No US competitor to big-selling Remicade this year - J&J


Johnson & Johnson (J&J) does not expect top-selling drug Remicade (infliximab) for inflammatory diseases to face US biosimilar competition in 2016, saying it expects to fend off a near-copy challenger in the courts.

Louise Mehrotra, vice president of investor relations at J&J, said that guidance for 2016 did not include effects of biosimilar competition to Remicade, adding that the company expected to block any challenge from Celltrion's near-copy rival, Inflectra, approved by the US Food and Drug Administration at the beginning of the month.

Mehrotra told a conference call with analysts: "We don't expect biosimilar competition in 2016. We have several patents to defend, including patent 471 which lasts until 2018 and another that lasts until 2027."

At stake are US Remicade sales of almost $1.8 billion in Q1, up from $1.6 billion in the previous Q1. Chief financial officer Dominic Caruso confirmed the company had received notice from Celltrion that the South Korean company plans to market a competitor within six months.

In Europe, where Remicade is marketed by MSD, heavy discounting after patent expiry just over a year ago has seen the biosimilar steal market share from the originator. Europe's CHMP has recommended a second Remicade biosimilar from Samsung Bioepis.

There will be no US generic competition to prostate cancer drug Zytiga, or schizophrenia drug Invega Sustenna, either, said Mehrotra. She noted the strength of J&J's immunology franchise, which includes Stelara and Symponi, saying that the company has several potential blockbusters in late-stage development.

J&J saw a strong performance in its pharma division thanks to psoriasis drug Stelara and blood thinner Xarelto.

The company's pharma division has now overtaken medical devices and consumer health products to become the New Jersey-based company's biggest division.

Pharmaceutical sales rose almost 6% to $8.2 billion, even factoring in the impact of currency headwinds. Sales across all divisions, including medical devices and consumer health, were up 6.9% to $17.5 billion, excluding divestitures, declining hepatitis C drug sales and acquisitions.

Roche, which has also announced Q1 results, benefited from increasing sales of its three key cancer drugs, Herceptin, Avastin and Rituxan, which account for a third of revenue. Sales grew 4% to $12.4 billion Swiss francs ($12.87 billion).

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European regulators back Samsung's Remicade biosimilar

19 April, 2016