Pfizer hits out at other companies over use of

Pfizer recently submitted a citizen petition calling on the FDA to issue guidance that will ensure companies use "truthful and non-misleading" communications regarding the safety and effectiveness of biosimilars compared to the originator products. In the petition, Pfizer criticised other drugmakers, including Amgen and Johnson & Johnson, for employing "scare tactics" that have played a significant part in limiting the uptake of biosimilars in the US.

In May, the FDA approved Pfizer's Retacrit (epoetin alfa-epbx) as a biosimilar version of Amgen's Epogen (epoetin alfa) and Johnson & Johnson's Procrit (epoetin alfa), with the company more recently gaining clearance in the US for Nivestym (filgrastim-aafi) as a biosimilar version of Amgen's Neupogen (filgrastim). Pfizer also markets Celltrion's Inflectra (infliximab-dyyb), which was cleared by the FDA in 2016 as a biosimilar version of Johnson & Johnson's and Merck & Co.'s Remicade (infliximab).

Despite being launched at a 15-percent discount to the wholesale acquisition cost of Remicade, Inflectra has struggled to gain traction in the US. Last year, Pfizer filed a lawsuit accusing Johnson & Johnson of using "anticompetitive" practices, claiming that the latter's "systematic efforts to maintain its monopoly…by inappropriately excluding biosimilar competitors violates federal antitrust laws."

In its citizen petition, Pfizer noted that "market acceptance [of biosimilars] has been much slower than anticipated." The drugmaker added "we believe that a major factor contributing to this slow uptake is a lack of market confidence in biosimilars resulting from the efforts of certain reference product sponsors to disseminate false and misleading information that casts doubt about the safety and efficacy of biosimilars in the minds of patients and prescribers."

Specifically, Pfizer said that in a patient brochure for Remicade, Johnson & Johnson fails to mention that an approved biosimilar has no clinically meaningful differences from the reference product. In the brochure, Pfizer noted that Johnson & Johnson suggests that biosimilars work in "a similar way" to Remicade, despite US legislation stating that a biosimilar is highly similar to the reference product, but has the same mechanism of action, so works in the same way.

Pfizer also highlighted Johnson & Johnson's focus on interchangeability, which the former alleges acts to "sow doubt and confusion about biosimilars." Pfizer said that despite Inflectra not being approved as interchangeable, study results have shown that switching patients with Crohn's disease to Inflectra from Remicade led to comparable efficacy, safety and tolerability to treatment with Johnson & Johnson's product over a 24 week period. Pfizer claims that "by emphasising that the Inflectra product is not interchangeable, the manufacturer is clearly attempting to mislead patients."

Further, Pfizer also singled out misleading information on a website from Roche's Genentech unit, as well as a tweet from Amgen. Pfizer said that it believes that "truthful and non-misleading communications about the safety and efficacy of biosimilars are important to increasing uptake of biosimilars, and securing patient and healthcare provider acceptance."

The citizen petition comes shortly after the FDA unveiled plans designed to facilitate the development, approval and market entry of biosimilars in the US. At the time, FDA Commissioner Scott Gottlieb said "we're not going to play regulatory Whac-A-Mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We're not going to wait a decade or more for robust biosimilar competition to emerge."

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