미분류

Celltrion draws closer to debuting Remicade biosimilar in US by October

By KH디지털2
  • Published : Aug 17, 2016 - 17:25
  • Updated : Aug 18, 2016 - 10:19
[THE INVESTOR] South Korean biopharma developer Celltrion is drawing closer to its stated plans to debut its Remicade biosimilar in the US by October, as a major patent suit is showing signs of coming to an end.

The US District Court for the District of Massachusetts on Tuesday commenced its hearing over the validity of Janssen Biotech’s US-based formulation patent on Remicade, the firm’s top-selling rheumatoid arthritis treatment. The hearing is set to continue until Thursday.


The trial over Janssen's US-based 471 Patent came after the court accepted Celltrion’s request to speed up the legal process on the patent dispute it claims is being exploited by Janssen, a subsidiary of Johnson & Johnson, to delay the entry of biosimilar drugs to the US market.

Biosimilars refer to cheaper, near-replicas of biologic drugs that have lost patent protection. Celltrion’s Remsima, also known as Inflectra, is a biosimilar drug referencing Remicade, J&J’s blockbuster drug which racked up some $6.6 billion in worldwide sales last year.

Janssen’s patents on Remicade have expired in all countries except the US, where the company filed two new patents to extend its exclusive rights to the drug until September 2018 -- the 471 Patent and the 083 Patent involving its cell culture composition.

However, the US Patent & Trade Office ruled Janssen’s 471 Patent invalid in February 2015, a decision which Celltrion expects the Massachusetts District Court to repeat in the ongoing trial.

Celltrion also told The Korea Herald that it has provided sufficient evidence to prove that Remisima does not infringe upon Janssen’s 083 Patent as its source ingredients differ from that of Remicade.

Given the circumstances, Celltrion said it expects a “favorable outcome” from the US district court, though it is unable to confirm whether the patent dispute will come to a definite close with the current hearing.

Celltrion’s Remsima was approved by the US Food and Drug Administration in April under the name Inflectra. Celltrion’s US sales partner Pfizer has mentioned Oct. 3 as a possible release date for Inflectra, in accordance with the US regulation that states a biosimilar seller should notify the maker of the original drug of its sales agenda 180 days in advance.

The Korean drug maker has been selling Remsima in Europe since 2014. The cheaper drug has been prescribed to some 57,992 patients across Europe, as of 2015, taking away some 20 percent of Remicade’s net sales in the region, according to Celltrion.

By Sohn Ji-young/The Korea Herald (jys@heraldcorp.com)