Two biosimilar versions of infliximab have been recommended for approval in Europe, putting them on track to become the first monoclonal antibody biosimilars to be approved by the European Medicines Agency.*
On June 28, the agency's Committee for Medicinal Products for Human Use (CHMP) announced that it had recommended marketing authorizations for Remsima and Inflectra. Both contain the monoclonal antibody infliximab and were shown to be similar to Remicade, approved in the European Union since 1999. Authorization, or approval, of the two biosimilars is for the same indications as Remicade, which include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
This marks "the first time that the biosimilar concept has been successfully applied to such a complex molecule," an EMA statement said.
Infliximab, a tumor necrosis factor (TNF) blocker, was approved in 1998 in the United States and is also marketed as Remicade, for similar indications.
In Europe, the first biosimilar medication was approved in 2006, and a total of 12 biosimilar medications have been approved using a regulatory framework designed specifically for approval of biosimilars. A product-specific guideline for monoclonal antibodies has been established since December 2012. For approval, studies are required to show that the medication "does not have any meaningful differences from the reference medicine in terms of its quality, safety, and efficacy," according to the statement. The applicant must also establish a risk management plan that confirms the long-term safety and efficacy of the product, and monitors unexpected rare adverse events associated with the clinical use of the product.
The United States lags behind Europe with regard to the approval of biosimilars. A specific approval pathway for such products was created in the Affordable Care Act in March 2010. In 2012, the Food and Drug Administration issued draft guidance aimed at helping the developers of biosimilar products understand the expectations for such products and to provide a clear regulatory pathway for approval.
But to date, no biosimilar product has been approved in the United States.
emechcatie@frontlinemedcom.com
*CORRECTION, 7/9/2013: An earlier version of this story incorrectly described the marketing status of the two biosimilars.