2014年1月6日讯/生物谷BIOON/--作为安进肿瘤生物药Neupogen的生物仿制药，诺华Zarzio近日获得了FDA官员的推荐，同时该药也有望成为美国第一个上市的生物仿制药。
根据2010年颁布的患者保护与平价医疗法案，只要具有足够的价格优势，研发的生物仿制药与原研药即使不百分百等同也可以获批。从2006年开始，欧洲的生物仿制药就逐渐获批，而美国由于缺乏相关的规章制度，生物仿制药市场发展仍相对滞后
生物药在癌症和其他免疫疾病的治疗方面具有更好的安全性和有效性，然而这也导致了价格过高，不是每个患者都可以消费得起。目前全球销量前十的药品当中，六种是生物技术药物。
由于生物技术药是从活细胞中研发获取，不能保证与原研药完全相同。价格低廉的仿制药是从不同细胞系中制取的，因此监管部门需要出台一系列制度保证仿制药的安全性和有效性在最大程度上接近原研药。
FDA报道，在审批的过程中，没有发现诺华的仿制药与原创药之间具有“有意义的临床差异”，简言之就是二者的安全性和疗效相同。2014年12月，诺华宣布在后期试验中，仿制药与原研药具有相似的安全性和疗效。
Neupogen是一种注射药物，用来预防化疗后患者的感染，该药物在2014年为安进贡献了12亿美元的销量，而诺华将会以Zarzio作为该仿制药的商品名，由诺华旗下仿制药单元Sandoz生产，销往全球40个国家。
FDA的评审认为，该仿制药应当与Neupogen保持一致，获批治疗所有5项适应症。该建议会在1月7号讨论，并得出最终决定。
根据Express Scripts 估计，生物仿制药降低20—30%的售价（相比于原研药），十年共能节约2500亿美元开支。(生物谷Bioon.com）
原文 Novartis’ Biosimilar Of Amgen’s Neupogen Gets FDA Staff Nod
Novartis AG (ADR) (NYSE：NVS) has received a recommendation by US Food and Drug Administration staff for the approval of its biosimilar drug， an imitation of Amgen， Inc.'s (NSADQ：AMGN) oncology biotech drug， Neupogen. The approval was based on the reviews from the staff that reported that the safety and efficacy profiles of the drug were similar to Neupogen.
Novartis’s imitation drug is the first biosimilar to be reviewed in the US. TheFDA can now approve imitation drugs under the Patient Protection and Affordable Care Act 2010， according to which， biosimilars can be developed which are not exactly identical and are cheaper. Biosimilars have been getting approved in Europe since 2006， but the lack of a regulatory framework in the US was the reason the country lagged in the biotech drug imitation market.
Biotechs have better safety profiles and are more effective in cancer treatment and other immunological diseases resulting in highly expensive price tags which are not affordable to everyone. Out of the world’s 10 best-selling drugs today， six are biotech drugs.
Biotech drugs are developed from living cells and thus cannot be copied exactly. Since the cheaper imitations are made from different cell-lines， regulatory authorities have to develop studies to be conducted to ensure the safety of the imitations and assess their safety and efficacy.
The FDA reported that the staff reviewing the biosimilar from Novartis did not find any "clinically meaningful differences" between the original and the copy. In December 2014， Novartis announced top-line results from a late-stage study showing that the imitation had similar safety and efficacy profiles as those of the original drug.
Neupogen is an injectable drug and has been developed to prevent infections in cancer patients who are already receiving chemotherapy. The drug generated $1.2 billion in revenue for Amgen in 2014. Novartis sells imitations for Neupogen in over 40 countries under the brand name Zarzio， manufactured by its generic drug unit， Sandoz.
The FDA reviewers recommended that the biosimilar should get approval for all five indications for which the original drug has been approved. The recommendation report will be reviewed by FDA experts on January 7 to make a final decision about the approval.
Biosimilars are expected to cost 20% to 30% less and are expected to save $250 billion in 10 years from their introduction， as estimated by Express Scripts Holding Company (NASDAQ：ESRX)
