No US Remicade biosimilar until at least October

Pulling in sales of $1.78 billion per quarter, Johnson & Johnson’s inflammatory diseases drug Remicade (infliximab) is still the jewel in the crown of the company’s pharma business.

But it’s unclear how long this will last, investors heard, as the company fights off competition in courts from Pfizer, which has a cheaper near-copy approved and ready to hit the US market where most of Remicade’s sales are based.

The picture became slightly clearer today, though, after the company said that Pfizer’s drug – developed by South Korea’s Celltrion – could hit the market in October.

In a conference call with investors following its Q2 results, chief financial officer Dominic Caruso maintained the same position as the last quarter, saying J&J had not factored in a competitor to Remicade into guidance.

But Caruso said litigation involving other biosimilars suggested that a 180 day post-approval waiting period, required under US laws before marketing of a biologic competitor, will expire in October.

In a case earlier this month, the US Court of Appeals for the Federal Circuit affirmed an injunction that keeps Apotex’s biosimilar of Amgen’s Neulasta (pegfilgrastim) off the market for 180 days after approval.

Caruso said the period for the Remicade biosimilar ends early in October and there can be no launch before that.

He added: “We will be vigorously defending our patent. Whether or not a biosimilar launch happens is not clear and we have not incorporated it into our estimates.”

Marketed outside of the US by MSD, Remicade sales have slumped in Europe because of biosimilar competition.

The FDA is also reviewing another biosimilar infliximab from Samsung Bioepis. It is also reviewing Amgen’s biosimilar of AbbVie’s Humira (adalimumab), which has similar uses to Remicade and is the world’s biggest selling drug. Around 60% of its $14 billion sales last year were in the US.

Total Q2 sales for J&J were $18.5 billion, up 3.9% compared with the corresponding period last year.

J&J raised its sales forecast for 2016 to a range from $71.5 billion to $72.2 billion, from $71.2 billion to $71.9 billion previously estimated.

Global pharmaceutical sales rose 8.9% to $8.6 billion, boosted by higher demand for cancer drug Imbruvica and blood thinner, Xarelto.


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