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Remicade safe from biosimilar competition this year, says J&J

Will defend the blockbuster’s US patents should Celltrion's Inflectra launch in 2016
Johnson & Johnson

Johnson & Johnson does not expect any biosimilar competition to its top product Remicade in the US this year, according to the firm's chief financial officer Dominic Caruso.

The comments come in the wake of the approval of Celltrion's Inflectra version of arthritis and immunological disease treatment Remicade (infliximab) by the FDA earlier this month, and speculation over a possible launch date for the biosimilar in the US.

"We don't expect biosimilar competition in 2016," Caruso said yesterday. "We have several patents that we intend to defend," he added, citing a US patent that extends to 2018 and another that goes out to 2027.

Celltrion has indicated it intends to launch in the US within six months, suggesting it is prepared to risk a legal challenge which could lead to an injunction on sales and potentially damages.

Remicade is J&J's biggest-selling drug and the third biggest selling pharmaceutical product in the world in 2014 - bringing in $10.2bn worldwide - with a large proportion of that total coming from the US market.

In Europe - where Remicade is marketed by MSD - the product has been facing direct competition since biosimilar versions were launched in 2014/2015. Last year, MSD reported that sales of the drug fell 24% to $1.8bn as competition drove down pricing.

Regardless, Caruso said that J&J's immunology franchise remains strong thanks to newer entrants such as Stelara (ustekinumab) and Simponi (golimumab) and with 10 new products filed with blockbuster potential the company is "very comfortable with the growth outlook for the pharmaceutical business regardless of the outcome of any Remicade biosimilar".

The remarks - made during J&J's first quarter results call - also indicate that J&J has not factored in biosimilar competition to Remicade in the US in its forecasts for 2016, which are that sales will reach $71.2bn-71.9bn with earnings of $6.53-6.68 per share.

J&J reported sales of $17.5bn in the first quarter - just about flat on the same period last year - with the pharmaceutical division rising 5.9% to $8.2bn thanks to in no small part to Remicade, which grew 11% to $1.78bn overall.

Simponi grew 30% to $390m in the quarter, while psoriasis therapy Stelara was up 34% to $735m. Other big performers for J&J were novel oral anticoagulant Xarelto (rivaroxaban) - up 38.6% to $567m - and leukaemia drug Imbruvica (ibrutinib) which saw sales more than double to $261m.

On the downside, hepatitis C therapy Olysio/Sovriad (simeprevir) continued its decline in the face of strong competition in the marketplace from Gilead and AbbVie, falling 86% to just $32m in the quarter.

Article by
Phil Taylor

20th April 2016

From: Sales

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