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Janssen Questions Literature Review on Biosimilar Switching Studies as Authors Defend it

Posted 22 May 2018 | By Zachary Brennan 

Janssen Questions Literature Review on Biosimilar Switching Studies as Authors Defend it

Three employees of Johnson & Johnson’s Janssen Pharmaceuticals, which has not publicly disclosed that it is developing any biosimilars, urged caution Tuesday on a literature review of biosimilar switching studies and said additional studies are necessary, though authors of the review also pushed back.

The letter to editor from Janssen’s Antonio Pires, integrated evidence team leader, Kavitha Goyal, senior director for Remicade development, and Andrew Greenspan, VP of medical affairs, follow a push from their parent company to protect its multi-billion dollar biologic Remicade (infliximab) from further competition.

Pfizer in December won approval for its second Remicade biosimilar, and Pfizer and J&J are locked in a legal debate as Pfizer claims “J&J's exclusionary plan has been remarkably effective at stifling competition.”

Switching

In March, a literature review published in Drugs found that data collected to date suggest that switching from a reference medicine to a biosimilar “is not inherently dangerous, and that patients, healthcare professionals, and the public should not assume that it is problematic.”

But the Janssen authors took issue with this conclusion in their letter and wrote: “We believe that the lack of comprehensive and systematic inclusion of relevant studies, appropriate weighting to reflect strength of evidence, and the combining of results across drugs, diseases, and type of studies, challenge the conclusion reached.”

They also conceded that although randomized, controlled trial data have demonstrated biosimilarity between biosimilars and their innovators, additional trials to gauge switching from innovator to a biosimilar may help.

However, the authors of the literature review said such additional studies are not necessary.

In defense of their review, the authors wrote, “It is incorrect to presume that there may be a problem with switching and that further study is necessary, or to impose a data burden on biosimilars not applied to other biologics, especially when there is no credible basis for such a request. A total of 90 studies with 14,225 patients is larger and provides stronger evidence than any individual study could be expected to provide. We therefore stand by our original conclusion that the extensive data collected to date show that the act of switching from a reference medicine to a biosimilar is not inherently dangerous, and that patients, healthcare professionals, and the public should not assume that it is problematic.”

Categories: Regulatory News

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