As the looming patent cliff approaches, some major blockbuster drugs are set to lose their exclusivity, with pharma companies making moves to try and reduce the impact.
Patent expiry is a phenomenon that haunts every pharmaceutical company, with the loss of market exclusivity often causing a dramatic dip in a company’s profits. This can be particularly challenging for companies whose drug is one of their best-sellers – having the potential to wipe billions from revenue figures.
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With a particularly large wave of drug patent expiries set to hit the industry in the coming years, the spotlight on the state of biopharma pipelines has intensified.
To combat the challenges associated with the patent cliff, pharma companies are increasingly licensing new and promising assets, with many looking to China for this as the country enhances its output of potential first- and best-in-class pipeline assets.
However, companies are also revamping their best-selling medicines – improving aspects like durability, route of administration, potency, tolerability, and more, to extend their market potential in the face of biosimilar competition.
This trend is strongly observed in the oncology and ophthalmology sectors, which have seen a wide range of drugs get an upgrade upon an approaching patent cliff. This includes MSD’s best-selling cancer asset, Keytruda (pembrolizumab) – which recently got the subcutaneous (SC) upgrade – as well as Bayer and Regeneron’s longer-acting Eylea follow-on, Eylea HD (aflibercept), which was approved in 2023.
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By GlobalDataIn conversation with Pharmaceutical Technology, experts previously noted that the transition from intravenous (IV) to SC was a “major shift” in the oncology sector back in 2023.
Now, analysts and experts alike hold varying opinions on the current and future market potential of such therapies in oncology, ophthalmology and beyond.
Updated formulations refresh oncology space
With a wide range of larger pharma companies introducing updated, SC formulations of their once IV-only therapies, patients across the globe are gaining access to medications that offer better patient centricity, while potentially reducing the time spent receiving treatment.
According to Jack Cuthbertson, oncology analyst at GlobalData, the parent company of Pharmaceutical Technology, medical systems could also reap the benefits of these new formulations.
“Cancer treatment clinics are often limited by ‘chair times’, or the amount of time it takes to deliver treatment,” Cuthbertson says. “New formulations reduce this from hours to minutes, resulting in significant overall savings for healthcare service providers.”
Cuthbertson notes that it’s a similar story for payers, who will likely face lower costs through the use of SC drugs.
However, Cuthbertson and GlobalData oncology healthcare consultant, Israel Stern previously mentioned that the treatment edge these updated therapies possess may be dulled when used in combination with IV treatments like chemotherapy, antibody-drug conjugates (ADCs) or immunotherapies. In this scenario, Cuthbertson believes that SC formulations are “unlikely to be chosen as they will not increase patient convenience over an IV biosimilar”.
John Singer, founder and executive director of Blue Spoon Consulting, acknowledges the benefits that updated formats of best-selling drugs can provide to patients, though he caveats that uptake may not necessarily follow the easier route of administration if that pathway is blocked by “economic incentives which favour IV”.
In Singer’s opinion, the commercial success of a newer formulation will be seen on a case-by-case basis – influenced by markets and disease areas.
One therapeutic area that he sees particular economic interest in novel dosage formats – namely oral medications – is the obesity market, with oral glucagon-like peptide 1 receptor agonists (GLP-1RAs) holding the potential to “offer significant economic value”.
Ophthalmology avoids patent cliff through durable therapies
In the realm of ophthalmology, Sara Reci, managing analyst at GlobalData, notes that newer drug formats can significantly soften the impact of the patent cliff if they offer tangible benefits to a treatment’s durability.
“In the case of wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME), new formulations that extend dosing such as Eylea HD or Vabysmo (faricimab) offer immediate, concrete value. This means that the updated products often see rapid uptake, despite premium pricing,” Reci states.
In the case of Eylea HD, Reci believes that its adoption was – in part – so quick because it “leverages strong familiarity with standard-dose Eylea”, while offering a straightforward value proposition of durability.
Though newer formulations may offer enticing benefits, Reci caveats that healthcare systems are more likely to prioritise cheaper ophthalmology biosimilars once they have been proven clinically equivalent to the branded alternative and safe for use. Despite this, she acknowledges the growing implementation of newer, more durable and patient-centric formulations that can “clearly reduce injection burden and overall system costs”.
“Hospital committees make exceptions for drugs that offer high treatment durability, as they cut the necessary frequency of administration. This means that their prolonged activity of 12-16 weeks can offset the higher unit price by diminishing the burden of regular treatment on healthcare systems and patients themselves,” Reci states.
While these therapies have seen strong uptake in wAMD and DME, Reci notes that this is not the case for another ophthalmic indication, geographic atrophy (GA) – mainly because the therapy offers modest benefits with monthly injections, leading to a more cautious pattern of uptake.
Preparing for the patent cliff
While some revenue losses following patent expiry are inevitable, Cuthbertson says that companies may better stave off the impacts of the patent cliff within the oncology sector by creating fixed dose, combination SC formulations similar to Genentech’s blueprint with Phesgo (pertuzumab trastuzumab hyaluronidase).
He touts this strategy as novel formulations combining two commonly utilised therapies will add new value to each drug – offering them in a more convenient and effective dosing form covered by further patent umbrellas.
Meanwhile, in ophthalmology, Reci believes the key driver of differential commercial success is a new product’s capacity to offer quantifiable administration or durability compared with the original branded therapy. She also stresses the importance of “convincing clinical and pharmacoeconomic data that aligns with payer incentives”.
Singer adds that the commercial success of a therapy also depends on strategically reframing or repositioning therapies to “progressively integrate their storyline and value in a way that’s going to be a better strategic fit to where the world is going economically”.
In his eyes, this means that companies should consider a drug’s positioning within the broader context of its disease area’s ecosystems, which includes factors like diagnostics and care, as well as delivery and workflow.
For those creating updated formulations, Singer believes that conceptualising and managing a portfolio of such products before the panic sets in can help companies gain commercial success.
