FDA: Celltrion’s Remicade Biosimilar “Highly Similar” To Branded Drug

According to US Food and Drug Administration (FDA) documents, the agency is in favour of Celltrion’s biosimilar of Johnson & Johnson’s Remicade. The South Korean company is working with Pfizer to secure the FDA’s approval for the drug on the US market.

The FDA has called Remsima – Celltrion’s name for the biosimilar – “highly similar” to the original inflammation drug created by Johnson & Johnson. Across three clinical trials, the FDA found “no clinically meaningful differences” between the branded drug and the biosimilar.

Supporting data provided by Celltrion is considered to be sufficient by the FDA to support the drug’s use for treatment of ankylosing spondylitis and rheumatoid arthritis. Celltrion – in conjunction with Pfizer – is looking to gain regulatory approval for all of the drug’s proposed indications, which also include Crohn’s disease, psoriatic arthritis, ulcerative colitis and psoriasis.

An independent panel is expected to meet tomorrow to vote on whether Remsima should be approved for all of the same indications as Remicade. The meeting was originally set to take place in February of 2015, but the FDA delayed the vote citing “information requests pending with the sponsor of the application.”

Following last year’s $17 billion acquisition of Hospira, Pfizer gained marketing rights to Remsima. The biosimilar is already approved in Europe, prompting Pfizer to stop work on its own Remicade biosimilar.

“We look forward to Tuesday’s FDA Arthritis Advisory Committee meeting and a robust scientific discussion focused on patient well-being as an infliximab biosimilar candidate is discussed,” said a Johnson & Johnson spokesperson in a statement to FierceBiotech. “In testimony at the open hearing, Dr. Jay Siegel, chief biotechnology officer and head, scientific strategy and policy, Johnson & Johnson, will highlight some key facts and concerns for the advisory panel to consider, particularly with respect to extrapolation of indications.”

While the report is welcome news to Celltrion and Pfizer, Johnson & Johnson is already feeling the heat from Remsima in the European market where it is slowly gaining market share. As Remicade generates billions for Johnson & Johnson in the US, Celltrion’s Remsima could represent major competition for the drugmaker if it gains approval.

“Patient well-being is our first priority, and we fully support efforts to implement regulatory standards for the development and approval of biosimilars that ensure there are no clinically meaningful differences between the biosimilars and the reference products with respect to the high standards of safety and efficacy,” said the statement.