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The Korea Herald
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THE INVESTOR
April 13, 2024

Bio

Celltrion to complete switching studies of Remicade biosimilar in US this year: sources

  • PUBLISHED :April 25, 2017 - 16:43
  • UPDATED :April 26, 2017 - 08:42
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[THE INVESTOR] Celltrion and its retail partner Pfizer plan to complete switching studies of the Korean drug maker’s biosimilar Inflectra, known as Remsima in Europe, to demonstrate its interchangeability with the original drug Remicade by the end of this year, industry sources said on April 25.

Inflectra, referencing Johnson & Johnson’s blockbuster autoimmune disease treatment Remicade, made its US debut in November last year but sales are still lukewarm. 




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Sources say physicians are still reluctant to prescribe the first biosimilar over its original drug despite price benefits. Over the past months, the original drug’s market share dropped less than 3 percent.

“Once the switching studies are completed before the year-end, Inflectra will gain sales momentum next year,” a person familiar with Celltrion’s sales strategy said on the condition of anonymity.

The US Food and Drug Administration advises biosimilar developers to provide data from switching studies to ensure quality and safety of their drug but none of biosimilars approved in the US have met the requirements so far.

According to Symphony Health, a US pharmaceutical market data provider, some US$4.41 million worth of Inflectra was prescribed in the US in March, up 179 percent from US$1.58 million in February. Remicade’s US sales reached US$4.45 billion last year.

“Biosimilar sales usually make a ‘J-curve’ growth that means Inflectra could see some meaningful acceleration at some point,” the source said, citing the drug’s European success.

In a recent interview with The Investor, Celltrion’s co-CEO Kim Hyoung-ki said the company aims to take away 40 to 50 percent of Remicade’s market share in the US “very soon.”

By Park Han-na (hnpark@heraldcorp.com)

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