Patient Safety and biological medicines: what matters?

Biologics are made by genetically engineering living cells to become miniature ‘factories’ producing the desired molecules (proteins). These living cells are inherently variable and susceptible to slight changes in their environment that can significantly alter the proteins they are engineered to produce. Because no two living cell lines are identical, no two biologic manufacturing processes have identical starting materials or proceed in the same way. A follow-on biologic manufacturer that uses different starting materials and a different process will produce a product that is different from the innovative product. The effects of the differences between a follow on and its respective innovator product can only be determined by subjecting the follow on biologic to substantial clinical testing in patients to prove that it is safe and effective. Therefore technically it is not possible to have a "generic" of a branded biologic.

The safety and efficacy of biologics are key issues in the whole patient safety debate. One of the main concerns in the prescribing biologics to patients is the process of ‘automatic switching’ which means that medicines agencies are able to authorise the automatic switching of a biologic treatment to a generic which is less expensive than
the innovator. The switching could occur mid way through a patient’s treatment risking the possibility of undesirable reactions between the switched product and the patient’s immune system.

It can be argued that in order to reduce the risks associated with biologic switching, the prescribing doctor should decide whether to switch from one molecule to another and not the medicines agencies. As each patient has a different profile only the treating doctor will know how the patient is likely to react. Moreover this information will only become evident to the treating doctor following rigorous clinical testing.

On 8 November, The Parliament Magazine and Novo Nordisk, in association with EuropaBio, hosted an event to debate whether automatic switching of biologic treatments is safe for patients and how this issue can be integrated into future EU patient safety legislation. It also discussed how biologics will be addressed in the forthcoming clinical trials directive, the risks associated with counterfeiting and issues of pharmacovigilence.

This debate was hosted by Marisa Matias MEP.

Click here to view photos from the event.

Click here to view a PowerPoint on The EU’s role in supporting research on drug safety by Stéphane Hogan, Head of unit Health Directorate, DG Research & Innovation, European Commission.

Click here to view a PowerPoint on Patient safety and Biological medicines: what matters? by Anne Felton, President, FEND.

Click here to view a PowerPoint on Biosimilars by Inger Mollerup, Corporate Vice President, Regulatory Affairs, Novo Nordisk.