April 24, 2024
Bio
Samsung’s Remicade biosimilar launch in US may be advanced
[THE INVESTOR] A recent court ruling could advance the US launch of Samsung Bioepis’ Renflexis, biosimilar version of Johnson & Johnson’s blockbuster autoimmune monoclonal antibody treatment Remicade, sources said on June 14.
The US Supreme Court has ruled that biosimilar developers can sell their drugs immediately after gaining approval from the Food and Drug Administration, instead of the current practice of giving a six-month notice to the original drug makers.
Sources say the ruling could be a boon for Reflexis, scheduled to make its crucial US debut later this year.
Samsung Bioepis had planned to launch the drug in October following FDA approval in April. But sources say Merck, the US marketing partner, could move up the schedule.
“The release date of Renflexis will be determined by Merck which holds the US marketing license, and there is a possibility that the release will be advanced following the court’s decision,” a source said on condition of anonymity.
“Samsung has also been paying keen attention to the ruling to catch up with Celltrion,” he added, citing Inflectra, another Remicade biosimilar that hit the US market in November last year through its retail partner Pfizer.
Renflexis’ early arrival could mean a loss of billions of dollars for the original Remicade amid the already heated competition with cheaper biosimilar rivals. Remicade earns US$4.45 billion in the US alone.
On June 12, the US court ruled in favor of generic drug maker Sandoz in its dispute with Amgen over a near-copy of the blockbuster cancer drug Neupogen. Amgen filed a patent infringement lawsuit claiming that Sandoz violated the 2010 Biologics Price Competition and Innovation Act, which requires biosimilar makers to give a six-month notice of sales to rivals.
By Park Han-na (hnpark@heraldcorp.com)
The US Supreme Court has ruled that biosimilar developers can sell their drugs immediately after gaining approval from the Food and Drug Administration, instead of the current practice of giving a six-month notice to the original drug makers.
Sources say the ruling could be a boon for Reflexis, scheduled to make its crucial US debut later this year.
Samsung Bioepis had planned to launch the drug in October following FDA approval in April. But sources say Merck, the US marketing partner, could move up the schedule.
“The release date of Renflexis will be determined by Merck which holds the US marketing license, and there is a possibility that the release will be advanced following the court’s decision,” a source said on condition of anonymity.
“Samsung has also been paying keen attention to the ruling to catch up with Celltrion,” he added, citing Inflectra, another Remicade biosimilar that hit the US market in November last year through its retail partner Pfizer.
Renflexis’ early arrival could mean a loss of billions of dollars for the original Remicade amid the already heated competition with cheaper biosimilar rivals. Remicade earns US$4.45 billion in the US alone.
On June 12, the US court ruled in favor of generic drug maker Sandoz in its dispute with Amgen over a near-copy of the blockbuster cancer drug Neupogen. Amgen filed a patent infringement lawsuit claiming that Sandoz violated the 2010 Biologics Price Competition and Innovation Act, which requires biosimilar makers to give a six-month notice of sales to rivals.
By Park Han-na (hnpark@heraldcorp.com)
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