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Novartis Submits Comments to FDA in Support of Pfizer's Citizen Petition


This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Pfizer’s citizen petition called on the agency to issue guidance clarifying how drug sponsors may communicate about biosimilars, alleging that misinformation communicated to patients, payers, and prescribers, is hindering the growth of the US biosimilar market.

In its comment letter, Novartis explained that it supports the recent efforts from the FDA and HHS to increase the use of biosimilars, specifically, releasing the Biosimilar Action Plan, holding a public hearing in September 2018, and initiating dialogue around key biosimilar topics through the American Patients First blueprint. However, Novartis notes that it believes the FDA and HHS “could do more to incentivize the use of biosimilars while still ensuring access to and development of novel biological products.”

The letter goes on to discuss the importance of accurate information about biosimilars being disseminated to the public, sharing in Pfizer’s concern, and specifically calling on the FDA and HHS to address multiple “misinformation campaigns” that it believes are hurting biosimilar uptake.

Novartis states that the following misinformation campaigns do not provide balanced information about biosimilar products “but rather infer potential risks and aim at casting doubts about their safety or efficacy”:

  • A Letter to the Editor, published by Vancouver Sun, states that “Biosimilars are similar, but not identical to the originator biologic and they aren’t interchangeable. In most cases, they aren’t made by the same company, haven’t used the same living cells, and may not have employed the same manufacturing process.”
  • On the Patients for Biologics Safety & Access website, the organization lists concerns about biosimilars, saying that “a slight variation in the manufacturing can result in serious, life-threatening adverse events in our patients.”
  • Janssen’s “Finely Tuned” website for brand-name Remicade states that “Once you and your doctor fine tune your treatment, you want to stay on what is right for you.”

The letter also cited results seen in a recent report from FirstWord Pharma that found that 33% of respondents said they had heard negative feedback about biosimilars. “There appears to be a particular strategy among some originator companies to openly question the quality of biosimilars, in addition to negative discussion about their efficacy and safety,” concluded the report.

In order to address these issues, Novartis agreed with Pfizer on the need for additional FDA action and oversight “to help ensure a truthful environment exists within which healthcare providers and patients can make treatment decisions without harmful misinformation about biosimilars.”

Specifically, Novartis recommends that the FDA take the following actions: partner with the Federal Trade Commissioner to identify and address these campaigns, issue correspondence directing these organizations to stop publishing misinformation campaigns, establish a public list of which companies or organizations are conducting such campaigns, and enhance educational outreach efforts to contest the campaigns.

Finally, Novartis encouraged the FDA to publish a “Facts About Biosimilars” page on its website to address the most common misinformation and misunderstood elements about biosimilars. In order to deliver the content to a broader audience, Novartis suggested that the FDA work with and leverage relationships with healthcare provider organizations as well as patient advocacy organizations to ensure their members have access to it.

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