For the full year, J&J reported US sales of its autoimmune monoclonal antibody treatment Remicade of $4.45bn (€4.14bn), an 8.7% increase on 2015 sales.
But 2017 will see the firm compete with Pfizer, which launched its infliximab biosimilar – Inflectra, developed with Korean firm Celltrion – in the US late November at a 15% discount.
No impact yet
Despite this, the firm said in a conference call yesterday it is yet to have “observed any significant impact to-date” from the product and does not expect too much erosion over the next twelve months.
“We are not calling out any particular impact to Remicade,” CFO Dominic Caruso told investors. “We are going to see some slower growth throughout many of the pharma brands that have done exceptionally well up to this point.
“I just remind you that, we had a very significant impact with hepatitis C, not too many years ago and we did call that out, because that was very significant,” he continued, referring to the firm’s HCV products – including Olysio (simeprevir) – sales of which were essentially wiped-out due to the entrance of competitive products such as Gilead’s Sovaldi (sofosbuvir).
10-15%
“The impact to Remicade biosimilars is nowhere near that level of impact.”
While he refused to give guidance for individual products, Caruso compared the upcoming US biosimilar impact to the erosion J&J’s marketing partner Merck & Co. has seen in Europe since the introduction of infliximab biosimilars in 2014.
“Merck had experienced two years of a biosimilar in Europe and they’ve retained 70% market share after two years,” he said.
“So it’s reasonable to assume 10% to 15% perhaps market share erosion in the first year. Of course, in Europe, it’s much more dramatic, because of the impact of the healthcare system there.”
In some European countries, infliximab biosimilars have, however, essentially wiped-out Remicade’s market share.
Pfizer – which is both a reference biologic and a biosimilar maker – has previously said that biosimilars will have an effect but not in the short-term, as patients gradually switch over and physicians and payers slowly become accustomed with the new products.
Meanwhile biosimilar uptake continues to be delayed by legal disputes, and J&J CEO Alex Gorsky said yesterday his firm “will continue to vigorously defend our patents on Remicade while remaining competitive against at-risk biosimilar entries given our long track record of efficacy and safety.”