Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior.
In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.”
The firm continued: “Dissemination of false or misleading information about the safety or efficacy of biosimilars, whether to patients and prescribers or directly to payers, has the potential to affect payer decisions about biosimilar reimbursement, as well as patient and healthcare professional confidence in biosimilars.”
Therefore, the firm has requested that the US Food and Drug Administration (FDA) issue guidance to ensure “truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(s),” despite this being out of the Agency’s remit.
The FDA has approved only twelve biosimilar medicines, and only a handful of those have reached the market. Initial sales have also been disappointing.
A third of the US approvals are marketed by Pfizer: Two versions of J&J’s Remicade (infliximab), and versions of Amgen’s Epogen and Neupogen. The firm has a further three biosimilars in Phase III trials, including versions of Roche/Genentech bestsellers Avastin (bevacizumab) and Rituxan (rituximab).
Accusations
Within the petition, Pfizer cited examples by reference biologic makers of spreading false and misleading information about biosimilars, through the creation of “reference product sponsor-created physician- and patient-directed materials that mischaracterize important elements of the biosimilar criteria and create doubt and confusion about the safety and efficacy of biosimilars.”
Genentech’s ‘Examine Biosimilars’ website was one example Pfizer said failed to state that an approved biosimilar must have no clinically meaningful differences from the reference product.
Genentech’s parent company Roche told us it is reviewing the petition, with spokesperson Anja von Treskow adding: “We have long-supported the FDA’s efforts to implement a science-based pathway for the approval of biosimilars.”
Highly similar, highly complex
Pfizer also hit out at J&J subsidiary Janssen Biotech, which markets Remicade, specifically in a patient brochure entitled, ‘Finely Tuned – Your Treatment, Your Choice.’ Pfizer said the firm deliberately confused the fact that a biosimilar has the same mechanism of action as its reference biologic, meaning that a biosimilar works in the same way.
But Linda Davis, a spokesperson from Janssen Immunology, told BioProcess Insider: “Remicade is a complex biologic medicine that cannot be copied exactly, and biosimilars are highly similar but not the same as the innovator.
“Approval as a biosimilar alone does not mean the product will have the same efficacy and safety in any given patient,” she continued, adding that “according to the FDA, interchangeability has additional requirements of approval compared to biosimilarity and to date there are no approved interchangeable biosimilars to Remicade.”
She also told us in response to Pfizer’s allegations that: “The treatment decision resides between a physician and a patient; the Finely Tuned campaign encourages stable patients taking biologics to talk with their doctors and to have a voice in their own treatment decisions.”
The proprietary name game
Amgen, a company which itself has a strong biosimilar portfolio, was accused of similar messaging in a YouTube video about the importance of naming conventions and identifiers for biosimilars.
The video says switching biologics “carries risks, given that no two biologic medicines are identical, and thus can behave differently in the body. Switching drugs is not a good idea if your medicine is working for you,” something Pfizer said implies that switching generally is risky, and undermines the BPCIA and FDA’s efforts to promote the use of biosimilars
In response, Amgen told this publication it “is committed to educational communication of factual, balanced information regarding biosimilars and their use, and believe such communications help build the confidence necessary to ensure biosimilar uptake.”
The firm added it has developed “scientifically accurate materials to help foster understanding of, and interest and confidence in, the adoption and utilization of biosimilars,” citing as an example an educational campaign to educate physicians and pharmacists who will prescribe and dispense biological products (including biosimilars) on the importance and appropriate use of the suffix, following the FDA guidance on nonproprietary naming.
“It’s important to note Pfizer’s comments to the FDA draft guidance on nonproprietary naming, noting that they explicitly supported the use of distinguishable suffixes to facilitate pharmacovigilance and inadvertent substitution,” Amgen said.