What Do Providers Need to Know About Biosimilars?

DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom

With a number of new biosimilars making their way to market and eventually to the clinic, it is crucial that healthcare providers become educated about and comfortable with biosimilar products. During a session at the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, experts addressed a number of key areas for provider education.

Paul Chamberlain, immunogenicity specialist at NDA Advisory Services, spoke about one of the biggest concerns for prescribers who are wary of biosimilars: immunogenicity

Here’s a summary:

According to Paul, it is critical to clarify the definition of immunogenicity, which is an undesirable host immune response to administration of a therapeutic agent. The innate immune response, the adaptive immune response, and immune tolerance are the key drivers of immunogenicity, and product factors (such as glycans, process-related impurities, or process changes) and patient factors (such as comorbidities or concomitant therapy) can impact the balance of those 3 factors.

While it is not feasible to predict how each factor might interact with others to affect immunogenicity, he explained, individual factors can certainly be controlled within acceptable limits. Furthermore, regulators look at both the individual and population level for immune response, and they also require a well-defined risk management plan for a product.

Thus, said Paul, immunogenicity is “the wrong elephant in the room” for prescribers, because physicians typically conflate the incidence of antidrug antibodies (ADAs) with immunogenicity. “Please do not just use ADA rate … as a term which is equivalent to immunogenicity. It absolutely isn’t.”

To illustrate his point, Paul gave the example of CT-P10; in looking at ADA titters between the biosimilar rituximab and its reference, regulators can see that while ADA rates for the 2 products may not appear comparable, the ADA titters overlap very closely. However, he said, few physicians see these reassuring data.

For a more complete picture please see Pauls slide presentation.

To read more about what the experts had to share please click here.