Patient safety standards are non-negotiable

Today’s post is written by Jeremy Morgan, Vice President, International, Lilly Diabetes. Jeremy Morgan is a member of the Board of The European Association for Bio-Industries (EuropaBio) and Vice-Chair of EuropaBio’s Healthcare Council. 

As my colleague Vladimir Kopernicky said last week at the Politico Annual Health Care Summit in Brussels, high safety standards of medicines are non-negotiable. Safety of medicines is paramount in protecting and promoting the health of the patient. This principle lies at the heart of the numerous considerations from regulatory pathways to procurement practices discussed this week at the Financial Times Global Pharmaceutical and Biotechnology Conference in London, where I joined industry colleagues in discussing biosimilar medicines. 

Let me first give you some context. Biological medicines can only be made in living cells and as a result, have a unique, complex, and highly-controlled manufacturing process. Furthermore, they can only be used via some form of delivery device (like an infusion or injection device). ‘Biosimilars’ are biological medicines that are highly similar to the original biological medicine but not identical.

In the discovery, development and manufacturing of all medicines at Lilly, it is always about meeting the needs of patients. For example, in diabetes, my own area of expertise, the development of biosimilar medicines to address unmet patient needs makes a lot of sense given our heritage in supporting patients manage such a complex condition.

However, while biosimilars can be a good option, they may not always the best option for everyone. Patients and their physicians need to make the final treatment decisions concerning whether a person should receive a biosimilar, and biosimilars should only be used when specifically prescribed.

Under the right circumstances biosimilars can enhance the existing market ecosystem in the EU by offering alternatives to existing biological medicines that have lost their exclusivity rights, and potential economic benefits to healthcare systems creating greater headroom to fund new innovative treatments. What is critical is that policies are patient led and that both here in Europe, and in the US, policies reflect the difference between innovative biological medicines and biosimilars, and ensure patient access to the treatment that is most appropriate to them. 

I was fortunate enough to share my views at the FT’s conference this week in London, but if you weren’t there and fancy reading more on the subject, check out our infographic on where biosimilars policy stands in Europe: