原标题：韩国Celltrion申请研发销售强生Remicade仿制药

随着生物医药领域专利悬崖的临近，世界各大生物医药公司都开始纷纷关注仿制药市场。最近韩国的生物技术公司Celltrion公司表示公司已经向FDA最新开辟的仿制药申请通道提交申请，希望获得授权在美国境内销售强生公司的畅销抗炎药物Remicade。这也是继诺华公司之后利用此通道的第二家公司。此前，今年七月诺华公司申请开发安进公司的Neupogen的仿制药版本。

强生公司的Remicade是一种治疗炎症的单克隆抗体药物，主要用于治疗类风湿性关节炎和克罗恩氏病，其2013年全球销售额达到了84亿美元。Remicade专利保护预计在2018年到期，Celltrion公司希望能够在今年获得这一药物的仿制药授权以便下一步布局，此前公司已经在去年获得了在欧盟境内销售Remicade仿制药的授权。公司除了Remicade，还正在进行罗氏公司畅销药Herceptin的仿制药研究和相关申请工作。

去年，由于Humira和Herceptin等畅销药专利保护相继到期，全球仿制药市场份额增至达到了13亿美元之多，而2018年将有一大批畅销药物失去专利保护，据此分析人士预测2020年这一市场将激增至350亿美元。

详细英文报道：

South Korea's Celltrion is aiming to be second line when biosimilars make their U.S. landfall, filing an FDA application to market a knockoff of Johnson & Johnson's ($JNJ) blockbuster Remicade.

The company is seeking approval for Remsima, a biosimilar of J&J's top-selling anti-inflammatory treatment, which pulled in about $8.4 billion in revenue last year. Celltrion is just the second company to file for approval under the FDA's newly created biosimilar pathway, following Novartis' ($NVS) July application to sell a copy of Amgen's ($AMGN) biological treatment Neupogen. Remsima is the first biosimilar monoclonal antibody submitted to the agency, the company said.

Celltrion expects to win agency approval within a year, giving it stateside clearance for a drug it already markets in more than 50 countries around the world. The company, along with partner Hospira ($HSP), made global headlines last year when the EU approved Remsima for use on the continent, clearing the way for a 2015 launch when the reference drug comes off patent.

J&J's treatment, widely used for rheumatoid arthritis and Crohn's disease, isn't slated to lose U.S. patent protection until 2018, but Celltrion has a plan to get Remsima on the U.S. market before that. The company has filed suit against Janssen, the J&J subsidiary that developed the drug, challenging the validity and enforceability of some remaining Remicade patents. J&J didn't respond to a request for comment on the pending litigation.

Meanwhile, thanks to changing regulations and a looming biotech patent cliff, the global market for biosimilars is poised to boom. According to a report from Allied Market Research, worldwide sales for copycat biologics will reach $35 billion by 2020 after scraping together just $1.3 billion last year, as blockbusters like Humiraand Herceptin lose exclusivity.

And Celltrion is positioning itself to cash in. Beyond Remsima, the company has a copy of Herceptin, which brought in $6.6 billion for Roche ($RHHBY) last year; and a take on the same company's Rituxan, which accounted for $7.8 billion in 2013 sales.

"Our U.S. biosimilar BLA application is garnering interest not only from other biosimilar developers, but from healthcare providers and the healthcare industry as a whole," Celltrion said in a statement. "This is because the medical community is aware that the eventual approval of sales of biosimilars in the U.S. market will signal an age wher biosimilar (monoclonal antibodies) are globally recognized as innovative, high-quality biologics, with equivalency in both efficacy and safety to their originator products, available to patients in need at a more affordable price."

<来源：新药汇>