Expert Discusses Quality Standards' Role in the Evolution of Biosimilars and Biologics Landscape


Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses how established quality standards, drawing from the realm of small molecule drugs and evolving to meet the complexities of biologics, play a pivotal role in fostering trust.

Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses how established quality standards, drawing from the realm of small molecule drugs and evolving to meet the complexities of biologics, play a pivotal role in fostering trust, accelerating regulatory approvals, promoting competition, and ultimately transforming patient care by enhancing access to biosimilars and biologics.

biosimilar word or concept represented by wooden letter tiles on a wooden table with glasses and a book | Image Credit: lexiconimages -

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Q: How do the existing quality standards for small molecules pave the way for quality standards in biologics and biosimilars?

3 Key Takeaways

  1. Quality standards, inspired by the successes in small molecule drug regulation, are essential for building trust and confidence in the consistency, safety, and efficacy of biologics and biosimilars among patients and health care providers alike.
  2. Implementation of robust quality standards not only accelerates regulatory approvals but also fosters competition, driving down health care costs and increasing patient access to a wider range of affordable treatments.
  3. Embracing a platform-based approach to standardization enables more efficient development and approval processes for biologics and biosimilars, exemplified by the rapid response seen during the COVID-19 pandemic, ultimately revolutionizing patient care and therapeutic innovation.

Fouad Atouf: There are a lot of lessons to leverage from the world of small molecule drugs and if anything, the existing quality standards for small molecules show that having standards 1 it works 2 provide a basic framework for approaching quality standards. We also know that we recognize that the components of standards are different for biologics. We talked about complexity of this product, as it is the case for small molecule standards are critical because they can confirm the identity purity, functionality, and potency of ingredient across manufacturers and in a global landscape. Also, by using standards, you can trust that a medicine will perform the way it should be performing.

I want to add that standards have been shown to increase regulatory confidence, reduced the cost of developing medicines, which unlocks resources for innovation, and increases the supply of treatment available for patient. Now, with biologics, you need to take an additional set of factors into account like the type of raw materials that is used in the manufacturing process can have implications on the outcome of that manufacturing process. When you have standards and tools to control this processes you now can improve the efficiency in product development and the consistency and I think the path to approval subsequently getting new and innovative medicines to patient.

Q: How do the existing quality standards for small molecules pave the way for quality standards in biologics and biosimilars?

Fouad Atouf: As a matter of fact, with biological medicines, in general, there are special considerations that impact the level of trust the public has in this type of product, whether it's a reference biometrics or a biosimilar version. Some of the concerns that patient and practitioner may have relate to consistency of biological medicine just if you compare batch to batch and as an example, but that's where standards can play a role and help ensure that consistency and building trust among clinician.

The other point relates to the technologies that are used for testing and the type of analytical method that are currently in place. All of that should be enough to give patient and clinician the confidence in the quality and efficacy of both originator biologics and biosimilars. So, standards present an opportunity to help bring more confidence to the development process and speed up regulatory process for approvals and get more of these drugs to the market faster. Having trusted reference materials and standards, quality control frameworks, and other tools that are widely adopted can build that confidence across every step of the process and the product development journey, and it can aid in meeting regulatory expectations which in turn can increase the availability supply and safety of new medicines in the US and globally.

Q: How do you foresee the implementation of quality standards influencing the marketplace for biosimilars and biologics, if applicable?

Fouad Atouf: In general, implementation of standards has huge positive implication, and this does not apply only to the pharma industry or pharma biopharma product, it applies actually to all the goods that we consume. Standards should only accelerate the development and approval of biologics and biosimilars when testing strategies are standardized, you will have consistency in quality. Manufacturers will be able to provide a more affordable solution to patient and more consistent solution, as they will be able to put the resources to our research and development and rely on those uniform tools that have been provided by a standard setting organization. Now they can use those uniform tools across manufacturers and regulators.

When we talk about standards, and again, in my opinion, it applies actually, not just to this industry apply to other industries, but in this context, we're talking about publicly available standards and how this standards facilitate regulatory approvals and can eliminate costly and time consuming duplication of effort as manufacturers can rely on public standards to test product quality, instead of having to develop their own methods on standards at every step.

The other interesting element around public standards is that they promote competition by supporting the entry of multiple manufacturers into the market of buyers can product just like it has been the case for generic drugs for small molecules. There are actually great lessons to learn from the US experience in the past almost 15 years with the establishment of a robust biosimilar regulatory pathways, but there are also of course, the European experience that is worth actually taking a moment and looking at how is that helping the world shape how we approach biosimilars. Europe is a good example of where standards for biologics and biosimilars have been effective. We know that Europe is the forerunner in the biosimilar market and regulatory system for drugs has linked public quality standards to biosimilar market authorization. For the past two decades, the European Medicines Agency has implemented a well-established legal and regulatory pathway for the approval of biosimilar product, and the guidelines from that agency, recommend the use of international standards recommend to manufacture to include the use of international standard in the development and the guidelines also recognize that biologics are more complex. I think we know that and they're sensitive to changes in manufacturing compared to small molecule type of product so I think that the safety, efficacy and that's from that European approach, the safety efficacy profile of this product is highly dependent on the robustness and monitoring of quality of this type of product. Part of the European Framework and when it comes to quality assessment of biosimilars are there is a requirement to satisfy the technical requirements in the monographs set by the European Pharmacopoeia. Manufacturers has taken advantage of that. They have been able to utilize public standards in product development and cite them in the regulatory filings and applications. If we combine the lessons from Europe, from the US, from other parts of the world, we now have additional considerations as the US continues to implement its biosimilar regulatory framework. But back to that European perspective and experience, if anything, it shows that public standards for biosimilars will play a critical role in ensuring patient and provider confidence in the quality of this product. They facilitate competition. They help accelerate regulatory approval and ultimately reducing the overall health care costs.

Q: Considering the promise biosimilars hold for patient access, how do you see the landscape evolving with the establishment of quality standards?

Fouad Atouf: The premise here is that the establishment of quality standards should help to accelerate development and approval of biosimilars which could transform patient care. So that's it. We also need to keep in mind that standards need to evolve and meet the current needs and adapt to advances in technologies and requirements in the case of biologics, and biosimilars, the one thing from in our experience is that using a platform-based approach, when it comes to standardization, holds a lot of promise to this concept of using a platform approach for standardization and setting standards is actually similar to the platform approach for manufacturing.

For standardization, platform approach developed standard that support a whole family of product as opposed to a single product. This helps bring more products to the market and more efficiently. The comparison to manufacturer and drugs. This approach has proved actually to be successful during the COVID-19 public health crisis, when manufacturers had to accelerate the clinical development for complex biologics to meet the emergent needs. In the case for mRNA vaccines. As we all know, manufacturers were able to generate clinical batches of their vaccines within weeks of the publication of the sequence of source code to genome. That's because the same process used to develop one mRNA vaccine can be used to produce vaccines against new variant, or even new diseases with minimal number of changes to the process and formulation. The modality is the same regardless of the disease target, and this reduces the resources needed to create an in house standards for quality controls, and helps accelerate the development of new therapeutics.

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