The Drug Controller General of India (DCGI) has approved marketing and
manufacturing of Remicade (infliximab) biosimilar BOW015 of EPIRUS
Biopharmaceuticals, Inc., a Boston-based biopharmaceutical company
focused on the global development and commercialization of biosimilar
monoclonal antibodies. BOW015 is the first infliximab biosimilar
approved in India.
Ranbaxy Laboratories and EPIRUS Switzerland
GmbH, a subsidiary of Boston-based Epirus
Biopharmaceuticals, Inc., have signed a licensing agreement for BOWO15, a
biosimilar version of infliximab during January 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.
"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 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.
Central Drugs Standard Control Organization (CDSCO Approval) is such a body that regulates the checking. They do the verification of these medical products or cosmetics etc. before they are sold in the market. They will scrutinize your products and then only provide you with the certification of authenticity.
ReplyDeleteMedical Device Rules, 2017 came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO Approvals Services)
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