Merck's copies of the blockbuster anti-inflammatory treatments Enbrel and Remicade met their goals in Phase III, burnishing the pharma giant's plans to elbow its way into the long queue of companies readying cheaper versions of some of the world's best-selling medicines.
Biopharma production specialist Sartorius Stedim Biotech has acquired BioOutsource, a U.K. CRO focused on the growing demand for knockoffs of top-selling biologics.
Novartis made history this month with the first FDA approval of a biosimilar, and now a judge's ruling has cleared the way for its launch. The drug, Zarxio, is a copy of Amgen's blockbuster Neupogen, which is designed to boost white blood cell counts.
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.
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.
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.
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.
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 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.
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.