Business Wire

Samsung Bioepis Continues Global Expansion, Enters Brazilian Biopharmaceutical Market with BRENZYS™ (etanercept)

Share

Samsung Bioepis Co., Ltd. today announced its expansion into the Brazilian biopharmaceutical market. The first product available in the country is BRENZYS™ (etanercept), a biosimilar referencing ENBREL®.i BRENZYS™ was approved by Agência Nacional de Vigilância Sanitária (ANVISA), the country’s health regulatory agency, in December 2017 for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

Samsung Bioepis is continuing its business expansion in multiple markets across the world, including mainland China, where the company entered into partnerships with 3SBio and C-Bridge Capital to develop and commercialize multiple biosimilar candidates from Samsung Bioepis.

BRENZYS™ is being supplied to Sistema Único de Saúde (SUS), the country’s public health system, through a Productive Development Partnership (PDP) between Samsung Bioepis and local partners, Bionovis and Bio-Manguinhos/Fiocruz.

Under the PDP, Samsung Bioepis will supply biosimilar products or product intermediaries to the local partners for sale to SUS for a period of 10 years. During this period, Samsung Bioepis will provide technology transfer to the local partners, so that manufacturing responsibilities can be gradually transferred to enable local manufacturing in Brazil. The PDP scheme was introduced by the Brazilian government in 2008, in order to expand access to medicines and support the country’s pharmaceutical industry through technology transfer from established companies in return for guaranteed purchases from SUS.

In Brazil, over 75% of patients nationwide rely on SUS for health care coverage.ii While biologics represent approximately 4% of all medicinal products acquired by SUS, they account for approximately 51% of government spending on medicinal products.iii

“We are excited to provide our high-quality biosimilars to patients across Brazil, and look forward to working with our local partners to enhance patient access to high-quality healthcare. Equally important, by sharing our scientific knowledge with our local partners, we hope to do our part in contributing to the long-term development of the Brazilian biopharmaceutical industry,” said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and health care systems across the world.”

Samsung Bioepis’ products are now available across five continents: North America, Europe, Asia, Oceania, and Latin America. The company currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT® (trastuzumab). Over 170,000 patients are currently under treatment with Samsung Bioepis’ biosimilars in Europe. In the United States, the company has one biosimilar – RENFLEXIS® (infliximab-abda) – approved and marketed. ONTRUZANT® (trastuzumab-dttb) received approval from the U.S. Food and Drug Administration (FDA) in January 2019, while ETICOVO™ (etanercept-ykro) and HADLIMA™ (adalimumab-bwwd) received FDA approval in April and July 2019, respectively.

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 cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

_____________________________
i ENBREL is a registered trademark of Pfizer
ii Jurberg C, Humphreys G. Brazil's march towards universal coverage. Bull World Health Organ. 2010;88(9):646-7.
iii Debiasi M, et al. Biosimilars in Brazil: The Beginning of an Era of Broader Access. Journal of Cancer Therapy. 2017; 8:814-826.

Contact information

Na Yun Kim
+82-31-8061-1604
nayun86.kim@samsung.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Leading Consumer Brands Ariel, Pantene and Fairy Accelerate Journey to Deliver P&G’s Ambition 203017.2.2020 07:00:00 EETPress release

Today the Procter & Gamble Company (NYSE:PG) announced significant advances across European sustainability projects in pursuit of its “Ambition 2030” goals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200216005020/en/ Ariel (Photo: Business Wire) P&G is driving the circular economy for recycled plastic in Europe through the use of circular resin in its hair care packaging (polyethylene terephthalate - PET) and its Ariel Liquid detergents bottles (partnership for the supply of recycled high-density polyethylene - HDPE). Furthermore, the company is celebrating notable distinctions in its effort to lead the industry in packaging, sorting, and post-consumer recycled resin supply with the HolyGrail intelligent packaging project, winner of both the Circular Economy innovation of the year category in the Edie Sustainability Awards in the UK, and the 1000 Efficient Solutions Label by the Solar Impulse Foundation. Lenor, Unstoppab

Shekel Brings World’s First Micro-Market to EuroShop 202016.2.2020 11:15:00 EETPress release

Shekel Brainweigh Ltd. (ASX: SBW) and Hitachi today unveiled Capsule, the world’s first framework for a cost-effective autonomous micro-market solution based on Hitachi’s LiDAR sensors and Shekel’s Product Aware Shelves at EuroShop 2020. The first Capsule store is expected to launch in Europe in Q2 2020 and is on display at Shekel’s booth #D86 at Hall 3. “Micro-markets are the fastest growing segment of convenience shopping. We see them exploding in high traffic areas, such as workplaces, campuses, train stations and airports,” said Hideki Hayashi, Sales and Marketing Manager, Hitachi EU Ltd. “Deploying the joint Shekel-Hitachi solution enables retailers and micro-market operators to provide the 24/7 frictionless shopping experience consumers demand without sacrificing accuracy, performance or profitability.” In a recent consumer survey commissioned by Shekel, 41 percent of respondents specified that if they could return items and purchase more than one item at a time, they would be mo

Designer Outlet Croatia Builds Footfall With a New Hybrid Retail Destination and Shopper Traffic Counting Solution16.2.2020 10:00:00 EETPress release

Johnson Controls announced that Sensormatic Solutions, its leading global retail solutions portfolio, will feature its ShopperTrak visitor analytics and shopper insights in Designer Outlet Croatia. Majority-owned by Ingka Centres, the retailer has enhanced shopper traffic performance by adding an aspirational, ‘hybrid’ retail destination to the existing IKEA Store in Zagreb. The IKEA store in Zagreb opened in August 2014 and attracts 1.5m visitors annually. Boasting 38,000 sqm of retail space, it is one of the biggest IKEA-owned sites in Europe. To drive ambient footfall and encourage more store visits to the IKEA Zagreb store, Ingka Centres group (previously known as IKEA Centres) and ROS Retail Outlet Shopping, strategically opened an adjoining designer outlet centre, Designer Outlet Croatia, in June 2018. Covering 15.000 sqm of retail space, the outlet centre contains 74 stores of discounted luxury clothing brands, including Tommy Hilfiger, Calvin Klein, Guess, and adidas. It also o

Celltrion Healthcare showcases positive 1-year results for novel subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis presented at The European Crohn's and Colitis Organisation (ECCO) annual congress14.2.2020 18:04:00 EETPress release

Celltrion Healthcare today announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC). Results presented at The European Crohn's and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV formulation of CT-P13 in terms of efficacy and safety throughout the 1-year treatment period.1 In the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of whom 105 (80.2%) patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (<80kg) or 240 mg (≥80 kg) every 2 weeks in the SC arm, or continued on IV 5 mg/kg ev

Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn’s Disease14.2.2020 17:37:00 EETPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD). The study evaluated patients who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy at weeks 0 and 2.1 The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008]),** meeting the study’s primary endpoint.1 These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria. “The VISIBLE 2 study showed that the investigational subcut

Mary Kay Participates in 2020 Generational Dermatology Palm Springs Symposium14.2.2020 16:50:00 EETPress release

Mary Kay Inc., a global beauty company and leader in skin care innovation, continued its decades-long support of the beauty and scientific communities by recently supporting the 2020 Generational Dermatology Palm Springs Symposium from Feb. 14 – 16. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200214005108/en/ Dr. Lucy Gildea, Chief Scientific Officer of Mary Kay Inc. (Photo: Mary Kay Inc.) Generational Dermatology, founded by Dr. Wendy E. Roberts, takes a multi-decade approach to the evolving aging patient, including medical, surgical and aesthetic dermatology. This symposium is targeted toward dermatologists and other core specialists at all stages of their careers. Participants join extraordinary faculty and key opinion leaders at the Omni Rancho Las Palmas, Rancho Mirage. “Our commitment to skin care science isn’t just about making new Mary Kay products,” said Dr. Lucy Gildea, Chief Scientific Officer at Mary Kay. ”Our

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom