Pfizer set for US launch of Remicade biosimilar

Pfizer is to launch its biosimilar of Johnson & Johnson’s blockbuster inflammatory diseases drug Remicade next month in the US.

This is only the second biosimilar drug to be launched in the US, and the first monoclonal antibody biosimilar to be launched there. Biosimilars are cheaper near-copies of biological drugs.

Launched in major European markets early last year, the biosimilar has already made a dent in Remicade’s sales in some countries, but uptake has been patchy.

The launch comes a few weeks later than predicted by J&J, which said in a Q2 results conference that Pfizer would have to wait six months to launch the drug under US laws, following patent expiry earlier this year.

Pfizer has the US rights to Inflectra, which was originally developed by South Korea’s Celltrion and plans to launch it late next month. It is approved in the same indications as the original drug, including rheumatoid arthritis.

Sales of Remicade in Q2 were in excess of $1.2 billion, with a further $500 million in exports, and Pfizer’s competitor will be priced at a 15% discount to the originator.

It remains to be seen whether Pfizer can convince doctors to prescribe the biosimilar. In Europe, one of the major barriers to use has been reassuring physicians that the drug is safe to use, despite the rigorous regulatory system in place.

Diem Nguyen, regional president North America, Pfizer Essential Health Business, said: “We are proud of our global leadership in biosimilars, and will continue our efforts to advance a sustainable, competitive marketplace for these therapies to deliver a high quality, consistent supply of product and long-term savings and value for patients and physicians.”

The US is lagging behind Europe in biosimilar launches. The first biosimilar was approved in Europe 10 years ago, and more than 20 have been approved since then.

The first biosimilar to hit the US market was Sandoz’s Zarzio, a biosimilar of Amgen’s white blood cell booster, Neupogen (filgrastim), which was approved last year.

However the US and EU regulators are now working close together and share data to reduce the number of trials required for approval.

According to an IMS Health report earlier this year, biosimilars could save $110 billion for the US and major EU health systems by 2020.

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