By JORGO CHATZIMARKAKIS

Around the world and now in the United States, there is a broadening discussion of how best to proceed down the path of approving and getting to market medicines called biosimilars.  Biosimilars are non-identical copies of next generation medicines known as biologics.  As the U.S. begins establishing new guidance for biosimilars, regulators and legislators should look to the European Union model on guidance policy and approve these important, often life-saving, drugs when they are proven to be safe for the patients they are intended to heal.

There is justified debate and concern both here in the EU and other nations on how best to introduce biosimilars into the marketplace.  We know from the science, that it’s immensely more difficult to  produce a biosimilar than a generic version of a traditional drug.  And with this increased difficulty, comes increased risks to patients in the form of efficacy and drug-to-drug interactions.  However, by adding biosimilars to the treatment regimen, we can hope to see long-term therapy at the lower costs that biosimilars may be able to provide.  This is important to every country struggling to meet the demands of an aging population and rising health care costs.

As policymakers this dilemma is made easier because our focus must always be on patient safety.  Citizens trust that their nation’s regulatory bodies are looking out for their best interests and doing their due diligence to ensure a safe drug supply.  So patient safety is our starting point, our ending point, and our path along the way.Continue reading…