Samsung Bioepis Announces RENFLEXIS™ (infliximab-abda) Now Available in the United States
Samsung Bioepis Co., Ltd. today announced the launch of RENFLEXIS ™ (infliximab-abda), a biosimilar referencing Remicade® (infliximab), in the United States (US). RENFLEXIS ™ was developed by Samsung Bioepis, and is being commercialized in the US by Merck, which is known as MSD outside of the US and Canada. RENFLEXIS™ was approved by the US Food and Drug Administration (FDA) in April 2017.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170724005616/en/
Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)
“Since we were established five years ago, we have strived to bring high-quality treatment options at a lower cost to US patients. RENFLEXIS is our first step in meeting this important commitment,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We firmly believe biosimilars will play an instrumental role in making healthcare more accessible to patients across the US, and we will continue our relentless drive to advance one of the industry’s strongest pipelines.”
RENFLEXIS™ will be introduced in the US at a wholesale acquisition cost of USD 753.39, a 35 percent discount to the current wholesale acquisition cost of Remicade®. Wholesale acquisition costs do not include discounts that may be paid on the products.
About RENFLEXIS™ (infliximab-abda) for Injection, 100 mg
RENFLEXIS™ is a tumor necrosis factor (TNF) blocker approved in the U.S. for the following indications.
Crohn’s Disease – RENFLEXIS™ is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. RENFLEXIS™ is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.
Pediatric Crohn’s Disease – RENFLEXIS™ is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
Ulcerative Colitis – RENFLEXIS™ is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis – RENFLEXIS™, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
Ankylosing Spondylitis – RENFLEXIS™ is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Psoriatic Arthritis – RENFLEXIS™ (infliximab-abda) is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.
Plaque Psoriasis – RENFLEXIS™ is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. RENFLEXIS™ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Selected Safety Information about RENFLEXIS™ (infliximab-abda)
Patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue RENFLEXIS™ if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before RENFLEXIS™ use and during therapy. 1, 2 Treatment for latent infection should be initiated prior to RENFLEXIS™ use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with RENFLEXIS™ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RENFLEXIS™, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.
Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with RENFLEXIS™ (infliximab-abda), especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with infliximab products was similar to that expected in the general population, whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
RENFLEXIS™ (infliximab-abda) is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. RENFLEXIS™ should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue RENFLEXIS™ if new or worsening CHF symptoms appear. RENFLEXIS™ should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.
HEPATITIS B REACTIVATION
TNF inhibitors, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating RENFLEXIS™. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing RENFLEXIS™ for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with RENFLEXIS™. Discontinue RENFLEXIS™ in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of RENFLEXIS™ and monitor patients closely.
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (e.g., ≥5 times the upper limit of normal) develop, RENFLEXIS™ (infliximab-abda) should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported in patients using infliximab products. The causal relationship to infliximab therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of RENFLEXIS™ in patients who develop significant hematologic abnormalities.
Infliximab products have been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of infliximab products. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.
TNF inhibitors, including infliximab products, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering RENFLEXIS™ in patients with these disorders and consider discontinuation if these disorders develop.
Treatment with infliximab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
In clinical trials with infliximab products, the most common adverse reactions occurring in >10% of patients treated with infliximab products included, infections (e.g., upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
USE WITH OTHER DRUGS
Concomitant use of RENFLEXIS™ (infliximab-abda) with anakinra, abatacept, tocilizumab or other biologics used to treat the same conditions as RENFLEXIS™ is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
Live vaccines or therapeutic infectious agents should not be given with RENFLEXIS™ due to the possibility of clinical infections, including disseminated infections.
Bring pediatric patients up to date with all vaccinations prior to initiating RENFLEXIS™. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.
1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.
2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
Please see Prescribing Information for RENFLEXIS (infliximab-abda), including the Boxed Warning about serious infections and malignancies, at http://www.merck.com/product/usa/pi_circulars/r/renflexis/renflexis_pi.pdf and Medication Guide for RENFLEXIS at www.merck.com/product/usa/pi_circulars/r/renflexis/renflexis_mg.pdf .
i Remicade ® is a registered trademark of Janssen Biotech Inc.
Samsung Bioepis Co., Ltd.
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
Pandora to Acquire Leading Digital Audio Ad Tech Firm AdsWizz21.3.2018 13:00 | Pressemelding
Pandora (NYSE: P), the largest music streaming service in the U.S., today announced it will acquire AdsWizz, the global leader in digital audio ad technology. The addition of AdsWizz will upgrade Pandora’s ad tech capabilities, provide its advertisers with greater audience reach, and expand the company’s revenue opportunities. AdsWizz is one of the few ad tech firms that is completely dedicated to digital audio, serving some of the largest players in the industry. With digital audio advertising growing 42% year-over-year, according to the IAB, the combined offering of Pandora and AdsWizz will capitalize on this trend, while making it easier for publishers to monetize their inventory, and for advertisers to buy and measure their campaigns. “Since I joined Pandora six months ago, I have highlighted ad tech as a key area of investment for us. Today we took an important step to advance that priority and accelerate our product roadmap,” said Roger Lynch, CEO of Pandora. “With our scale in a
Fintech Entrepreneur and myPOS Founder Christo Georgiev Reveals Plans to Set Up a Chain of myPOS Stores across Europe21.3.2018 12:51 | Pressemelding
Founder of myPOS, Christo Georgiev announces plans to open myPOS flagship stores across Europe in an effort to bring the service closer to its customers. Designed for small and mid-sized businesses, myPOS offers affordable payment acceptance tools, winning the trust of over 40,000 enterprises across the EEA & Switzerland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180321005596/en/ An interior view of the myPOS London Store (Photo: Business Wire) Until now, the operational framework of myPOS included a network of promoters in almost every European country and an online store, owned and operated by myPOS. The next logical step was to sell through physical stores. On 8th February 2018, myPOS opened doors to its first flagship store, located on 36 Knightsbridge, London and marked the beginning of a new era for myPOS. Soon after, plans were revealed for other openings in Europe with another location coming up on 5th April 201
AI Expo Europe: The leading Artificial Intelligence Event to Arrive in the European Capital of Innovation, Amsterdam21.3.2018 12:47 | Pressemelding
The AI Expo Europe is set to arrive in the hub of AI innovation, Amsterdam, The Netherlands, this Summer (27-28th June) with an aim of ‘delivering AI for a smarter future.’ The well-connected Dutch capital is known for its unique, rich culture and canal-side views and was even awarded the European Capital of Innovation in 2016 by the European Commission. The city’s AI scene is thriving with the arrival of a world-class artificial intelligence hub by early 2021 and venture capitalist investment. The AI hub will be created in collaboration with the University of Amsterdam (UvA) and the City of Amsterdam at the Amsterdam Science Park, a place where education, research and entrepreneurship will come together as one. Geert ten Dam, president of the UvA’s Executive Board stated that: “Amsterdam is widely recognised both in the Netherlands and abroad for its leading scientific expertise in the area of AI…” This press release features multimedia. View the full release here: https://www.busines
Philip Morris International Shifts Entire Capacity of Its Cigarette Factory in Greece to Smoke-Free Products21.3.2018 12:31 | Pressemelding
Philip Morris International Inc. (PMI) (NYSE: PM) announced today that the factory of its Greek affiliate (Papastratos) in Aspropyrgos, has ceased cigarette production and is now exclusively producing HEETS, the tobacco units used with IQOS, the company’s most advanced smoke-free product. This first full conversion of a cigarette factory is a landmark step in our vision of a smoke-free future where people who smoke switch from the most harmful form of nicotine consumption – cigarettes – to scientifically substantiated smoke-free alternatives. The EUR 300 million investment included the construction of three new buildings and the replacement of cigarette production lines with high-tech facilities capable of producing 10,000 smoke-free tobacco units per minute. The conversion of the factory started in August 2017. The facility is expected to be fully operational by the end of 2018 and will create 400 new jobs. André Calantzopoulos, PMI’s Chief Executive Officer said: “This is a historic
GSMA Advances a Comprehensive Agenda on Digital Inclusion for Women Ahead of G20 Summit21.3.2018 12:00 | Pressemelding
The GSMA is supporting the sixty-second meeting of the Commission on the Status of Women (CSW62) taking place at the United Nations Headquarters in New York this month1 as part of its commitment to the Sustainable Developments Goals (SDGs), particularly SDG 5 (Gender Equality). The GSMA’s role at the event reflects its status as Topic Chair of the Digital Inclusion theme within the W20 (Women 20) group2, which will advise the G20 member states on issues around gender equality and the economic empowerment of women. At CSW62, the GSMA and its partners will be convening parallel events across a range of topics in this area, bringing together companies in the mobile ecosystem, governments, UN agencies and NGOs. “Developing forward-looking policies that promote digital inclusion for women is vital to achieving gender equality, serving to empower women in all corners of the world as well as providing an effective catalyst for economic growth,” said Mats Granryd, Director General of the GSMA.
fundinfo Launches New Fund News Service in Cooperation with UBS21.3.2018 08:00 | Pressemelding
To provide investors with up-to-date information and views from the fund managers with which they are invested fundinfo has launched a new service, in cooperation with UBS Global Wealth Management, that enables fund providers to publish fund-specific news in an automated and systematic way. The new service, known as News Dissemination, allows fund managers to provide their insights on the impact of recent market or political event – information not typically available in most fund documents. It is fully integrated into UBS's client-facing applications such as UBS eBanking, UBS Quotes, and Wealth Management Online (WMO). The service can also be integrated by other distributors. The easy-to-manage service, allows fund managers to create, edit and archive their news via a web-based fundinfo content management system, giving them complete control at all times. "This is a game changer. It's the first time fund providers have the opportunity to deliver ad-hoc and near real-time insights on t