2015年2月27日訊/生物股BIOON/-Apotex公司，一家正在全球激烈的生物仿製藥市場中崛起的競爭者，2015年2月17日宣布， FDA受理公司產品Filgrastim非格司亭生物仿製藥Grastofil™的申請，這是Amgen公司優保津的生物仿製藥，由Apotex和Intas製藥公司共同開發。
這已經是Apotex公司在美國通過由生物仿製藥價格競爭和創新法案（BPCIA）創建的351(k)簡化審批途徑向FDA遞交的第二個生物仿製藥申請。Apotex公司之前通過351(k)簡化申請途徑提交的另一個產品是PEG化長效Filgrastim非格司亭製劑，目前也正處於FDA審評階段。 Apotex公司也是至今唯一一家有兩個FDA在審生物仿製藥（PEG-Filgrastim and Filgrastim)的幸運者。
Filgrastim非格司亭是Amgen公司應用重組DNA技術生產的甲硫氨酸人粒細胞集落刺激因子(Granulocyte colony-stimulating factor，G-CSF)，可促進造血輔助細胞增殖分化，明顯增加外周血中性粒細胞數，並有增強粒細胞的功能，如對成熟的中性粒細胞可增強其吞噬活性和抗體依賴性細胞介導的細胞毒作用。根據Symphony Health Solutions公司的數據， Neupogen？( Filgrastim非格司亭) 2014年大約有10億美金的銷售額。
「我們非常高興能夠成為全球首先將高質量生物仿製藥引入美國市場的公司之一」，Apotex 公司董事長和CEO Jeremy B. Desai 博士說，「對於40年來一直在全球範圍內提供高質量、可負擔性治療藥物的Apotex來說，進入美國醫藥的前沿領域是我們發展歷史的分水嶺事件」，他補充到，「對於患者，支付方和藥物提供者來說，生物仿製藥必將帶來很明顯的好處。我們致力於在促進美國公眾獲得可負擔的救命藥物以及大幅度降低美國醫療保障體系成本方面發揮關鍵的作用」。
該產品在美國將由Apotex的子公司ApoBiologix™全權進行銷售。
今年年初，美國FDA藥物評審中心（CDER）舉行的腫瘤藥物專家顧問委員會（ODAC）會議上，評議樂諾華旗下山多士（Sandoz）公司申報的安進公司Neupogen的生物仿製藥EP2006（歐洲商品名：Zarzio）的生物製劑許可申請（BLA）。經過聽取山多士公司的申報報告、FDA評審員的評議報告和公眾聽證，FDA專家小組以14：0的不記名投票結果一致推薦批准山多士的EP2006上市（美國商品名：Zarxio）。 可以預見，在不久的將來，美國市場上的Neupogen生物仿製藥將有一番激烈的「搏鬥「。
關於Apotex公司
Apotex Inc.成立於1974年，是加拿大最大的現代化製藥企業，在全球擁有6000多名員工，從事藥品的研製開發，生產製造與上市銷售。APOTEX生產的奧貝品牌藥品行銷全球115個國家，享有國際聲譽。
APOTEX擁有先進的生產設備，其生產能力已超過加拿大所有其它製藥企業生產能力的總和。APOTEX生產200多個品種、2000多個規格和劑型，其中包括固體製劑、液體製劑、注射劑、搽劑及噴霧劑等，僅固體製劑的年生產能力即達180億片/膠囊。
APOTEX每年投入年銷售額的20%用於新藥的研製和開發，其研發費用的投入列加拿大所有企業的前列，位居加拿大製藥行業前列。新產品的研製和開發是APOTEX重要的發展方向，涉及血液科藥物、心血管藥物、抗生素、精神科藥物和抗腫瘤藥物等多個領域。（生物谷Bioon.com）
Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Grastofil™)
Company currently has two biosimilar applications (filgrastim [Neupogen™]) and pegfilgrastim [Neulasta™]) under active review by FDA.
Apotex Inc.， a rising competitor in the global biosimilars market， announced today that， as of February 13th， 2015， the US Food and Drug Administration has accepted for filing the company's application for Filgrastim [Grastofil™]， a biosimilar version of Amgen's Neupogen™. This product has been jointly developed with Intas Pharmaceuticals Ltd.
This is the second follow-on biologic FDA submission for Apotex via the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA). Apotex also has a 351k biosimilar application for the long acting pegylated formulation of filgrastim currently under FDA review. Apotex is the only company to date to have two biosimilar filgrastim applications (pegfilgrastim and filgrastim) currently under active review by FDA. Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. According to Symphony Health Solutions， Neupogen™ had approximately $1-billion in sales in calendar year 2014.
"We are very pleased to be at the forefront of companies who will introduce high quality biosimilar products into the US marketplace，" said Apotex President and Chief Executive Officer， Dr. Jeremy B. Desai. "Our entry into this new frontier of medicine in the United States is a watershed event in Apotex's 40 year history of providing quality， affordable medicines to patients in need around the globe，" Desai added. "The benefits for patients， payers and providers from biosimilars will be significant. We are dedicated to playing a leading role in the effort to increase the American public's access to more affordable versions of these life-saving therapies and generate substantial savings for the US health care system，" Desai added.
The product will be marketed in the United States by ApoBiologix™， a division of Apotex Corp.
About Apotex
Apotex is the largest Canadian owned pharmaceutical company with over 10，000 employees globally and with estimated sales of approximately $2 billion. The company's US headquarters is based in Weston， Florida. With its worldwide manufacturing sites， Apotex can produce up to 24 billion dosages per year. It produces 300 medicines in 4，000 dosages and formats that are exported to 115 countries. It has 500 products under development and will spend $2 billion over the next 10 years on research and development.