FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13, a Proposed Biosimilar Infliximab, for All Indications
Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade® (infliximab), by a vote of 21-3. CT-P13 is the first biosimilar monoclonal antibody (mAb) medication to be considered by the FDA. Celltrion is seeking approval of CT-P13 for the treatment of a variety of serious autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis, among others.
The Committee based its recommendation on the totality of evidence presented at the Arthritis Advisory Committee meeting, comparing CT-P13 to the U.S. reference product, Remicade®, in which the Committee concluded that the data submitted by Celltrion demonstrates CT-P13 is highly similar to U.S.-licensed Remicade®, notwithstanding minor differences in clinically inactive components. Further, the Committee noted that there were no clinically meaningful differences between CT-P13 and U.S.-licensed Remicade® in terms of the safety, purity, and potency of the product in the studied indications of rheumatoid arthritis and ankylosing spondylitis. The Committee acknowledged the extensive data provided by Celltrion to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use.
Remicade® has been licensed in the U.S. for 18 years and is indicated for the treatment of:
- Moderately to severely active Crohn's disease in adults and children;
- Moderately to severely active ulcerative colitis in adults and children;
- Moderately to severely active rheumatoid arthritis;
- Active ankylosing spondylitis;
- Active psoriatic arthritis; and
- Chronic severe plaque psoriasis.
"Given that this would be the first biosimilar monoclonal antibody to be approved in the U.S., this Advisory Committee meeting is an essential step in increasing acceptance of these critical medicines and increasing access for every patient who needs these treatments," said HyoungKi Kim, CEO of Celltrion. "We have experienced the benefits of biosimilars outside of the U.S., including Europe, and are looking forward to advancing our development program with the FDA.
"Our CT-P13 application in the U.S. is the first in an age where biosimilar mAbs are globally recognized as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable for patients," continued Kim.
If approved by FDA, Pfizer would assume commercialization rights for the medication in the United States under the proposed brand name, Inflectra™. The FDA’s decision is anticipated in April 2016.
Infliximab is a treatment for many autoimmune diseases, with more than 18 years of clinical data and experience since its FDA approval in U.S. in 1998. Celltrion’s CT-P13, a proposed biosimilar to Remicade®, is currently approved in 67 countries across the globe including Canada, Japan and throughout Europe. CT-P13 was licensed by the European Commission in September 2013 as Remsima®/InflectraTM for all indications of its reference product, Remicade®, including moderately to severely active adult and pediatric Crohn’s disease (CD), moderately to severely active adult and pediatric ulcerative colitis (UC), moderately to severely active rheumatoid arthritis (RA), severe active ankylosing spondylitis (AS), active psoriatic arthritis (PsA), and moderate to severe plaque psoriasis (PsO).
Based in Incheon, Republic of Korea, Celltrion, Inc. is a global biopharmaceutical leader with strong research and development capabilities in biosimilar monoclonal antibodies (mAbs) and novel drugs for various therapeutic areas, including oncology and autoimmune diseases. Founded in 2002, Celltrion focuses on promoting the health and welfare of patients in need of innovative biopharmaceutical products through world-class manufacturing and research facilities, developing state-of-the-art technologies, and establishing quality systems. Celltrion’s research and development expertise, coupled with a passion for patient well-being, is a unique set of capabilities that allowed the Company to enter into this highly challenging space.
Craig Heit, 347.451.4733
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
The 6th Annual World Patient Safety, Science & Technology Summit Kicked off with an Important Announcement about the Progress Being Made to Save Lives in Hospital Settings24.2.2018 10:00 | Pressemelding
The 6th Annual World Patient Safety, Science & Technology Summit kicked off with an important announcement about the progress being made to save lives in hospital settings. Nearly 4,600 hospitals in 44 countries have committed to adopting patient safety processes that are proven to eliminate preventable deaths in hospitals. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180224005027/en/ England’s Health and Social Care Secretary, Rt. Hon. Jeremy Hunt, launches groundbreaking new measures on Day One of the 6th Annual World Patient Safety, Science & Technology held in London (Photo: Business Wire) The Patient Safety Movement Foundation has taken on an inspiring and ambitious goal of reducing preventable patient deaths in hospitals to ZERO by 2020. The annual Summit in central London plays a major role in taking on that challenge with the participation of 300 global leaders, medical experts, medical technology CEOs, and patient
WuQi Technologies is Latest Licensee of CCww’s NB-IoT UE Protocol-Stack Software24.2.2018 09:06 | Pressemelding
Communications Consultants Worldwide Ltd. (CCww), global innovator of 3GPP® technologies, has licensed its NB-IoT protocol-stack software to WuQi Technologies Inc., a leading global developer of highly integrated mixed-signal SoC solutions, and the latest licensee of CCww’s NB-IoT Release 13 UE protocol-stack software. Communications Consultants Worldwide (CCww) is working with WuQi Technologies for the integration of its NB-IoT protocol-stack software onto WuQi Technologies’ highly innovative SoC. This relationship, catalyzed by T2M, is enabling the production of a highly integrated, very low power, NB-IoT SoC chipset targeting IoT Smart City, Smart Home, and wearable applications. CCww’s CEO, Richard Carter, said, “NB-IoT is CCww’s latest cellular Protocol-stack SW. We are excited to be working with WuQi to enable a sector-leading NB-IoT SoC, pushing back boundaries of performance and battery life for the next generation of IoT. See our demonstration at the Mobile World Congress (Hal
IDEMIA and Octo Telematics Reinvent Car Sharing Experience by Adding Facial Recognition to EasyOpen Solution23.2.2018 15:57 | Pressemelding
IDEMIA, the global leader in Augmented Identity for an increasingly digital world, announces today that it has implemented facial recognition technology on EasyOpen, a solution previously developed with its partner Omoove, a wholly-owned Octo Telematics company, Europe’s leading Shared Mobility technology provider. The digital enrolment process combined with facial recognition technology will securely enroll and authenticate the driver before EasyOpen automatically opens the car. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180223005506/en/ (Photo: Idemia) You will never rent a car the same way thanks to EasyOpen solution that combines IDEMIA’s expertise in secure service enablement and Omoove’s experience in Shared Mobility platforms and on-board technology. The first version of the solution was launched last year and allows drivers, who have already registered on the application, to use their smartphones as a key to open
SM-Optics Unveils First FLEXSET Chip, Paving the Way to Optical Micro Nodes23.2.2018 14:00 | Pressemelding
SM-Optics launches FLEXSET, a single chip embedding multiple processing functionalities raising the bar for performances, density and architectural flexibility. The FLEXSET is the heart of the Lightmode product family. FLEXSET OTN switching matrix scales from 300Gbps to 1Tbps and can be addressed by ports spanning from traditional low-speed services like 2Mbps over micro-OTN, to layer2 and layer3 over ODUFlex, 100G over ODU4 and 200G over FlexO. Thanks to its embedded capabilities including multi-technology OAM, packet processing, synchronization and fast protection functions, FLEXSET operates by design at the lowest latency performances and features an Intel Stratix 10 FPGA. Following the launch of micro-OTN, a revolutionary approach to efficiently extend OTN protocol to low speed services, the launch of FLEXSET advances the vision of a highly interconnected metro network and of micro nodes. Revolving around functional block elements, micro nodes collapse in few rack units OTN and pho
Bitcoin Miner HashGains’ Crowdsale to Build Green Cloud Mining Data Centers Receives Excellent Response23.2.2018 13:56 | Pressemelding
HashGains.com, a leading cryptocurrency mining platform, has launched its crowdsale program to build mega cryptocurrency cloud mining data centers in India and Canada which uses renewable energy like wind and solar as source of energy. “With the growing worries around bitcoin mining causing environmental damage, difficulty levels of mining increasing and returns heading southwards, there was no better opportunity but to build green energy data centers which run on free sources of energy like wind and solar, ensuring handsome mining rewards while taking care of environment,” said Mr Anuj Bairathi, CEO & Founder, HashGains, who is crypto enthusiast himself. HashGains is a growing cloud mining platform with more than 10,000 active customers enjoying mining returns and is expected to reach the mark of 1 million customers by 2020. To handle such a massive growth and ever growing demand of customers, it becomes even more important that mega mining centers are planned which can serve needs of
Stratecast Recognizes CARDINALITY as a “10 to Watch in 2018”23.2.2018 13:07 | Pressemelding
In their new report, “Digital Transformation Means New Tools for New Business” —part of the Global Operations, Orchestration, Data Analytics, and Monetisation (ODAM) stream—Stratecast recognises CARDINALITY for their new approach towards processing big data to deliver applications such as Customer Experience, Operational Intelligence, Network Analytics, Churn Management and Marketing Intelligence. Stratecast identified that the CARDINALITY Perception Platform brings large amounts of data from multiple CSP sources together in order to address a growing group of data analysis needs from different operational work teams and the wider business. It also does this at ingestion rates and storage levels previously thought not practical. "Using design principals tied to microservices and containerized solution components, the platform is a major advancement in meeting CSP data analysis needs at a price untouchable by previously-defined platforms," said Karl Whitelock, Stratecast director of glo