The expiration of patents on many oncology drugs paves the way for equivalents and biosimilars, with savings of up to 80%. But among the lowest-cost tenders, paybacks and shortages, critical issues emerge for patients, businesses and the National Health Service.
The expiration of numerous patents oncology drugsincluding immuno-oncologists who have revolutionized cancer therapy, represents a decisive turning point for the future of National Health Service. The entrance of equivalent and biosimilar drugs it is often described as a spending containment measure. «But talking only about savings is an understatement», he clarifies Stefano Collatina, president of Egualia, Italian association of producers of equivalent drugs, biosimilars and value added medicines. «Saving is the tool. The real objective is to expand access to care and free up resources to reinvest in innovation.”
Biosimilars and innovation: savings that generate access
The healthcare system faces an increasingly rapid and costly wave of innovation. “We don’t have enough funds to finance all the innovation that comes to the market,” observes Collatina. «The expiration of patents and the arrival of competition is the physiological mechanism that allows us to recover resources». The precedent of the large oncology biologics is emblematic. «Before the patent expires, three molecules such as trastuzumab, rituximab and bevacizumab were worth around a billion euros a year in Italy. Today they cost around 200 million. In other words, what we used to spend to treat one patient now allows us to treat five.” Price reductions of up to 70-80% which translate into a real expansion of the patient base. “Greater access means this: more people treated, more equity, more timeliness.” According to the president of Egualia, equivalents and biosimilars they are now an integral part of clinical practice: «They are not series B drugs. They are consolidated therapies, used every day in Italian pharmacies and hospitals, which treat the large mass of patients».
Immuno-oncology: the next big patent expiration
The next test concerns the immuno-oncologyamong the most revolutionary therapies of the last ten years. «In metastatic melanoma we have gone from a poor prognosis to survivals of 40-50%. It is an extraordinary result.” But these are high-cost treatments. «Let’s talk about therapies that can reach 40-45 thousand euros per patient and which globally generate revenues in the order of tens of billions.” Their patent expiration opens up relevant scenarios: «In the next few years, drugs worth between 200 and 300 billion in the world will go off patent. The savings and reinvestment potential for the Italian healthcare system is evident.”
Oncology drug shortages: What it means for patients
If the prospects are positive on the access front, the chapter shortages of oncology drugs tells a more fragile reality. Official AIFA data indicate that approximately 15% of the missing references concern oncology and that, in a third of cases, there are no therapeutic alternatives. «When there is no alternative, the drug must be imported from abroad», explains Collatina. «This involves time, administrative costs and a significant organizational burden». For an oncology patient, the deficiency can translate into a real risk. «In oncology, time is of the essence. We are not talking about a headache, but about pathologies that can progress rapidly.” The protocols are defined based on the stage of the disease and its biological aggressiveness. «Some flexibility exists, but any deviation from the standard protocol is an emergency solution. It would be better not to have to adopt it.” The case of 5-fluorouracil in 2024 was emblematic. «It is a historic chemotherapy, still central in the first line of colorectal cancer. We were only able to guarantee treatment thanks to imports from abroad. Without that possibility, patients would have been left without standard therapy.”
Maximum discount tenders and payback: the crux of industrial sustainability
The causes of the shortages are not just logistical. «70% of the active ingredients are produced in Asia. If a plant shuts down, the entire supply chain is affected.” But there is also an internal issue of pricing and procurement policies. «In Italy we have hospital prices among the lowest in Europe, even 30% lower than in other large countries». Low-cost tenders, often with a single successful bidder, further compress margins. «If the price becomes unsustainable, companies exit the market. And when players are reduced, the risk of shortages increases.” It also has an impact the payback mechanism. «Today it can exceed 16% of turnover. Removing further percentage points from products already offered at the maximum discount puts industrial sustainability at risk.” The paradox is clear. «If a tender is designed only to lower the price and ends up reducing the number of suppliers, the objective is not achieved. Without drugs, the price goes up and the system weakens».
Equivalents and biosimilars as a strategic pillar
In the new geopolitical scenario, with Europe discussing the return of strategic production to the continent, the role of producers of equivalent and biosimilar drugs becomes central. «We cannot rely only on cost», concludes Collatina. «Medicine is an essential social good. We can do without many things, but not drugs.” The challenge is to find a balance between economic sustainabilitysecurity of supply e access to cancer care. «Equivalents and biosimilars are not a marginal chapter of healthcare spending: they are the condition that allows us to guarantee care for everyone and, at the same time, to finance innovation that saves lives».
