Celltrion Biopharma Ltd.

January 16, 2016 By Alex Keown , BioSpace.com Breaking News Staff THOUSAND OAKS, Calif. – Amgen stock is down this morning after U.S. patent officials denied company petitions to review patents on AbbVie ’s Humira , which will hinder Amgen’s development of a biosimilar to the blockbuster anti-inflammatory treatment, Reuters reported this morning. Amgen sought the review of the patent in June, arguing that the patents in question should not have been granted in the first place for Humira, Reuters said. In its denial the patent agency said “we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges,” Reuters reported. Despite the denial, Amgen told Reuters it expected to challenge to the legality of the patents in the courts. Amgen has nine biosimilar molecules in its pipeline, with the potential to launch five of its biosimilars between 2017 and 2019. The most advanced is ABP 501, a biosimilar for Humira. In Oct. 2015, Amgen announced positive Phase III results of ABP 501, a biosimilar to Humira (adalimumab) in patients with rheumatoid arthritis. Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010. Some see biosimilars as a threat to the profit margin of pharmaceutical companies. Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade, Reuters said . Express Scripts , a manager of drug benefit plans in the U.S., estimated the U.S. could save $250 billion over a 10 year span of 2014 and 2024 if 11 of the likeliest biosimilars reach the market. In October, Amgen and Dublin-based Allergan Inc. announced positive results in a Phase III trial for ABP 215, a biosimilar to Roche ’s cancer drug Avastin, used to treat advanced non-squamous non-small cell lung cancer (NSCLC). While Amgen is fighting AbbVie ’s patents, it lost its own fight with Novartis ’s subsidiary Sandoz over biosimilars. In September, Novartis and Sandoz launched the first approved biosimilar Zarxio in the United States after a U.S. court denied Amgen ’s appeals to block sales of the drug, which is a “copycat” version of that company’s blockbuster treatment Neupogen. Amgen sought to protect its revenue stream by blocking the sale of Zarxio in the United States. In July, a U.S. appeals court ruled that Novartis had to wait until Sept. 2 to launch its biosimilar of Amgen ’s. Also in September, the U.S. Food and Drug Administration accepted Sandoz ’ application for a biosimilar version to Amgen ’s Neulasta, called pegfilgrastim, which is used to fight infection in cancer patients. Neulasta earned $1.26 billion in the third quarter, according to Amgen ’s report. Over the summer the FDA accepted Sandoz ’ submission for approval of a biosimilar copy of Amgen ‘s blockbuster Enbrel drug. In August , Joe Jimenez , Novartis’s chief executive officer, predicted the biosimilar market will hit a stride in three to five years. Currently biosimilar drugs earn Novartis about $500 million annually and Jimenez told Reuters then that he expected that amount to increase by about 20 percent annually. Jimenez predicted the biosimilar role will take off by 2020 at the latest as popular prescription medications lose patent protection. Swiss-based Roche may soon see biosimilar competition in Europe for its blood cancer drug MabThera (Rituxan in the United States), which lost patent protection in Europe in 2014. Novartis isn’t the only company to focus on biosimilar development. Companies such as Israel’s Teva Pharmaceutical Industries Ltd. and South Korea’s Celltrion Biopharmaceuticals are developing biosimilars to treat cancer and other autoimmune diseases.

November 18, 2015 By Alex Keown , BioSpace.com Breaking News Staff ZURICH – Novartis ’ subsidiary Sandoz, Inc. continues to take aim at Amgen by filing with another biosimilar to an Amgen drug. This morning, Novartis ’s Sandoz announced the U.S. Food and Drug Administration (FDA) accepted its application for a biosimilar version to Neulasta, called pegfilgrastim, which is used to fight infection in cancer patients. This is the third biosimilar Sandoz has filed in the United States, which is part of plans to to 10 biosimilars over the next three years, the company said in a statement. Mark McCamish , head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said the ramping up of biosimilar filings is part of the company’s commitment “to expanding patient access to biologics in the U.S.” Sandoz said it has a pipeline of several biosimilars across various stages of development including five programs in Phase III clinical trials or registration preparation. The Neulasta biosimilar is supported by three clinical trials that indicates the therapy is “highly similar to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product`s indication,” the company said in a statement. Neulasta earned $1.26 billion in the third quarter, according to Amgen ’s report. That exceeded analysts’ expectations who pegged the drug to generate $1.17 billion, Reuters said . Last month the FDA accepted Sandoz ’s submission for approval of a biosimilar copy of Amgen ‘s blockbuster Enbrel drug, Reuters reported. In September, Novartis and Sandoz launched the first approved biosimilar Zarxio in the United States after a U.S. court denied Amgen ’s appeals to block sales of the drug, which is a “copycat” version of that company’s blockbuster treatment Neupogen. Amgen sought to protect its revenue stream by blocking the sale of Zarxio in the United States. In July, a U.S. appeals court ruled that Novartis had to wait until Sept. 2 to launch its biosimilar of Amgen ’s. By offering Zarxio at a price point 15 percent below Neupogen, Novartis and its biosimilar subsidiary Sandoz are looking to take a big chunk of the $1.2 billion the drug raked in last year. A 300 microgram syringe of Zarxio is expected to cost $275.66 and the 480 mcg version is expected to have a wholesale cost of $438.98, Reuters said. Wholesale price points for Neupogen are $324.30 and $516.45 for the same syringe formulations. Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010. Some see biosimilars as a threat to the profit margin of pharmaceutical companies. Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade, Reuters said. Express Scripts Inc. , a manager of drug benefit plans in the U.S., estimated the U.S. could save $250 billion over a 10 year span of 2014 and 2024 if 11 of the likeliest biosimilars reach the market, Reuters said. In August , Joe Jimenez , Novartis ’s chief executive officer, predicted the biosimilar market will hit a stride in three to five years. Currently biosimilar drugs earn Novartis about $500 million annually and Jimenez told Reuters then that he expected that amount to increase by about 20 percent annually. Jimenez predicted the biosimilar role will take off by 2020 at the latest as popular prescription medications lose patent protection. Swiss-based Roche may soon see biosimilar competition in Europe for its blood cancer drug MabThera (Rituxan in the United States), which lost patent protection in Europe in 2014. Novartis isn’t the only company to focus on biosimilar development. Companies such as Israel’s Teva Pharmaceutical Industries Ltd. and South Korea’s Celltrion Biopharmaceuticals are developing biosimilars to treat cancer and other autoimmune diseases.

October 27, 2015 By Alex Keown , BioSpace.com Breaking News Staff ZURICH – Following the approval of its landmark biosimilar drug in the United States, Novartis AG is looking for 10 more biosimilar filings within the next three years, Reuters reported in a brief this morning. In August Joe Jimenez , Novartis ’ chief executive officer, predicted the biosimilar market will hit a stride in three to five years. Currently biosimilar drugs earn Novartis about $500 million annually and Jimenez told Reuters then that he expected that amount to increase by about 20 percent annually. Jimenez predicted the biosimilar role will take off by 2020 at the latest as popular prescription medications lose patent protection. Swiss-based Roche may soon see biosimilar competition in Europe for its blood cancer drug MabThera (Rituxan in the United States), which lost patent protection in Europe in 2014. Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010. Citigroup analysts have predicted a transfer of at least $110 billion of value from innovator companies to copycat producers in the next decade, Reuters said. Express Scripts, a manager of drug benefit plans in the U.S., estimated the U.S. could save $250 billion over a 10 year span of 2014 and 2024 if 11 of the likeliest biosimilars reach the market, Reuters said. In September, Novartis launched the first approved biosimilar in the United States after a U.S. court denied Amgen ’s appeals to block sales of the drug, which is a “copycat” version of that company’s blockbuster treatment Neupogen. By offering Zarxio at a price point 15 percent below Neupogen, Novartis and its biosimilar subsidiary Sandoz are looking to take a big chunk of the $1.2 billion the drug raked in last year. A 300 microgram syringe of Zarxio is expected to cost $275.66 and the 480 mcg version is expected to have a wholesale cost of $438.98, Reuters said. Wholesale price points for Neupogen are $324.30 and $516.45 for the same syringe formulations. In addition to Novartis , companies such as Israel’s Teva Pharmaceutical Industries Ltd. and South Korea’s Celltrion Biopharmaceuticals are developing biosimilars to treat cancer and other autoimmune diseases, Reuters said. Novartis ’ Zarxio , which is manufactured by its subsidiary Sandoz, Inc. , was approved under the biosimilars pathway established by the Biologics Price Competition and Innovation Act. Data has shown Zarxio had “no clinically meaningful differences to the US-licensed reference product,” the company said. During the head-to-head PIONEER study between Zarxio and Neupogen, both products produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17 and 1.20 days for Zarxio and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle one was also similar (1.8 days ± 0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study. Neutropenia, the condition both drugs treat, happens when common white blood cells, neutrophils, dip below healthy levels, most commonly due to cancer treatment or advanced HIV/AIDS.