2014年12月4日讯 /生物谷BIOON/ --单抗生物制品堪称药品市场的一座金矿。近年来，随着大批单抗品牌药面临专利悬崖，生物仿制药正呈现井喷式增长，全球已掀起了生物药仿制热潮。
近日，总部位于美国波士顿的生物仿制药商Epirus联合印度合作伙伴兰伯西（Ranbaxy）在印度市场推出了首个类克（Remicade）生物仿制药——Infimab (BOWO15)，该药的上市比原计划提前了一个季度。凭借Infimab的上市，兰伯西也顺利进入单抗生物制剂领域。
类克（Remicade）是强生最畅销的单抗药物，该药成为全球生物仿制药商争相复制的产品，这一点毫不奇怪。根据FiercePharma公布的《2013年全球最畅销的10大药物》榜单，Remicade位列第三，销售额高达84亿美元，其中强生收入52亿美元，合作伙伴默沙东和日本田边三菱制药分享32亿美元。
在美国，Remicade专利将于2018年到期。除了Infimab，美国仿制药商Hospira与合作伙伴韩国Celltrion开发的类克（Remicade）生物仿制药Inflectra（Remsima)于2013年获欧盟批准，是欧盟首个单抗类生物仿制药，具有里程碑意义。
在印度市场，Infimab是上市的第2个生物仿制药。今年2月，迈兰（Mylan）及合作伙伴百康（Biocon）推出了罗氏抗癌药赫赛汀（Herceptin）的生物仿制药，该药也位列《2013年全球最畅销的10大药物》榜单。
未来5年，将有数个最畅销的重磅生物药失去专利保护，包括优泌乐（Humalog）、美罗华（MabThera）和Aranesp。由于生物仿制药工艺的复杂性，这类仿制药预计将以品牌药15%-30%的折扣销售，而非传统小分子仿制药高达90%的折扣。然而，由于生物制剂价格一贯昂贵，对于仿制药商和纳税人而言仍然是暴利药品。Epirus也有意成为仿制热潮中的一员。今年早些时候，Epirus就募集了3600万美元，用于Remicade及后续修美乐（Humira）、安维汀（Avastin）仿制项目。
英文原文：Epirus and Ranbaxy launch a Remicade biosimilar in India
This is the second knockoff of the global top seller to hit markets outside the U.S.
The biosimilar bonanza is underway, and Johnson & Johnson's ($JNJ) rheumatoid arthritis (RA) drug Remicade is at the center of the copycat action. Boston-based biosimilar maker Epirus Biopharmaceuticals is rolling out a knockoff of the monoclonal antibody (mAb) in India with partner Ranbaxy Laboratories, a year after Hospira got its Remicade version approved in Europe.
Epirus said today that the drug, its first, is coming to market in India a quarter ahead of schedule. It will be manufactured by Reliance Life Sciences at a facility in Mumbai and sold at a discount to the price of Remicade.
"It will be available in India at a very significant discount as compared to the innovator drug," Ranbaxy Vice President Rajeev Sibal, said when it was announced at the Indian Rheumatology Association Conference today, Pharmabiz.com reported. "More Indian patients will get the benefit of a world-class biologic treatment."
It is no surprise that Remicade is one of the drugs that biosimilar makers most want to copy. It ranks third on the FiercePharma list of top-selling drugs for 2013, with global sales of $8.4 billion. Johnson & Johnson's Janssen earns most of that, $5.2 billion, with partners Merck and Mitsubishi Tanabe Pharma sharing the rest of the spoils. The company did not respond to a request for a comment.
The popular treatment for the debilitating effects of rheumatoid arthritis doesn't go off patent in the U.S. until 2018 but IP protection has lapsed elsewhere. Hospira ($HSP) and its biosimilar partner South Korea-based Celltrion got their versions, Inflectra and Remsima, approved last year in Europe, a milestone since it was the first mAb biosimilar to be approved in the EU.
This is the second biosimilar to be launched in India. In February, Mylan ($MYL) and partner Biocon launched a copy of Roche's ($RHHBY) cancer drug Herceptin, also among the top 10 best-selling drugs of last year.
A number of other top-selling biologics come off patent in the next 5 years, including Humalog, MabThera and Aranesp. Many of these are blockbusters and have already been targeted by companies hoping to cash in on worldwide demand for life-extending biologics and the growing frustrations over the prices they command. Because of the complexities of creating biosimilars, they are expected to come at 15% to 30% discounts, rather than the 90% price cuts that often come with small molecule generics. But since so many of the priciest drugs are biologics, they still represent a potential windfall for biosimilar makers and payers.
Epirus intends to be among those. The company earlier this year raised $36 million for its work on its Remicade knockoff, as well as follow-up programs for Humira and Avastin.