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Celltrion submits biosimilar Remicade for US approval

Drug is second to be assessed by FDA under biosimilars pathway
FDA headquarters White Oak

Celltrion's copy of Johnson & Johnson's autoimmune treatment Remicade is the second drug to be assessed for use in the US under the FDA's biosimilar approval pathway.

The regulator will take the next few months to review Celltrion's version of infliximab, which is to be marketed under the brand name Remsima, to determine if it is equivalent to J&J's product.

The decision means Celltrion is the first company to have a biosimilar version of a monoclonal antibody accepted for review in the US. It follows the FDA's decision last month to assess Novartis' version of Amgen's Neupogen (filgrastim), which became the first treatment to be accepted for review under the biosimilars pathway since its creation in 2009.

The quick succession of these decisions is important for the US, which has fallen behind other markets, such as South Korea and Europe, where biosimilars – copies of biological medicines – are already available.

Indeed Celltrion's version of infliximab is approved for use in more than 50 countries worldwide, including Canada, Japan and Europe, where it was approved in September last year as the first biosimilar monoclonal antibody available in the region.

The approval was an important one for the pharma industry as it opened the door to lower cost competition to big-selling monoclonal antibodies.

Regarding the drug's availability in the US, Celltrion said it anticipates obtaining US FDA approval within one year.

Once approved, Celltrion would still only be able to launch its biosimilar once J&J's patent on infliximab expired. This is currently set to be at the end of 2018, although Celltrion confirmed has launched a legal battle that challenges J&J's patents.

Celltrion said that the FDA's decision to review Remsima under the biosimilars oathway was “garnering interest” from biosimilar developers and healthcare providers.

“This is because the medical community is aware that the eventual approval of sales of biosimilars in the US market will signal an age where biosimilar monoclonal antibodies are globally recognised as innovative high quality biologics, with equivalency in both efficacy and safety to their originator products, available to patients in need at a more affordable price,” said the company.

Article by
Thomas Meek

14th August 2014

From: Sales



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