Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen.

Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody.

But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the reference product. This means that while Inflectra or Renflexis can be prescribed for the same indications as Remicade, they cannot be substituted at the pharmacy level without the involvement of a physician or clinical decision maker.

And according to president of Janssen Immunology Scott White, this lack of interchangeability is keeping sales erosion of Remicade to a minimum.

“It is a competitive marketplace and we are competing on the basis of value and price,” he told delegates at the Goldman Sachs 39th Annual Global Healthcare Conference on June 12.

“There hasn’t been an infliximab molecule yet that’s been approved for interchangeability. And as a result, these products are all competing in the same space that Remicade is. So, it’s really an open market competition.”

Interchangeability Guidance

Sandoz Switching Study

White may have been alluding to Sandoz’s infliximab biosimilar candidate Zessly. The Novartis division has just presented data from a switching study showing there were no clinically-meaningful differences in terms of safety, efficacy and immunogenicity between patients with rheumatoid arthritis remaining on Sandoz infliximab and reference infliximab.

“The same results were found when patients on reference infliximab were blindly re-randomized to switch to Sandoz infliximab or remained on reference therapy,” the firm said.

The FDA has draft guidance available for industry (published in January 2017) asking for switching studies from biosimilar developers, but White said he is only aware of one infliximab molecule under early development pursuing an interchangeability label.

“I am not really sure about how the market is going to respond to [an interchangeable infliximab]. What I do know is how the market is currently responding. And the reason why the market is responding the way it is: number one, we are competing; and number two, Remicade has a well established profile in this market.”

He continued: “We have 20 years of experience in the space, 16 indications, a wealth of evidence and value and we continue to generate data for Remicade. As a result of that, a lot of our customers and patients in the market have a lot a high degree of trust and familiarity with the product, like with any biologic you need to establish yourselves in the marketplace in order to generate the trust and familiarity and comfort and through that, you drive adoption and growth.”

Europe

In Europe, infliximab biosimilars have been available for several years. The biosimilar market share after the first few months of launch were as much as 50% in Denmark, and in some countries Remicade sales have essentially been wiped out by biosimilar discounts and competitive tenders.

Interchangeability has a slightly different definition in the region, but each European Union member state has its own policy on physician-led switching. Specific positioning statements can be found here.

MSD (known as Merck & Co. in North America) is the MAA market authorization holder for Remicade in Europe. In 2012 – pre-infliximab biosimilars – the firm saw sales of over US$2 billion. In 2017, Remicade sales totaled $837 million.

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