RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > EMA Announces Approval of First Two Biosimilar Monoclonal Antibodies

EMA Announces Approval of First Two Biosimilar Monoclonal Antibodies

Posted 28 June 2013 | By Alexander Gaffney, RAC

In a major milestone, the European Medicines Agency (EMA) has announced the approval of the first two biosimilar monoclonal antibodies in the EU, Celltrion Healthcare's Remsima and Hospira's Inflectra.

Background and EMA Statement

Regulators explained that Remsima and Inflectra both contain the same active substance, infliximab, which was found to be similar enough to Remicade, an innovative biologic, to permit approval under the biosimilar pathway. Remicade has been legally marketed in the EU since 1999, and now Remsima and Inflectra will both be marketed for the same indications, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Because of the complexity of biological products relative to chemical drugs, companies are unable to make exact copies of a reference product without knowing the exact process used to manufacture it, a trade secret protected by EU law. Accordingly, EMA has demanded that biosimilar products show they are similar to an innovative reference product - not identical, as in the case of generic chemical drugs. Companies have been expected to conduct clinical testing to show that any differences between the products are not clinically significant.

While EMA has already approved several biosimilars, Remsima and Inflectra are the first of a complex class of biologics known as monoclonal antibodies.

"Monoclonal antibodies are structurally complex substances that can locate and bind to specific molecules, in the case of infliximab to tumour necrosis factor (TNF) alpha, a protein promoting inflammatory response, which causes many of the clinical problems associated with autoimmune disorders," EMA explained in a statement. "It is the first time that the biosimilar concept has been successfully applied to such a complex molecule," it added.

Industry Reaction

News of the approval won acclaim from the respective drugs' sponsors. In a statement, Hospira's Chief Medical Officer, Stan Bukofzer, said the approval represented "confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA."

"In a time when there is mounting pressure on healthcare budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining high quality standards," said Richard Davies, senior vice president and chief commercial officer at Hospira.

Celltrion issued a similar release, saying that "the European approval for Remsima is remarkably good news for patients who previously had limited access to advanced therapeutics, in particular, those hindered by the high cost of antibody biopharmaceuticals."

Celltrion's Remsima was approved based on clinical evidence generated in a trial of 874 patients, while Inflectra underwent similar trials with an unknown number of patients. In a statement, Hospira said the "Safety and tolerability of Inflectra was also demonstrated to be comparable to Remicade, supporting its approval."

"We believe that the first biosimilar mAb approval by the EMA will spearhead the start of a new era of biosimilar mAbs in the pharmaceutical industry," added Celltrion.

EMA Statement

Celltrion Statement

Hospira Statement

Tags: biosimilar, EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.