Celltrion announced on Oct. 4 that it had obtained additional approval from the U.S. Food and Drug Administration (FDA) for 80mg/0.8mL and 20mg/0.2mL (hereinafter referred to as 80mg and 20mg) dosages of its Humira (active ingredient: adalimumab) biosimilar, Yuflyma (development code: CT-P17), on Se
Samsung Biologics and Celltrion have made it to the top 10 of the World’s Most Trusted Healthcare Companies, a list jointly compiled by the American weekly magazine Newsweek and global market research firm Statista.According to Newsweek on Sept. 8, Samsung Biologics secured the second position in th
Celltrion announced on Sept. 4 that it recently obtained sales approval for its Avastin (bevacizumab) biosimilar Vegzelma from the Australian Therapeutic Goods Administration (TGA).Celltrion has been granted sales approval for Vegzelma in Australia for the entire range of indications approved for Av
On Aug. 31, Celltrion announced it has completed the product approval application for its autoimmune disease therapeutic “CT-P43,” a biosimilar of STELARA (ustekinumab), to Australia’s Therapeutic Goods Administration (TGA).Celltrion applied for CT-P43’s product approval in Australia for all indicat
On Aug. 17, Celltrion Inc. announced its decision to merge with Celltrion Healthcare Co. Through its disclosure, Celltrion explained that the decision to merge was made to integrate assets for large-scale investments, enhance cost competitiveness through the integration of development, production, a
Samsung Bioepis is said to be reviewing the acquisition of the biosimilar business unit of U.S. biotech firm Biogen.According to the biotech industry on Aug. 2, Samsung Bioepis is considering acquiring Biogen’s biosimilar business unit, which has recently been put up for sale.Biogen has been a colla
Companies investing in biopharmaceutical-related technologies and production facilities will now be eligible for a maximum tax deduction of 35 percent.On July 27, the Ministry of Economy and Finance held the 56th session of the Tax System Advancement Review Committee presided over by Deputy Prime Mi
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.Truxima’s US market share reached its highest level in 1Q23, but the drug’s quarterly price drop was also the largest in the past three years. We expect earnings growth to centere on Remsima SC in 2H
Samsung Bioepis' Humira biosimilar Hadlima (sold by Organon) has successfully been listed in the formulary recommendations list of U.S. Pharmacy Benefit Management (PBM) company Prime Therapeutics.On July 12 (local time), Prime Therapeutics announced its formulary recommendations list for Humira
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.Although SK Biopharm’s operating losses likely narrowed q-q in 2Q23, we believe that COGS-to-sales ratio returned to the previous high level, and SG&A expenses likely upped q-q on clinical costs. How
On July 1 (local time), the U.S. Humira biosimilar market, worth 24 trillion won a year, opened. In the first week alone, six Korean and foreign companies plan to launch their products.According to sources in the biotech industry on July 2, Samsung Bioepis launched Hadlima, a Humira biosimilar, in t
Samsung Biologics and Pfizer announced a strategic partnership on June 8 for the long-term contract manufacturing of multi-product drugs.Samsung Biologics and Pfizer first signed a contract manufacturing agreement for a single product last March, and Samsung Biologics is expected to manufacture Pfiz
Celltrion announced on June 5 that it had signed a contract with Rani Therapeutics, a biotech company based in San Jose, California, to develop an oral version of adalimumab (development name: RT-105).Earlier this year in January, Celltrion had signed a new drug development contract for the oral ver
The author is an analyst for Shinhan Securities. He can be reached at jaewonjeong@shinhan.com -- Ed.Pharmaceutical/bio sector to rebound in 2H23 on favorable macro conditions and progress in new drug pipelinesPharmaceutical/bio stocks have fallen out of investors’ favor with valuations declining on
Samsung Biologics has been embroiled in another patent infringement lawsuit. On Jan. 16, US pharmaceutical company Regeneron filed a patent infringement and prevention claim against Samsung Biologics and its subsidiary Samsung Bioepis in Seoul Central District Court in Korea.Regeneron claims that a
Samsung Electronics Chairman Lee Jae-yong met with global CEOs of big pharmaceutical companies and bio-venture startup incubation companies in the eastern United States, the world’s largest bio-cluster, to lay the groundwork for the success of Samsung’s biotech business.According to Samsung Electron
The author is an analysts of NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.At Celltrion Healthcare, 1Q23 OP should arrive in line with consensus at W63.6bn. Significant sales growth was confirmed for all major items in US prescription data for March. Although one-off cost i
Samsung Bioepis's biosimilar Renflexis, SK Biopharmaceuticals' epilepsy drug Xcopri, and Daewoong Pharmaceutical's botulinum toxin Nabota, are expected to exceed US$200 million in U.S. sales this year.The Renflexis sales added up to US$196 million last year. According to industry sources
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed.Top pick for Pharmaceuticals & Biotechnology We maintain BUY and TP of KRW1,200,000 on Samsung Biologics. Our TP remains unchanged despite revisions to 2023 ERP and RFR and slight downward adjustments to earnin
The author is an analyst of NH Investment & Securities. He can be reached at pk.park@nhqv.co. -- Ed.We expect Celltrion to post 4Q22 OP of W187.8bn, remaining roughly in line with our estimate, but missing consensus. The firm should report steady growth in 2023, backed by additional sales of Remsima