Improving Treatment Outcomes: Biosimilars

At the start of his session, “Biosimilars in the Treatment of IMIDs: A Potential Path to Improved Outcomes”, presented at IAS 2022, Jonathan Kay, MD, discussed the biosimilars and their place in treating IMIDs.

He opened with pointing out the cost burden of biologics in the United States, noting that there has been a significant increase in biologics since 2014, with a compound annual growth rate (CAGR) of 14.6%, which outpaced the 1.6% CAGR for small molecules.

Next, Dr Kay discussed exactly what biosimilarity means and what biosimilars are. He noted that, per the regulatory definition of biosimilarity in the United States, “The biologic product is highly similar to the reference product notwithstanding minor differences in clinically inactive components [and] there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.”

He defined a biosimilar as, “a legitimate copy of a biopharmaceutical that no longer is protected by patent, which has undergone rigorous analytical and clinical assessment, in comparison to its reference product.” He added that these have been approved by a regulatory agency for biosimilar evaluation.

He then touched upon the biosimilars approved by the FDA and commercially available for inflammatory diseases, which include:

• Rituximab
• Adalimumab
• Etanercept
• Infliximab

However, he specified that for adalimumab, the pharmaceutical company has reached agreements with many developers, forestalling US market entry until 2023.

He continued by sharing the misconceptions regarding biologics and biosimilars. One of which is that biosimilars are not generics. He cited how biosimilars are biologic medications made in living cells whereas generics are small molecule drugs that are synthesized chemically, amongst many other differences.

Another misconception he then addressed was how commercial lots of bio-originators are not identical. He shared how small modifications in the manufacturing processes could result in gradual changes. He also presented recent data showing the chemical characterization of different commercial lots of etanercept and rituximab, which were produced between 2007 and 2011, and how they revealed variations in both C-terminal lysine content and glycosylation.

At the end of his presentation, Dr Kay summarized by stating that all biologics can be varied taking into account drift and evolution occurring over time. He added that changing from bio-originators to their biosimilars in clinical trials has no correlation in the loss of efficacy, increased occurrence of adverse events, or immunogenicity. Additionally, he argued that the availability of biosimilars creates market competition that has decreased the cost of biopharmaceuticals.

“If the actual cost of a biosimilar is not lower than that of its reference product following discounts and rebates, then the availability of the biosimilar introduces market competition that results in effective treatment for patients with the reference product at a lower cost,” he concluded.

Reference
Kay J. Biosimilars in the treatment of IMIDs: a potential path to improved outcomes. Presented at: Interdisciplinary Autoimmune Summit; April 21-24, 2022; Virtual.