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Biosimilars and Pharmacovigilance: What You Need to Know—and Do—Now

Posted on April 26th, 2016 by in Pharmacovigilance


A few weeks ago, the US FDA approved Inflectra (infliximab-dyyb), a biosimilar to infliximab. This is the second US biosimilar approval, suggesting others may soon be on the way—good news for companies with biosimilars pending approval and in development.

The not-so-good news is that FDA regulations with respect to biosimilars continue to evolve, as we noted in our previous post, and continue to lack clarity with respect to pharmacovigilance. This is in contrast to the European Medicine Agency, which has specific requirements for biosimilar pharmacovigilance (PV)—although the PV landscape continues to evolve in Europe, as well.

The most recent US FDA guidance on demonstrating biosimilarity warns, “Robust postmarket safety monitoring is an important component in ensuring the safety and effectiveness of biological products, including biosimilar therapeutic protein products.” The guidance goes on to state that among other factors, such monitoring should take into consideration any safety or effectiveness concerns associated with the use of the reference product anywhere in the world, and be capable of differentiating  between AEs associated with the biosimilar versus those related to the reference product. Postmarketing clinical studies, as well as active monitoring, may be required to evaluate specific safety risks. PV programs in many companies will need to be updated substantially to meet these requirements.

Here’s what you can do right now to facilitate the process:

1- Be proactive. Set up a proactive pharmacovigilance program that mitigates risk across the continuum. The idea of proactively monitoring safety events to better manage risk across the life cycle of a product, and inform products still in the pipeline, is relatively new. But the FDA and EMA recently set up clusters to deal with issues relating to biosimilars and other medicines, and are amending their requirements to promote continuous gathering and analysis of data from as many sources as possible—e.g., peer-reviewed literature, clinical trials, AE reporting systems, regulatory data, social media—as early as possible.

Start now to gather and keep all available safety/AE data about the reference drug and any biosimilars in development by your company or others. Integrate preclinical, clinical and post-market safety data relevant to other biosimilars in the same class for post-market signal detection.

2- Be aware. Naming and labeling of biosimilars continue to be contentious issues, particularly in the US. In addition, multiple manufacturers may be producing the same biosimilar. Even slight variations in the manufacturing process from one company to another may have untoward consequences. Therefore, if you are producing  a biosimilar, it is critical to record complete batch information as part of the PV program.

Also be aware that product identification may be compromised across different healthcare settings.   Whereas oral drugs are dispensed to patients mainly by pharmacists, injectable drugs, including biologics, generally are administered in clinics or hospitals. Both spontaneous AE reporting systems and active surveillance systems depend on accurate identification of the product dispensed or given to patients, yet there is great variability in how health professionals and patients refer to medications in these settings. Barcode technology is emerging as a way to improve traceability.

3- Be prepared. Most companies have a risk-management system in place that enables them to stay compliant with current regulatory requirements for small molecule drugs. But those systems can fall short if, as noted earlier, they can’t address issues related specifically to biosimilars.

Also, many PV programs have evolved over time, and therefore include different platforms and different datasets that are not necessarily compatible. Results can’t easily be compared, often leading to duplication of efforts. This lack of standardization is particularly onerous for companies that implement different approaches across business units, geographies and previous acquisitions.

One solution is to consider investing in a common platform that hosts all relevant data for all products, no matter what type. A single, comprehensive platform facilitates the development of  proactive PV action plans that incorporate multiple datasets into the monitoring process, helping to ensure that all available vital information, published or not, will be flagged for subsequent investigation. A single reliable platform, capable of expanding to meet future requirements, will provide a strong PV program for years to come.

Our next blog will look at the future of PV for biosimilars.

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