Company insight Biosimilar I
n the US, the Food and Drug Administration (FDA) makes a distinction between biosimilars that produce the same clinical results as the reference biologic product and biosimilars that are interchangeable. ‘Interchangeability’ means that a biosimilar can replace a reference biologic without intervention from the prescribing clinician. Though the FDA published a guidance document on interchangeability in 2019, the regulator only approved the first interchangeable biosimilar in July 2021. This suggests a shift in approach in the organisation, which has historically been slower to approve biosimilars compared with the European Medicines Agency, and it is an important milestone for biosimilar manufacturers.
interchangeability
Darren Mansell, regulatory affairs manager at medical device design and innovation company Owen Mumford, explains why understanding the new Food and Drug Administration (FDA) guidance on biosimilar interchangeability is key to innovating drug delivery devices.
may be allowed [in the administration device] if they have no effect on safety and efficacy”. Delivery device innovation can be fundamental to improving patient adherence and outcomes, offering an opportunity to rethink devices with a more patient-centric viewpoint. This means making devices as easy to use and comfortable as possible for intended users. No room for innovation means no room for improvement.
In recent years, the FDA itself has recognised ‘human factors’ as an important consideration in improving the overall patient experience and, subsequently, therapeutic outcomes. If any features of a new drug delivery device are shown to create improvements over the reference product or resolve issues with on-market
“Any guidance on the interchangeability of biological drugs and biosimilars should ideally encourage and facilitate the use of alternatives to the reference device, if it means that patients will benefit.”
This shift may also have implications for medical device development. Since the FDA’s document on interchangeability was released, it has been suggested that the guidance may be impeding innovation in the drug delivery device of the final combination product. Yet a close reading of the guidance demonstrates that the FDA is open to reviewing new product developments.
Innovate and improve
This issue is avoided in the equivalent EU guidance, which makes a distinction between the interchangeability of the drug and that of the delivery device. This separation makes way for device innovation, stating that “some differences
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products, its use should therefore be encouraged by the FDA. Any guidance on the interchangeability of biological drugs and biosimilars should ideally encourage and facilitate the use of alternatives to the reference device, if it means that patients will benefit. Yet, the FDA’s guidance on
interchangeability may actually be stifling any innovation in this area. More specifically, the guidance appears to limit device improvement potential when it states that sponsors developing an interchangeable product generally “should not seek licensure for a presentation for which the reference product is not licensed”. If the reference product is only marketed in a vial and prefilled syringe, for
example, this means that sponsors could not seek regulatory approval for a different presentation such as an autoinjector.
Welcoming pioneers However, just after this, seeking delivery device enhancements that could benefit the patient seems to be encouraged. It is no surprise then that some confusion has ensued for sponsors. Given that improvements in device usability and comfort can offer pharmaceutical companies a competitive advantage over their counterparts, gaining a clear understanding of where the line between ‘similar’ and ‘not-similar’ lies will be important to their sales strategy. This applies both to biosimilar producers trying to gain market share as well as to the original biologic companies seeking to retain their market position. It is likely that pharmaceutical companies will divide into ‘pioneers’ and ‘followers’ – with a group of sponsors sticking closely to the original design of the reference products and others seeking to innovate. To avoid regulatory issues later on, these ‘pioneer’ companies must engage with the FDA in the early development stages and decide on a way forward. It is likely that the ‘pioneers’ bringing device developments to the FDA for approval will trigger greater clarity around the issue. Encouraging developmental debate on the issue within the industry may also help speed matters along. Since the guidance’s initial publication, the FDA has already issued a draft Q&A offering new insights on submissions, including how it anticipates handling applications for interchangeable biosimilars that include data to support licensure as a biosimilar, but not as an interchangeable product. ●
www.owenmumford.com World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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