The industry has been wrestling for years now over naming the first wave of biosimilars building on the coast of the American drug industry. The FDA's suggested solution: Take the generic name and add four random letters to make it a unique identifier.
Sorrento Therapeutics, among many companies in the orbit of billionaire entrepreneur Patrick Soon-Shiong, is looking to take a spot in the growing market for knockoffs of the world's top-selling biotech medicines.
Four years ago, Pankaj Mohan set out to build an independent biosimilars developer. Today, his company, Oncobiologics, is taking the next big step into late-stage work after raising $31 million from some prominent investors willing to back him at a critical point.
Partners Merck and Samsung Bioepis cleared late-stage trials with their knockoff of Humira, the world's top-selling medicine, setting the stage for global regulatory applications as the reference treatment comes off patent.
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.