Topic:

Biosimilars

Latest Headlines

Latest Headlines

Merck touts a bright future in biosimilars with a stable of would-be blockbusters

Merck may trail the first movers in the coming onslaught of blockbuster biosimilars, but the pharma giant is heralding a crop of late-stage copycat treatments it believes can snag a share of the soon-to-boom market.

Hospira and Celltrion hit a speed bump in their biosimilar dash

The FDA wants some more time to review Hospira and partner Celltrion's copy of Johnson & Johnson's blockbuster autoimmune drug Remicade, possibly delaying the drug's march onto the U.S. market.

Hospira and Celltrion storm the EU with biosimilars of J&J's Remicade

Partners Hospira and Celltrion are marching forward with copies of Johnson & Johnson's blockbuster autoimmune drug Remicade, bulldozing into Europe with products expected to disrupt a multibillion-dollar market.

Apotex targets Amgen's blockbuster with latest biosimilar app

The FDA accepted Apotex's application to copy an Amgen blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.

Competition to J&J's Remicade looms in U.S. as biosimilar conquers new markets

South Korea's Celltrion will start sales of Remsima, its biosimilar of Johnson & Johnson's Remicade (infliximab) in a dozen European countries in February, according to Joon Seok Kim of Celltrion Public Relations on Tuesday.

Amgen clears PhIII hurdle in crowded biosimilar race to topple Humira

Amgen wrapped up a second successful Phase III study of its Humira knockoff, ABP501, flagging its head-to-head success in a brief thumb's up announcing that the biosimilar hit its primary and key secondary endpoints. And barring any nasty surprises the positive readout on rheumatoid arthritis should give Amgen the ammunition needed to gun for an approval in a crowded field of late-stage contenders.

Samsung Bioepis advances its Enbrel biosimilar to an EMA review

The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been validated and accepted for review by the European Medicines Agency. It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.

India's Biocon keeps many irons in the fire, Malaysian plan on schedule

India's Biocon held a busy earnings call on Jan. 23 that highlighted extensive spending on research and keeping several deals rolling, though tight-lipped on a possible license to make Gilead's chronic hepatitis C products and said it will sell a 10% to 15% stake in its research services arm Syngene through an initial public offering.

Innovent's $100M deal signals how biotech is ready to explode in China

China biotech Innovent's recent success in raising $100 million in venture capital to help it build a pipeline of biosimilars could be a signal of how the industry may be set to explode in a country about to invest $6.45 billion in startups.

China's Innovent banks $100M to cash in on the biosimilar boom

Innovent Biologics has raised $100 million in venture cash in hopes of becoming the premier maker of biotech drugs in its native China, advancing a pipeline of biosimilars and proprietary treatments.