USP Expert Discusses Concerns on Biosimilar Safety and Efficacy Through Quality Standards


Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses the importance of robust quality standards in addressing concerns regarding biosimilar safety and efficacy.

Fouad Atouf, PhD, senior vice president of global biologics at US Pharmacopeia, discusses the importance of robust quality standards in addressing concerns regarding biosimilar safety and efficacy, highlighting their role in building trust among patients and providers and emphasizing the need for collaborative efforts to enhance access to these critical medicines.

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Q: What specific concerns do providers and patients have due to biosimilar safety and efficacy?

3 Key Takeaways

  1. Robust quality standards are vital for addressing concerns surrounding biosimilar safety and efficacy, serving as a cornerstone in fostering trust among both patients and health care providers.
  2. Collaborative efforts involving industry, academia, government, and organizations like USP are essential in enhancing access to biosimilars, requiring reforms in payment systems and streamlining regulatory approaches.
  3. Increased patient access to biosimilars necessitates not only quality standards but also broader systemic changes, emphasizing the multifaceted approach needed to ensure the availability and affordability of these critical medicines.

Fouad Atouf: I think the focus on patient is very important when it comes to adoption of biosimilars because at the end of the day, that's what at the heart of this may be questioned in my opinion. This type of drugs offer incredible promise to provide increased access and potentially lower cost for patient with chronic conditions. They do, actually, biosimilars go through rigorous testing and regulatory process. But despite that rigor, some patient and clinician may continue to have questions about the overall effectiveness and safety of biosimilars compared to the reference biological product.

In another piece, maybe of information that can inform on this question is a 2017 survey that included over a little over 1200 physician from different specialties and coming from different regions globally. That survey indicated the need for a knowledge-based education about biosimilars. Specifically, the research highlighted some of the gaps that are related to biosimilars maybe simple examples, such as the inability to correctly define some of the terminology like extrapolation and interchangeability in the context of this, biosimilar landscape. This study also identified a lack or like a poor ability to articulate the difference between biosimilars and an originator.

Back to what I said already, we know that biosimilars go through a rigorous testing by manufacturers who follow the same robust quality assessment as the reference product. In the US, for example, this quality assessment is performed in accordance to applicable regulations, which are enforced by the US FDA. So, in my opinion, what we need to do as a community is to implement more education programs around the steps that are involved in ensuring the quality of biosimilars and so that provider can have that confidence and increase the knowledge and trust in biosimilars and then support greater patient access and prescribe and use those medicines.

Just maybe one last point on the education aspect. One example that the [US Pharmacopeia] together with the US FDA created a couple of years ago, and educational resource, which is an infographic that helps increase awareness with patient and health care providers about biosimilars product quality.

Q: How does the lack of awareness among providers impact the adoption of biosimilars in the market?

Fouad Atouf: I'm not an expert in this specific area, but maybe we can unpack some of the facts around these questions, and I'm going to start with the fact that the US FDA approved and continues to approve many biosimilars that are used to treat a variety of diseases and conditions. That is a result of biosimilar medicines growing faster than any other segment of medicines. But despite that, unfortunately, patient access to biosimilars is oftentimes limited by health plan formularies and rebating practices, and sometimes it can lead to a few biosimilar options for prescribers and patients, even when the list price of a biosimilar product, maybe 80% less than a reference product as an example.

I think what we know today is like at least 45 biosimilar have been approved by the US FDA since the approval of the first biosimilar back in 2015, and another, maybe, a piece of information that can help with this with this point is it's a fact that comes from the 2023 US generics and biosimilar medicines savings report, which highlight that the US health care system saved over $400 billion in 2022 by using FDA approved generics and biosimilars. So as more and more patents for biological drugs expire, we will continue to see biosimilars emerge as cost effective alternative for patients and clinicians. However, it would be really important that clinicians understand that biosimilar are as equally effective as versions of branded biologics and stop prescribing those drugs as quality alternatives to increase the adoption.

Q: Can you elaborate on what type of quality standards exist for biologic medicines?

Fouad Atouf: I will start with a historical example but also a very well-established type of standards within the USP as an example for how quality standards for biological medicines can support this paradigm. Since the introduction of USP’s insulin standards back in the 1940s, many other biological standards have been continuously developed, revised, and updated to keep pace with the rapid advances in technology and regulatory paradigm. The USP standards don't work just by themselves, I think it's side by side with other types of standards. I'll mention here the international standard by World Health Organization. Together the USP standard and the international standard have supported the development of insulin, as this family of product grew to include new analogues, new dosage forms and of insulin. So today, there are many USP standards for insulin, and they cover most of the insulin that are currently in the marketplace in the US.

Now, we need to acknowledge that when, this is back to biologics in general, we need to acknowledge that when compared to conventional medicine modalities, the complexity of developing manufacturing and manufacturing large molecule biologics requires that we think differently about how we measure the critical quality attribute. I think the moment you say how to measure quality attribute, it also has implications on how we set standards. I think by thinking actually of that complexity, it helps us bring more quality assurance therapies to the patient.

What does USP do in this space? I will say that we take a comprehensive approach to ensure the quality at every stage of the product lifecycle. We start with the quality control, the qualification, and standard to support like raw materials that are used in manufacturing, but also looking at some of the safety aspect by looking at assessing impurities, using different types of analytical tools, with an overall goal to really support quality management throughout the entire lifecycle for a biological product.

Then the question: how do we develop those standards? We do this by taking a platform approach, where solutions can support platforms or technologies that apply to families or classes of drug product, not just like when I own a single product, and may be a good example, in the space of monoclonal antibodies, which is an important portion of the pharmaceutical segment. USP has documentary standard reference standard and the USP monoclonal antibody reference standards that we have in place can be used by manufacturers and developers in their effort to develop methods and analyze the quality attribute for a variety of monoclonal antibodies not just a single molecule. This approach to biological standardization aims to define a framework for quality that can be used across multiple biologics and broaden their impact and ability to get to market.

Q: How do you envision these quality standards addressing the other concerns of both patients and providers regarding the safety and effectiveness of biosimilars?

Fouad Atouf: I think this speaks to how we build trust, which we just talked about and, at the end of the day, patient care is primarily about access, availability of this medicine, and then obviously, about therapeutic equivalence., and, of course, staying safe. In a way, the intricacies of how a product is tested, aren't as meaningful to them, but knowing that the treatment that they've been given has been quality tested and quality assured, and need quality standards that inspire confidence in the patient population is something that can really help with that trust.

The other thing I want to mention is that quality standards also help health care providers trust that a framework that prioritize quality was followed. I think it add to that trust. This is really key to helping providers feel confident that the drugs and therapies they're prescribing and administering are, for example, free of microbial contamination, the level of impurities has been controlled, according to safety requirements, and these are critical aspects of evaluating safety and effectiveness that actually do that drug. When you use a standard, you ask the question, what does it mean? Well indicate that a drug has undergone a science-based, rigorous testing to ensure quality and purity. So, we're talking about, you know, originator and biosimilars for biosimilars. Specifically, as long as biosimilars are held to the same quality standards as the reference product, and they are, we should feel confident that they meet the quality expectation.

Q: Is there anything else you would like to add?

Fouad Atouf:There are a couple of things maybe that I touched on that I want to re-emphasize. One is increased patient access to biosimilars. Yes, we'll need robust analytic tools standards, but I think it's not just the full picture. Increased patient access to this critical drugs, biosimilars will require reforms to payment systems, including formularies and rebaiting, streamlining of product development, testing, and regulatory approaches.

The other point is it is important that all stakeholders come together at this point and collaborate on ways to enhance access to biosimilars which are truly critical medicines. No one organization can do this by themselves. It requires bringing together industry, academia, government, and USP and this convenient power is one of our central roles.

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