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When It Comes to Patient Safety, Caution Isn’t a Four-letter Word

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.

History shows us that producing traditional generic drugs is, relatively speaking, a simple process.  Molecule A in a known amount, combined in a known manner with Molecule B in a known amount will produce effect C every time.

However biologics, because they begin with living organisms rather than chemicals, present many more obstacles to manufacturers, regulators, prescribing physicians and, of course, patients.

Over time, the European Medicines Agency (EMA) has issued biosimilar guidelines for the authorization procedure and has an excellent track record here in the EU and around the world, but it gained this reputation by insisting on rigorous testing and clinical data.  Ensuring a high level of patient safety, product quality and efficacy is paramount. And although this stringent process may be, at times, frustrating to companies – we always have to remember that a public body’s primary responsibility is to protect its citizens.

The U.S. has a similar regulatory agency in the Food and Drug Administration (FDA).  The FDA recently held a hearing on how best to proceed in the complicated, but vitally important area of creating a pathway for biosimilars in the U.S.  As new advances in cell manipulation provide potentially better medications for an ever-widening range of diseases and conditions, it’s becoming more and more important to countries, like the U.S. to implement a suitable roadmap for biosimilars that protects patient safety, spurs innovation, and expands access to the life-saving medicines.

The FDA could learn a lot from the years of thoughtful research and extensive testing the EMA did to create a regulatory pathway for biosimilars.  Our process is safe, effective, fair to manufacturers, and promotes long term research investment that leads to the medical discoveries of tomorrow.

Biologics and the biosimilars they spawn are bringing hope to patients around the globe who are suffering from cancer, arthritis and other diseases and disorders.  With more than 300 biologic medicines already approved by the FDA and another 600 in development, the future of medicine is nearly here.  Policymakers – on both sides of the pond – need to make it their mission to protect the safety of their population and ensure that the medicines available to the public are the safest and most effective possible.

It’s important for regulators and legislators to take a judicious and cautious approach to approving medicines.  This is especially the case in transformative discoveries of next generation medicines.  There really is no substitute for patient safety and no shortcuts to ensuring it.

Jorgo Chatzimarkakis, PhD, is a member of the European Parliament and, since 2006, a member of the member of the Pharmaceutical Forum, a high level group designed to provide a political mandate for relevant public health issues. He launched the European Life Science Circle (ELSC), a platform to discuss relevant issues in the context of life sciences and pharmaceuticals.

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