In the coming years, the complex molecules in drug products used to treat diseases which are complex themselves will lose their patent protection. Such is the foreseeable future until 2024 of over 25 anticancer drugs, with annual sales of 20 billion Euros. The unit cost of these drugs, whose mechanism of action is based on molecular therapy, is generally very high. This is due to their complex pharmaceutical and clinical development, but also because they are offered as customized treatment for certain sub-types of cancer and, consequently, for specific patient groups. Fundamentally, they provide personalised therapy, which contrasts with more conventional approaches based on unspecific mechanisms.
The expiry of patent rights of this new generation of anti-cancer drugs (also often referred to as potent or containment products) represents a huge savings opportunity for patients and payers (i.e. in most cases the Government), while also posing a challenge for drug developers and manufacturers. Without the cost of repeating the entire clinical safety and efficacy program and the need to advertise and market the drugs, the latter are able to gain significant market share for the equivalent pharmaceuticals and make them affordable for patients.