2014年1月6日訊/生物谷BIOON/--作為安進(jìn)腫瘤生物藥Neupogen的生物類似物，諾華Zarzio近日獲得了FDA官員的推薦，同時(shí)該藥也有望成為美國第一個(gè)上市的生物類似物。

根據(jù)2010年頒布的患者保護(hù)與平價(jià)醫(yī)療法案，只要具有足夠的價(jià)格優(yōu)勢，研發(fā)的生物類似物與原研藥即使不百分百等同也可以獲批。從2006年開始，歐洲的生物類似物就逐漸獲批，而美國由于缺乏相關(guān)的規(guī)章制度，生物類似物市場發(fā)展仍相對滯后。

生物藥在癌癥和其他免疫疾病的治療方面具有更好的安全性和有效性，然而這也導(dǎo)致了價(jià)格過高，不是每個(gè)患者都可以消費(fèi)得起。目前全球銷量前十的藥品當(dāng)中，六種是生物技術(shù)藥物。

由于生物技術(shù)藥是從活細(xì)胞中研發(fā)獲取，不能保證與原研藥完全相同。價(jià)格低廉的仿制藥是從不同細(xì)胞系中制取的，因此監(jiān)管部門需要出臺一系列制度保證仿制藥的安全性和有效性在最大程度上接近原研藥。

FDA報(bào)道，在審批的過程中，沒有發(fā)現(xiàn)諾華的生物類似物與原研藥之間具有“有意義的臨床差異”，簡言之就是二者的安全性和療效相同。2014年12月，諾華宣布在后期試驗(yàn)中，類似物與原研藥具有相似的安全性和療效。

Neupogen是一種注射藥物，用來預(yù)防化療后患者的感染，該藥物在2014年為安進(jìn)貢獻(xiàn)了12億美元的銷量，而諾華將會以Zarzio作為該仿制藥的商品名，由諾華旗下仿制藥單元Sandoz生產(chǎn)，銷往全球40個(gè)國家。

FDA的評審認(rèn)為，該類似物應(yīng)當(dāng)與Neupogen保持一致，獲批治療所有5項(xiàng)適應(yīng)癥。該建議會在1月7號討論，并得出最終決定。

根據(jù)Express Scripts 估計(jì)，生物類似物降低20—30%的售價(jià)（相比于原研藥），十年共能節(jié)約2500億美元開支。(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. The FDA 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