Topic:

Biosimilars

Latest Headlines

Latest Headlines

The FDA offers a controversial solution to the biosimilars name game

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 buys into biosimilars with a Chinese antibody deal

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.

Oncobiologics raises $31M for a PhIII biosimilar play against Humira

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.

Merck and Samsung's Humira biosimilar comes through in Phase III

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 aces Phase III with knockoffs of Enbrel and Remicade

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.

Sartorius snags U.K. CRO BioOutsource with an eye on biosimilars

Biopharma production specialist Sartorius Stedim Biotech has acquired BioOutsource, a U.K. CRO focused on the growing demand for knockoffs of top-selling biologics.

Amgen fails to block Novartis' Neupogen biosimilar

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 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.