Pfizer petitions FDA to clamp down on biosimilar 'scare tactics'

Pfizer is calling for the FDA to issue guidance on what originator companies can say about cheaper biosimilars of their products, and prevent them using “scare tactics” to keep doctors prescribing more expensive original drugs.

A citizen’s petition by Pfizer asks the FDA to ensure “truthful and non-misleading communications” by pharma about safety and effectiveness of biosimilars.

Pfizer's petition comes ahead of a public hearing held by the FDA over access to biosimilars, which have the potential to save billions of dollars in healthcare costs.

Pfizer has recently got its Retacrit biosimilar of Amgen’s Epogen (epoetin alfa) red blood cell booster approved in the US.

It also has a biosimilar to Amgen’s white blood cell booster Neupogen (filgrastim) approved, in both cases for all indications of the reference products.

Pfizer has also partnered with South Korea’s Celltrion in the US to market Inflectra, a biosimilar of Johnson & Johnson’s Remicade (infliximab).

With other biosimilars in its pipeline, Pfizer said it is “highly supportive” of these drugs, which are near-copies of originator drugs, which have been shown to be just as safe and effective through a rigorous series of trials and analyses.

Thanks to faster development pathways in the US and EU, biosimilars are slightly cheaper to develop than the original drugs, but manufacturers still have to start from scratch and develop their own version of these highly complex proteins and antibodies.

Pfizer noted in its petition that the FDA introduced its biosimilars legislation in 2009, and the first drug approval using the pathway was in 2015.

The US has been lagging behind Europe – which approved its first biosimilar as long ago as 2006.

But this is not the only reason for the slow uptake of biosimilars in the US. According to Pfizer “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.”

In Europe, there is “far greater market acceptance” of biosimilars, where payers are more keen to adopt them.

Although the FDA is not able to decide payers’ reimbursement policies, it can influence them by ensuring there is no dissemination of false or misleading information by originator companies, Pfizer said.