Pfizer Inc., which has been publicly complaining about impediments to biosimilar product sales for more than a year, is taking its case to the U.S. Food and Drug Administration.
The New York-based drugmaker has filed a citizen petition with the U.S. Food and Drug Administration requesting that the regulatory body take action against communications from rival pharmaceutical companies about Pfizer's biosimilars.
Among the companies mentioned in the document are Johnson & Johnson's Janssen Biotech Inc. unit and Amgen Inc., both drugmakers that market products with corresponding Pfizer biosimilars. All three are among the world's top 10 healthcare companies by market value.
Pfizer listed specific examples from each company across various media that it called "false and misleading representations" about biosimilars, which the FDA defines as biological products that are highly similar to and have no clinically meaningful differences from their corresponding marketed drugs. Biologic medicines are derived from living cells and are sometimes called large-molecule products.
The company said the communications are partly responsible for the fact that the use of its biosimilars in the U.S. has lagged expectations. In the case of Inflectra, a biosimilar of J&J's anti-inflammatory rheumatoid arthritis best-seller Remicade, 2017 worldwide sales reached only $419 million, whereas Remicade held the majority of the market at $6.32 billion in sales.
Pfizer is "potentially the biggest beneficiary of all biosimilar makers" and "stands to be a major beneficiary of the evolving biosimilar market," Credit Suisse analysts said in a note. Therefore, investing in market confidence is crucial as the company looks to cash in on the biosimilar field, they said.
Both J&J and Amgen have published material that Pfizer said is inconsistent with the approved definition of a biosimilar, misleading patients and physicians, according to the petition.
An April 2018 Twitter post from Amgen included in Pfizer's petition said: "Biologics or biosimilars? It's not just apples to apples. While biosimilars may be highly similar to their biologic reference products, there's still a chance that patients may react differently."
And a J&J brochure says, "[Y]ou may be asked to switch to a biosimilar that works in a similar way to Remicade," to which Pfizer replied that a biosimilar works not in a similar way, but in the same way as the original drug.
Pfizer said the statements "create undue confusion" about biosimilars and their effectiveness. The company requested that the FDA clarify its guidelines on communications when comparing a medicine to its corresponding biosimilar to avoid giving false impressions about safety and efficacy.
It's not the first biosimilar battle for these big companies. Remicade and Inflectra are at the center of an ongoing lawsuit filed by Pfizer against J&J. In September 2017, Pfizer accused Johnson & Johnson of signing exclusionary contracts with health insurers to the detriment of Inflectra. J&J denied any wrongdoing, but Credit Suisse analysts wrote that "this case will set an important precedent that will help determine how the biosimilar landscape will evolve in the U.S."
In support of biosimilars, President Donald Trump issued in May 2018 the "Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs," which tasks the FDA with improving "the availability, competitiveness, and adoption of biosimilars as affordable alternatives to branded biologics."
And in March 2018, FDA Commissioner Scott Gottlieb said at the America's Health Insurance Plans' National Health Policy Conference, "FDA is invested in making sure that the new biosimilar pathway works, and that we can help facilitate a robust market for these products. So, we take note when we see market practices that can reduce the incentive for sponsors to invest in the development of biosimilars in the first place."
Besides Inflectra, which was approved in Europe in 2015 and the U.S. in 2016, Pfizer's three other U.S.-approved biosimilars are from either J&J or Amgen, which makes both brand-name biologics and biosimilars. The first of those is Ixifi, which Pfizer chose not to launch to focus on marketing Inflectra.
The other two are both biosimilars of Amgen products: Retacrit mimics the anemia drug Epogen, and Nivestym is a version of Neupogen, which treats the blood disease neutropenia. Retacrit and Nivestym were approved in May and July of 2018, respectively.