Pfizer Execs Underscore the Need for a Level Playing Field for Biosimilars

In a press briefing today at Pfizer’s headquarters in New York, New York, Pfizer’s executives reviewed their progress with biosimilars to date and underscored the need for a level playing field if biosimilars are to compete with brand-name biologics in the United States.

Richard Blackburn, global president for Europe, Africa, the Middle East, and biosimilars for Pfizer Essential Health, said that projections of biosimilars’ eventual share of the global biologics market could equate to about $40 billion per year in sales—a figure he called “too big to ignore.”

Blackburn added that sales of Pfizer’s biosimilar infliximab, Inflectra, grew by 66% last year, earning the company $420 million. Despite that that progress, and “notwithstanding our confidence and our optimism about the future…things won’t happen automatically” to spur biosimilar uptake in the United States. Blackburn warned that stakeholders will have to align on their priorities. There remains a need for education to help clear up “misinformation” about biosimilars, as well as a need for fair and equal market access.

There will also have to be a consensus about what constitutes reasonable pricing for a biosimilar product. “While pricing is at the heart of the biosimilars issues, and cost savings are kind of the point here,” he said, the same kinds of savings provided by generic drugs “will not be achievable” with biosimilars given the costs associated with development. “If that’s what stakeholders strive for, then we will find that companies are unable to make money, and we won’t see successive waves of new compounds coming to market over the next 20-odd years.”

As far as savings from Inflectra are concerned, Pfizer said that its second-quarter average sales price (ASP) for Inflectra is $650, an approximate 17% discount to Remicade’s $786 ASP. That’s progress from the approximate 13% discount in the first quarter of the year, and an approximate 10% discount in the final quarter of 2017. Discounts provided to hospitals and clinics for the drug are generally higher, in the range of 25% to 40%.

According to John Kennedy, general manager of US biosimilars for Pfizer Essential Health, in the last quarter of 2017, Inflectra had a 5.6% share of infliximab market by volume. About half of that share came from highly integrated systems, such as the United States Department of Veterans Affairs.

“In general, these highly integrated systems have been able to prioritize sustainable cost savings over short-term rebates,” said Kennedy.

However, outside these systems, Kennedy said, contracts struck between payers and the reference infliximab’s (Remicade) sponsor, Johnson & Johnson (J&J), have been creating hurdles for Inflectra in the marketplace. “Anticompetitive practices, like J&J’s exclusionary contracting, need to be stopped,” he said.

Blackburn added that “the extent to which we’ve seen exclusionary practices in the [United States] probably has been the thing that … we’ve had to deal with perhaps more than we anticipated.”

Pfizer has not yet seen the contracts used by J&J, Eric Aaronson, JD, senior vice president and chief counsel for Pfizer Essential Health, made clear, but Pfizer’s position on J&J’s contracting—as well as on its purported bundling of products—is informed by discussions with payers, and led to its lawsuit against the Remicade maker in 2017.

J&J has filed a motion to dismiss that lawsuit, and both parties are awaiting the court’s decision in the matter. However, according to Aaronson, the motion to dismiss did not deny any of Pfizer’s allegations. “Take whatever you want from that,” said Aaronson.

Looking to the future, Amrit Ray, MD, global president of research and development for Pfizer Essential Health, highlighted a pipeline of 7 late-stage biosimilar candidates, comprising adalimumab, trastuzumab, rituximab, bevacizumab, epoetin alfa, filgrastim, and pegfilgrastim, and said that Pfizer has 5 other proposed biosimilars in preclinical development.