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Sandoz Hits Back At Biosimilar Misinformation

Global Biopharma Head Insists That “Biosimilar Information Battle” Will Be Won

Executive Summary

Pierre Bourdage, global head of biopharmaceuticals at Sandoz, has hit back at false statements and misleading claims around biosimilars that persist despite mounting evidence to the contrary.

Sandoz’ global head of biopharmaceuticals, Pierre Bourdage, has insisted that the industry must continue to push back against misinformation around biosimilars that persists despite mounting evidence in their favor, maintaining that the “biosimilar information battle” will be won.

Responding to an article titled “The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape” published in the Advances in Therapy journal, Bourdage set out in a LinkedIn post multiple criticisms of misleading claims made around biosimilars, also drawing on the input of fellow Sandoz executives Michael Wiechmann, head of medical affairs for biopharmaceuticals, and Hillel Cohen, executive director of scientific affairs.

Negative Outcomes ‘Not Supported By Facts’

While the article claimed that the nature of biosimilars meant that they were not structurally identical to the original biologic and that “these differences … raise the potential for negative outcomes, such as loss of efficacy (including by increasing the risk of immunogenicity) and the emergence or worsening of adverse events,” Bourdage said this was “purely speculative and not supported by facts.”

“All biologics are produced from living organisms, which means that every biologic – whether reference medicine or biosimilar – is subject to inherent variability both of the biologic system itself and of the manufacturing process,” Bourdage pointed out, including within a given batch and between different batches of the same biologic. “These subtle differences are normal, expected and tightly controlled to ensure that safety, efficacy and quality is maintained.”

Citing the stringent approval requirements of the European Medicines Agency and US Food and Drug Administration, he pointed out that “a biosimilar has to match the reference biologic in terms of safety, efficacy and quality” and there “cannot be any clinically meaningful difference between the reference medicine and biosimilar.”

“Based on extensive data and evidence that is available and has been published, switching has no impact on efficacy, safety or immunogenicity,” Bourdage insisted. “All of the many studies published to date show that there is no increase in immunogenicity of biosimilars or other adverse events when compared to their reference medicines.”

No New Safety Events Linked To Biosimilars

Turning to the article’s claim that “one reason for treatment failures after switching is tolerability issues and the emergence of new or worsening adverse events, potentially caused by unanticipated differences in safety between the two products,” Bourdage said it was an “undisputed fact that in the 14+ years that biosimilars have been marketed, there have been no reports of new safety events observed with a biosimilar that were not already known from the reference medicine, nor have there been reports of higher levels of adverse events after administration of biosimilars.”

“A biosimilar is just as safe as its reference medicine,” he insisted. “The quality standards for biosimilars are identical to those applied to the reference medicine and, as a result, patients and their healthcare professionals can expect equivalent efficacy and comparable safety and immunogenicity.”

While the article authors had dismissed the “nocebo” effect – a perceived negative effect of medical treatment induced by patients’ expectations – as a potential mitigating factor based on a claim that the data was not sufficiently robust, Bourdage insisted that the nocebo effect was “a healthcare-wide issue” that can “lower quality of life, negatively affect treatment adherence rates, and contribute to perceived adverse events.”

This issue should be addressed by patient and physician education mitigation strategies for patients treated with biosimilars, he suggested. “Otherwise it has the potential to needlessly limit cost savings from and access to biosimilars.”  (Also see "Communication Needed To Avoid Biosimilar ‘Nocebo’ Effect" - Generics Bulletin, 17 Jul, 2020.)

Mounting Evidence Supports Switching

In response to a claim that “no definite conclusions can be drawn” about the potential risks of biosimilar-to-biosimilar switches, Bourdage insisted there was “growing evidence in the field of biosimilars-to-biosimilars switching,” with published studies detecting “no safety or effectiveness concerns.”

“Several large healthcare systems – e.g. Denmark; Kaiser Permanente, California, US – have switched large numbers of patients from one biosimilar to another, with no reports of negative impact on disease control, and no major safety events observed,” he remarked.

“In highly regulated systems/markets, biosimilar medicines are developed to match their reference biologic and are approved on the basis that they have no clinically meaningful differences. As a consequence, under the guidance of a physician, a patient can be switched to a biosimilar medicine, back to the reference medicine and – we at Novartis and Sandoz believe – from one biosimilar medicine to another.”

And finally, Bourdage countered the article’s claim that most global, regional, and national medical societies were urging caution on so-called “non-medical switching” and may not be in favor of multiple switches.

“Over the last year, more and more medical societies are supporting biosimilars and switching from a reference medicine to a biosimilar,” Bourdage observed.

“One such example is the “consensus-based recommendations for the use of biosimilars to treat rheumatological diseases” based on input from an expert group of specialists in rheumatology, dermatology and gastroenterology; pharmacologists; patients and a regulator from ten countries. All parties came to the conclusion that there is a robust body of evidence that supports the use of biosimilars.”

Bourdage also pointed to a 2019 publication by Medicines for Europe that listed a number of medical societies, pharmacist and patient organizations, EU regulators, national authorities, regulators and other government institutions that “all support switching.”

Industry Must Call Out ‘Alternative Facts’

Bourdage insisted that misleading claims and misinformation necessitated a vigilant response from the biosimilars industry. “With my incredulity building each time I turned the page, I finished with just one thought in mind: deliberate or otherwise, this sort of misinformation cries out for a public response,” he said of the Advances in Therapy article.

“Falsehoods, disparagement and misleading statements need to be called out for what they are – particularly when they risk jeopardizing public trust in critical medicines, with nearly 15 years of clinical practice confirming the safety and efficacy of biosimilars.”

“We cannot let misinformation undermine the facts and run the risk that biosimilars are not broadly adopted, hindering their potential to help millions of patients and healthcare systems worldwide,” Bourdage said.

Drawing parallels with “the persistent efforts to undermine the credibility of generic medicines in the early days of that industry,” he pointed out that “those efforts eventually failed – generics today represent 90% of US prescription medicines by volume – and I am confident that the “biosimilar information battle” will end the same way.”

“Whenever you see misinformation, whenever you see or read someone attempting to discredit biosimilars by the use of “alternative facts”: call them out, don’t be silent,” he urged. “We cannot afford to let silence, or apathy, risk the sustainability of our healthcare systems and damage the credibility of science.”

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