BOW015 is the first infliximab biosimilar approved in India
BOSTON, MA, USA I September 15, 2014 I EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ:EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced today that it has received final marketing and manufacturing approvals for its Remicade® (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India.
“With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options,” said Amit Munshi, president and CEO of EPIRUS. “We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets.”
BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai which was inspected and approved in July of this year. The DCGI has issued the final clearances for BOW015, and EPIRUS and its commercialization partner Ranbaxy Laboratories Limited (Ranbaxy) expect to launch the drug, under the brand name Infimab®, by the first quarter of 2015.
“We believe that the data supporting BOW015’s clinical comparability to Remicade, presented earlier this year at the EULAR meeting in Paris, combined with EPIRUS’ focus on emerging markets, will help expand patient access to this important medicine,” added Jonathan Kay, M.D., 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. Dr. Kay serves as a clinical advisor to EPIRUS.
Ranbaxy and EPIRUS signed a licensing agreement for BOW015 in January of 2014. Under the terms of the agreement, EPIRUS will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets.
About BOW015
BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade®. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity.
More data on the Phase 3 study is available at www.abstracts2view.com/eular/.
EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted global markets. EPIRUS also plans to initiate an additional Phase 3 trial in Europe in early 2015.
About EPIRUS
EPIRUS is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS’ pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). The reference products for these product candidates – Remicade®, Humira®, and Avastin®, respectively – together generated $26.2 billion in global sales in 2013.
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 Biopharma
Post Views: 129
BOW015 is the first infliximab biosimilar approved in India
BOSTON, MA, USA I September 15, 2014 I EPIRUS Biopharmaceuticals, Inc. (EPIRUS, NASDAQ:EPRS), a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced today that it has received final marketing and manufacturing approvals for its Remicade® (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India.
“With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options,” said Amit Munshi, president and CEO of EPIRUS. “We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets.”
BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai which was inspected and approved in July of this year. The DCGI has issued the final clearances for BOW015, and EPIRUS and its commercialization partner Ranbaxy Laboratories Limited (Ranbaxy) expect to launch the drug, under the brand name Infimab®, by the first quarter of 2015.
“We believe that the data supporting BOW015’s clinical comparability to Remicade, presented earlier this year at the EULAR meeting in Paris, combined with EPIRUS’ focus on emerging markets, will help expand patient access to this important medicine,” added Jonathan Kay, M.D., 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. Dr. Kay serves as a clinical advisor to EPIRUS.
Ranbaxy and EPIRUS signed a licensing agreement for BOW015 in January of 2014. Under the terms of the agreement, EPIRUS will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets.
About BOW015
BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade®. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity.
More data on the Phase 3 study is available at www.abstracts2view.com/eular/.
EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted global markets. EPIRUS also plans to initiate an additional Phase 3 trial in Europe in early 2015.
About EPIRUS
EPIRUS is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS’ pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). The reference products for these product candidates – Remicade®, Humira®, and Avastin®, respectively – together generated $26.2 billion in global sales in 2013.
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 Biopharma
Post Views: 129
