April 27, 2024

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[THE INVESTOR] South Korea’s biopharmaceutical firm Celltrion is expected to benefit from US health authority’s proposed new guidelines which will deem a biosimilar interchangeable with its original product when developers provide sufficient evidence to back up their similarities, experts said on Jan. 19.

Celltrion is hoping patients make the jump from Johnson & Johnson’s blockbuster Remicade to its biosimilar, which hit US pharmacy shelves in November last year, once its Remsima prove its interchangeability to the US Food and Drug Administration which issued the draft guidelines on Jan. 17.

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“The guidelines will enable biosimilar makers to expand their footing in the biopharmaceutical market in the long-term,” a researcher at Korea Pharmaceutical Manufacturers Association told The Investor.

Under the guidelines, the FDA expects that biosimilar developers will submit data and information from a switching study to prove their products are interchangeable with the reference drug.

If approved by the FDA, interchangeable biosimilars can be substituted for their reference product at the pharmacy without the prescribing doctor’s approval.

Remsima was found to have comparable efficacy and safety following a switch to the biosimilar infliximab from the reference product Remicade in an independent phase 4 study sponsored by the Norwegian government in Oct. 2016.

Lee Tae-young, an analyst at Meritz Securities said Celltrion may need additional clinical trials to confirm Remsima‘s interchangeability.

“But there seem to be no other biosimilar candidates (referencing Remicade) that have undergone clinical trial design such as switch studies that meet the requirement the FDA has suggested,” he said.

Interchangeability is seen as a major benefit to biosimilar developers like Celltrion which seek to gain larger market share from the original biological drug with cheaper prices.

But winning the designation will not be easy and will take time, the researcher said.

“They won’t see instant results as the conditions and proceedings for approval seem to be more detailed and complex than expected.”

The FDA will publish the final guidlines by end-March after the close of public comments period.

“If (the guidelines are) confirmed, it will be possible to administer Remsima to existing patients, which will have a positive impact on market share expansion in the US,” an official at Celltrion said.

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