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Samsung Bioepis, Merck & Co. launch Remicade biosimilar in US
기사입력 2017-07-25 16:38
Samsung Bioepis said Tuesday that it has begun selling a cheaper biosimilar drug referencing Johnson & Johnson’s Remicade in the US via its partner Merck & Co., marking the second Remicade copy to hit the US market.
The launch of Samsung’s Remicade biosimilar, named Renflexis, comes three months after its official approval by the US Food and Drug Administration in April.
Renflexis was developed by Songo-based Samsung Bioepis and is being commercialized in the US by its global sales marketing partner Merck & Co., known as MSD outside the US and Canada.
Samsung’s Remicade biosimilar will be introduced in the US at a wholesale acquisition price of $753.39, which is 35 percent cheaper than the current listing price of Remicade, according to the two drugmakers.
“Since we were established five years ago, we have striven to bring high-quality treatment options at a lower cost to US patients. Renflexis is our first step in meeting this important commitment,” Samsung Bioepis President and CEO Ko Han-sung said in a statement.
“We firmly believe biosimilars will play an instrumental role in making health care more accessible to patients across the US, and we will continue our relentless drive to advance one of the industry’s strongest pipelines.”
J&J-owned Janssen, the developer of Remicade, has filed a lawsuit against Samsung Bioepis in the US, claiming that its biosimilar copy Renflexis infringes three of its patents related to Remicade’s manufacturing process. A hearing has yet to be scheduled.
Samsung Bioepis has stated that Janssen’s moves were expected and that it did not infringe on Janssen’s patents.
Renflexis is the second biosimilar referencing Remicade to be commercialized in the US, following Celltrion’s Inflectra, which hit the US market via Pfizer from November 2016.
The introduction of Samsung’s Renflexis is slated to further eat into J&J’s Remicade sales as well as pose new competition to Celltrion’s Inflectra.
For now, Renflexis appears to have a price advantage over Inflectra, though the latter has got an early start on sales. While Renflexis is priced at 35 percent cheaper than J&J’s Remicade, Celltrion’s Inflectra is priced 15 percent cheaper than the original drug.
Samsung Bioepis already sells multiple biosimilars in global markets in addition to Renflexis, which has won approval in Europe, Australia and Korea. Its Enbrel biosimilar was the first of its kind to hit Australia, Canada, Korea and Europe.
Its biosimilar copy of Humira, Imraldi, was recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June. Its Herceptin biosimilar is currently under review by the EMA.
Founded in 2012, Samsung Bioepis is a joint venture between Samsung BioLogics and US-based Biogen with the former holding a 91.2 percent stake.
By Sohn Ji-young (jys@heraldcorp.com)
The launch of Samsung’s Remicade biosimilar, named Renflexis, comes three months after its official approval by the US Food and Drug Administration in April.
Renflexis was developed by Songo-based Samsung Bioepis and is being commercialized in the US by its global sales marketing partner Merck & Co., known as MSD outside the US and Canada.
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| (Samsung Bioepis) |
Samsung’s Remicade biosimilar will be introduced in the US at a wholesale acquisition price of $753.39, which is 35 percent cheaper than the current listing price of Remicade, according to the two drugmakers.
“Since we were established five years ago, we have striven to bring high-quality treatment options at a lower cost to US patients. Renflexis is our first step in meeting this important commitment,” Samsung Bioepis President and CEO Ko Han-sung said in a statement.
“We firmly believe biosimilars will play an instrumental role in making health care more accessible to patients across the US, and we will continue our relentless drive to advance one of the industry’s strongest pipelines.”
J&J-owned Janssen, the developer of Remicade, has filed a lawsuit against Samsung Bioepis in the US, claiming that its biosimilar copy Renflexis infringes three of its patents related to Remicade’s manufacturing process. A hearing has yet to be scheduled.
Samsung Bioepis has stated that Janssen’s moves were expected and that it did not infringe on Janssen’s patents.
Renflexis is the second biosimilar referencing Remicade to be commercialized in the US, following Celltrion’s Inflectra, which hit the US market via Pfizer from November 2016.
The introduction of Samsung’s Renflexis is slated to further eat into J&J’s Remicade sales as well as pose new competition to Celltrion’s Inflectra.
For now, Renflexis appears to have a price advantage over Inflectra, though the latter has got an early start on sales. While Renflexis is priced at 35 percent cheaper than J&J’s Remicade, Celltrion’s Inflectra is priced 15 percent cheaper than the original drug.
Samsung Bioepis already sells multiple biosimilars in global markets in addition to Renflexis, which has won approval in Europe, Australia and Korea. Its Enbrel biosimilar was the first of its kind to hit Australia, Canada, Korea and Europe.
Its biosimilar copy of Humira, Imraldi, was recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June. Its Herceptin biosimilar is currently under review by the EMA.
Founded in 2012, Samsung Bioepis is a joint venture between Samsung BioLogics and US-based Biogen with the former holding a 91.2 percent stake.
By Sohn Ji-young (jys@heraldcorp.com)