2016: year of the US biosimilar approval

By Dan Stanton contact

- Last updated on GMT

Image: iStock/marekuliasz
Image: iStock/marekuliasz
With four biosimilars now approved in the US, the sector is growing in confidence says a BMI Research analyst.

If 2015 was the year biosimilars ‘landed in the US’​ through the launch of Zarxio - Sandoz' version of Amgen’s Neupogen (filgastrim) - then 2016 could be deemed the year of the second-wave approval.

Pfizer/Celltrion’s Remicade (infliximab) biosimilar Inflectra was given the thumbs up by the US Food and Drug Administration (FDA) in April​; Sandoz’ version of Enbrel (etanercept) was approved in August​; and the following month​ Amgen saw regulatory success for its version of AbbVie’s Humira (adalimumab), Amjevita.

“The US market has begun to open up as expected, but it is still very early days and there remains some way to go,”​ Ian Platts, pharmaceuticals markets analyst at BMI Research, told Biopharma-Reporter.com

Platts added: “Biosimilar approvals are progressing, but launching remains an issue, partly because there remains a lot of litigation which is testing out the finer points of the regulatory pathway.

“2016 could indeed be deemed the year of the biosimilar approval in the US rather than the year of launch.”

Upcoming launches

Pfizer announced in October​ it was ready to launch Inflectra late November, despite reference drugmaker Janssen saying it would be done “at-risk.”

The first batches were shipped to its US wholesalers on November 21, a spokesperson from the company told us, and is now available to patients.

Meanwhile, Amgen has said it does not expect to launch Amjevita in the US in the next year due to ongoing litigation with AbbVie. The earliest it could be launched is March 22, based on the 180-days notice from the date of approval biosimilar developers are obliged to give to reference drugmakers.

Clarification: The original article did not make it clear that Pfizer/Celltrion's Remicade biosimilar Inflectra has been launched in the US. 

Related topics: Markets & Regulations, Biosimilars

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