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First biosimilar infliximab to report American College of Rheumatology ACR20 response comparison at early time points
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No meaningful differences observed in safety or immunogenicity
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Data presented at EULAR Annual Conference 2014
PARIS, France I June 11, 2014 I Epirus Switzerland GmbH, a subsidiary of Boston-based Epirus Biopharmaceuticals focused on the global development and commercialization of biosimilar monoclonal antibodies, today announced clinical data from a Phase 3 study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis (RA). Jonathan Kay, MD and Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School, presented the results of this trial at the European League Against Rheumatism (EULAR) Annual Conference.
This study in severe RA patients was designed as an equivalence trial comparing BOW015 to Remicade. BOW015 achieved a week sixteen ACR20 response rate of 89.8%, compared to 86.4% for Remicade, an outcome which met its pre-specified statistical endpoint. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with RA, indicating a 20% improvement across a series of diagnostic parameters.
The study also included ACR20 comparisons at two, six, and fourteen weeks. No other clinical trial of a biosimilar infliximab has demonstrated and reported response to treatment at these earlier time points in advance of the sixteen week plateau phase.
Key secondary objectives of the study were to assess long-term efficacy, safety, tolerability, and immunogenicity. No meaningful differences were observed between BOW015 and Remicade. Results of the open label phase, including one year immunogenicity, one year safety, and long-term responder rates, are expected to be available in the third quarter of 2014.
“I am pleased to present data from the first study to compare early time points of the dose response curve of a biosimilar to its reference product,” said Jonathan Kay MD, “Data from early time points, prior to the plateau phase, allow for a more sensitive comparison of potency to demonstrate clinical equivalence.”
About EPIRUS
Epirus is building a global biosimilar enterprise to improve patient access to important medicines. The Company’s strategy for commercial success relies on targeted approaches for diverse global markets.
For emerging markets with accessible regulatory frameworks for biosimilars, Epirus develops partnerships with local companies to accelerate regulatory approval and commercialize its products.
For high-growth global markets where local manufacturing confers strategic and operational advantages, Epirus intends to use its SCALE™ platform to deliver an “In Market, For Market™” manufacturing solution with local partners.
For large markets with an established biosimilar regulatory framework, such as Europe, Epirus plans to commercialize its products using a combination of direct sales and local distributors.
More information about Epirus can be found at www.epirusbiopharma.com.
SOURCE: Epirus
Post Views: 143
-
First biosimilar infliximab to report American College of Rheumatology ACR20 response comparison at early time points
-
No meaningful differences observed in safety or immunogenicity
-
Data presented at EULAR Annual Conference 2014
PARIS, France I June 11, 2014 I Epirus Switzerland GmbH, a subsidiary of Boston-based Epirus Biopharmaceuticals focused on the global development and commercialization of biosimilar monoclonal antibodies, today announced clinical data from a Phase 3 study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis (RA). Jonathan Kay, MD and Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School, presented the results of this trial at the European League Against Rheumatism (EULAR) Annual Conference.
This study in severe RA patients was designed as an equivalence trial comparing BOW015 to Remicade. BOW015 achieved a week sixteen ACR20 response rate of 89.8%, compared to 86.4% for Remicade, an outcome which met its pre-specified statistical endpoint. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with RA, indicating a 20% improvement across a series of diagnostic parameters.
The study also included ACR20 comparisons at two, six, and fourteen weeks. No other clinical trial of a biosimilar infliximab has demonstrated and reported response to treatment at these earlier time points in advance of the sixteen week plateau phase.
Key secondary objectives of the study were to assess long-term efficacy, safety, tolerability, and immunogenicity. No meaningful differences were observed between BOW015 and Remicade. Results of the open label phase, including one year immunogenicity, one year safety, and long-term responder rates, are expected to be available in the third quarter of 2014.
“I am pleased to present data from the first study to compare early time points of the dose response curve of a biosimilar to its reference product,” said Jonathan Kay MD, “Data from early time points, prior to the plateau phase, allow for a more sensitive comparison of potency to demonstrate clinical equivalence.”
About EPIRUS
Epirus is building a global biosimilar enterprise to improve patient access to important medicines. The Company’s strategy for commercial success relies on targeted approaches for diverse global markets.
For emerging markets with accessible regulatory frameworks for biosimilars, Epirus develops partnerships with local companies to accelerate regulatory approval and commercialize its products.
For high-growth global markets where local manufacturing confers strategic and operational advantages, Epirus intends to use its SCALE™ platform to deliver an “In Market, For Market™” manufacturing solution with local partners.
For large markets with an established biosimilar regulatory framework, such as Europe, Epirus plans to commercialize its products using a combination of direct sales and local distributors.
More information about Epirus can be found at www.epirusbiopharma.com.
SOURCE: Epirus
Post Views: 143
