Education is key to US biosimilar success – Pfizer

Like many pharma companies, Pfizer is attempting to eat into the sales of rivals with biosimilars – cheaper near copies of biological drugs that have begun to dominate the prescription medicines market.

Pfizer hopes to take on Johnson & Johnson (J&J) with its biosimilar of Remicade (infliximab) in the US, a blockbuster inflammatory diseases drug that generated $1.8 billion in sales revenue in the last quarter alone.

But a key issue is how to ensure doctors are willing to prescribe its cheaper near-copy of infliximab, known as Inflectra, after it is launched late next month.

The US regulator has ruled the drug cannot be substituted automatically by pharmacists, so doctors will have to make out new prescriptions if they want to switch their patients to the biosimilar.

J&J thinks that this will prevent the biosimilar taking market share, at least in the short term.

Pfizer said convincing doctors and patients to switch to biosimilars can still be a challenge. While it did not point fingers at any pharma rivals, Pfizer said there are still “misperceptions and confusion” about biosimilars, which require “continued education” of stakeholders.

This is where the NOR-SWITCH study comes in, conducted in Norway, one of the first countries to use Pfizer’s biosimilar, which was originally developed by South Korea’s Celltrion.

The study provides post-marketing clinical data reassuring doctors that it is safe to switch from the originator to biosimilar.

Javier Coindreau, vice president, global medical affairs at Pfizer, told pharmaphorum: “We cannot comment on the actions of other pharmaceutical companies. However, there continues to be misperceptions and confusion about biosimilars, requiring continued education across various stakeholders on the valuable role that biosimilars can play. Pfizer is committed to providing ongoing educational support for all relevant stakeholders as required.”

He added in the email interview: “The NOR-SWITCH study results are important, given they deliver outcomes from the first randomised controlled trial to compare the effect of switching to an infliximab monoclonal antibody biosimilar, Inflectra with continued treatment via the originator biologic.

“In the NOR-SWITCH study, similar frequencies of adverse events were demonstrated in patients undergoing a single switch from Remicade to originator infliximab combined with biosimilar infliximab compared to those remaining on originator therapy.”

Pfizer seemingly has no plans to change the FDA’s ruling on whether the drugs are interchangeable, even though J&J said last week that the lack of interchangeability will help fend off competition from the biosimilar.

Coindreau added: “It is Pfizer’s position that the decision to switch to a biosimilar should always be a clinical one, made by the treating doctor on an individual patient basis, supported by scientific evidence and with patient awareness. Pfizer believes in informed switch based upon evidence.”

Coindreau did not say why Pfizer takes this stance, even though it has data from the NOR-SWITCH study that backs switching to biosimilar infliximab. Unlike in Europe, the FDA does have the authority to rule that biosimilars can be interchanged.

Perhaps the reason is that as a gamekeeper turned poacher, Pfizer has to protect its own products in the same way as J&J protects Remicade.

Pfizer markets Amgen’s Enbrel (etanercept) in Europe, itself threatened by biosimilar competition, and may not want to take a stance that could undermine sales of its own product.

Assuming it can negotiate any legal issues raised by J&J, Pfizer is due to launch its biosimilar infliximab in late November in the US. MSD markets Remicade in Europe, where the biosimilar has been available for more than a year in major markets, and is beginning to impact sales of the originator.

Coindreau gave no further details about Pfizer’s goals in terms of US market share, and whether it would consider discounting the biosimilar further than the 15% already suggested by Pfizer when it announced the launch.

He said: “We believe competition will not only provide more choice for patients and doctors, but also help foster a competitive pricing environment. We cannot comment further on our commercial strategies.”

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