Johnson & Johnson’s Remicade continues to hold 92% of the market by volume three years since infliximab biosimilars arrived in the US.

Johnson & Johnson (J&J) opened the first quarter 2019 reporting season this week by announcing an 8% year-on-year growth in its pharmaceutical’s division to $10.2 billion (€9 billion).

For its immunosuppressive monoclonal antibody Remicade (infliximab), US sales – representing 70% of global sales for the firm – fell 15.5% compared to the same period last year, to $774 million. Worldwide sales stood at $1.1 billion, a 21% drop year-on-year.

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Management attributed the fall to the impact of biosimilar competition and alternative mechanisms of action.

The US Food and Drug Administration (FDA) approved its first infliximab biosimilar three years ago this month in the form of Pfizer’s Inflectra. Since then, an infliximab biosimilar from Merck/Samsung Bioepis has been launched, and a second infliximab from Pfizer has received approval.

But rather than taking a slice of the infliximab market, J&J still dominates with 92% of the markets share by volume having reduced its prices and offered higher discounts to ward off direct competition.

“So we are continuing to see erosion of Remicade, as expected,” EVP and worldwide chair of Pharmaceuticals at J&J Jennifer Taubert said in a conference call.

“But if we take a look, our team has been really competing in the marketplace to try to ensure that patients who would like to stay on Remicade have the access and the availability to do so. And right now, we’ve been able to retain about 92% of the volume share for infliximab, but obviously, albeit at a lower and a very competitive price in the market.”

Interchangeability hurdle

The 92% share has dropped by one percentage point since the last quarterly report, indicating biosimilars are very slowly nibbling away at the reference biologic.

However, one of the major hurdles to biosimilar competition in the US is the fact that neither Inflectra nor Merck’s Renflexis have been deemed interchangeable. This means that while they can be prescribed for the same indications as Remicade, they cannot be substituted at the pharmacy level without the involvement of a physician.

In June 2018, J&J management noted the lack of interchangeable biosimilars keeps Remicade sales erosion at a minimum.

In January 2017, the FDA released long-awaited draft guidelines on interchangeability, recommending firms undertake ‘switching studies’ to show whether alternating between a biosimilar and its reference product impacts the safety or efficacy of the treatment.

However, payors and biosimilar developers have argued such studies – which are not necessary in Europe – restrict the uptake of biosimilar products.