasingly important part in driving adoption of those adalimumab biosimilars with ‘interchangeability’ status, a designation that will likely be assigned to several of them. Practically speaking, this means pharmacists can automatically substitute a biosimilar adalimumab in place of a Humira script without prescriber consultation, as they can do for generics, within the limits of their state’s laws on substitution.
Finally, while HCPs may accept the rationale for switching patients, introducing biosimilars to patients whose disease has been successfully managed with the originator drug may be met by scepticism and concern from patients.
We know the language used by HCPs to introduce biosimilars has a significant impact upon patient acceptance. A poorly managed conversation may lead to the patient feeling aggrieved and viewing the biosimilar as an inferior treatment. Consequently, they may report a subjective deterioration of their condition or increase in side effects – the so-called nocebo effect.
To mitigate this, PBMs and insurers will need to carefully coordinate the introduction of biosimilar adalimumab with educational support programs to ensure HCPs and patients are, at worst, ambivalent to switching from Humira or, at best, see the potential benefits of doing so.
First biosimilar launched for multiple sclerosis
In 2023, we will see the US and European launch of Sandoz’s intravenous (IV) natalizumab biosimilar for relapsing forms of multiple sclerosis (MS). This will be the first biosimilar launched into the neurological field and will be a direct competitor to Biogen’s originator, Tysabri® (natalizumab).
However, in contrast to recent launches of biosimilars into the immunology and oncology therapy areas where there are only a handful of ‘cornerstone’ treatments, natalizumab is one of over twenty available treatments for MS.
That said, Tysabri is worth over €800 million in Europe and over $1 billion in the US. So in 2021, to defend against future biosimilar competition, Biogen launched subcutaneous Tysabri in Europe. However, in the US, the FDA decided not to approve the subcutaneous formulation; the reasons why have not yet been made public.
Interestingly, Roche previously adopted a similar subcutaneous defense strategy, launching subcutaneous Herceptin® (trastuzumab) at a discount before the arrival of IV biosimilar trastuzumab. The aim was to maximize the number of patients switched to subcutaneous Herceptin before biosimilars arrived. This approach successfully limited uptake of biosimilar trastuzumab in some key European markets, such as France, where biosimilar market share remains at only 45%. Whether Biogen’s approach of not offering a discount for subcutaneous Tysabri will have a similar impact in defending their market share remains to be seen.
Beyond Biogen’s subcutaneous defense strategy, the adoption of the IV natalizumab biosimilar will depend on many other factors. As this is the first biosimilar in the neurology field, effective HCP and patient education programs will be critical to its acceptance and uptake. The latter will be perhaps more important than in other therapy areas, given the high level of patients’ engagement and involvement in how their disease is managed.
Interchangeability
A further driver for biosimilar adoption in Europe in 2023 may result from the EMA’s recently published position on interchangeability.
In September 2022, guidance was provided saying that any EU-approved biosimilar may be considered interchangeable; this is at odds with the FDA’s position, which designates interchangeability on a case-by-case basis based upon submission of supporting data by the manufacturer.
While this is guidance, it will be interesting to see whether member states – who are responsible for policy regarding automatic substitution (i.e., dispensing one medicine instead of another without prescriber consultation) – will look to drive further biosimilar adoption by mandating this approach. Consequently, pharmacy education about biosimilars is key to support their increasing role and responsibility in driving their adoption.
Questions for 2023
2023 will be a defining year for biosimilars, particularly given the availability of adalimumab biosimilars in the US.
Will this finally be the tipping point for the US to begin to realize the eye-wateringly large cost savings associated with biosimilars? Will PBMs and insurers, who are most likely to profit from this, put adequate incentives in place to support their adoption? Or will stuttering adoption result in biosimilar manufacturers questioning their decision to commercialize in the US?
How will the MS HCP and patient community embrace the first biosimilar treatment?
And will the EMA interchangeability guidance see biosimilars approach the generics model in terms of automatic substitution?
Some big questions with some big implications for biosimilars.
From Impact's perspective, a good part of our focus in 2023 will be developing and delivering HCP and patient support programs to support adoption of one of the adalimumab biosimilars being launched in the US. It’s going to be a fascinating journey!
Impact is a global healthcare communications agency, with a particular specialism in launching and supporting biosimilars. To find out more about what we do, click here.
Bibliography
https://www.centerforbiosimilars.com/view/fda-approves-idacio-the-eighth-adalimumab-biosimilar
https://mstrust.org.uk/news/under-skin-injection-tysabri-gets-licence-uk-and-ireland
https://link.springer.com/article/10.1007/s40259-020-00461-8