Developing Quality Assurance Standards for Biologics, Biosimilars

Learning from Small-Molecule Drugs

“There are a lot of lessons to draw from the work that USP has done on setting standards for small molecule drugs and how that paved the way for showing how standards work,” Atouf began. However, he noted that it is crucial to acknowledge that the complexity of biologics may impact the specific standards for these compounds.

Even so, the general principles around developing standards for biologics are the same as those for developing standards around small molecule drugs. They are crafted to ensure the product's identity, purity, functionality, and potency globally.

“What we need to do is to take a slightly different approach and almost dissect the biological product to understand where actual standards can be developed,” emphasized Atouf. “Is it on the raw material that is part of the manufacturing of the product? Is it the impurities? By dissecting those different components, we can develop a whole package.”

Rather than call it a set of standards, Atouf referred to it as a solution package that addresses multiple components. He mentions that many modalities and manufacturing platforms used in the production of biologics and biosimilars are alike, which is why USP is looking to develop a standard that can work across multiple biologics.

“Biological products made in different settings will use slightly different processes and yield different impurities,” he explained. Addressing that requires focusing on the platform used to create the product.

“By looking at the technologies used for manufacturing and the technologies used for, focusing on standardization for the platform itself or the technology addresses the bigger question, which is how to ensure that the process is consistent?”

The Importance of Quality Standards

“Standards are fundamental because they have shown they can support increased regulatory confidence, reduce the cost of developing medicines, and provide consistency across manufacturers,” Atouf mentioned to PharmaNewsIntelligence.

Availability and Innovation

In addition to increased confidence and accuracy, setting standards for pharmaceutical products can help bolster the supply chain, making drugs more available to a broader range of patients.

“Standards can have only a positive implication on the availability of quality medicines, and standards can help accelerate the development of logical products. They allow the developers to use available methods and standards to focus the resources on more pressing issues like continuing to innovate.”

Patients and Providers

Beyond availability, Atouf mentioned how setting quality standards can impact other stakeholders, such as patients and providers.

The patient is one of the main benefactors of setting quality standards. Enforcing these standards fosters trust — to some level — between the pharmaceutical industry, manufacturers, regulatory organizations, and the consumer.

However, the more significant benefit for patients is improved access. As Atouf mentioned early in his conversation with PharmaNewsIntelligence, setting quality standards helps improve supply chain resilience and sustainability. While patients may not necessarily care about detailed components of quality standards, they do care about having access to safe and effective medications.

“What helps them trust the medicine is knowing that the product was quality assured and tested. It inspires that confidence.”

While patients are not necessarily gathering intricate quality assurance data on their pharmaceutical products, prescribers and licensed healthcare professionals may be using that data to make decisions about which products to recommend or prescribe.  

“It's imperative to, as we think of patients, to think of the healthcare provider who is working with them. Practitioners knowing that the framework used to test for quality has been designed to ensure quality and safety and that those principles have been followed properly makes the practitioner feel confident that the drug they're going to administer to their patient is of the expected quality,” Atouf added.

Whether or not the process is simple, providers want to know the products they prescribe are functional for the indication, free of contamination, and free of any impurities.

Future Innovation in Quality Assurance

Although the quality assurance of biologics and biosimilars remains challenging, researchers and organizations have been working on improving the standards in place for these products.

Atouf highlights the importance of learning from previous innovations and developments and applying that knowledge to future advancements.

“Science is universal. There is so much information out there. There's a lot of knowledge to leverage and different organizations collaborating. There’s a lot of discussion on which developers should tackle critical quality attributes as they advance the regulatory filing to agencies for approval.”

“The field has evolved, and we learned a lot in the last two decades between the experience in Europe and the US and the rest of the world by developing and [bringing] proven biosimilars to market,” Atouf noted.

But, even with significant progress in quality protocols, more development is necessary. Atouf emphasizes the need for collaborative efforts among stakeholders to develop robust and comprehensive quality assurance protocols.

“It’s important to recognize that no organization can do this by themselves, and it would require bringing stakeholders from industry, academia, government, and USP. USP has a central role as a convener.”