Latest Headlines

Latest Headlines

Baxalta and Momenta target Humira with a Phase III biosimilar trial

Partners Baxalta and Momenta Pharmaceuticals are setting sights on the world's top-selling drug with a biosimilar of their own, moving into Phase III with a copy of AbbVie's cornerstone medicine.

Novartis comes for Enbrel in latest biosimilar shot at Amgen

A month removed from launching the U.S.'s first biosimilar, Novartis is again setting sights on an Amgen cash cow, lining up for FDA approval with a copy of the blockbuster Enbrel.

Amgen and Allergan clear Phase III with an Avastin biosimilar, looking to unseat a blockbuster

Partners Amgen and Allergan say their knockoff of Roche's blockbuster Avastin proved itself on par with its reference product, putting the pair a step closer to biting into the cancer drug's billions in annual revenue.

Merck and Samsung notch their first biosimilar victory with Enbrel knockoff

Partners Merck and Samsung Bioepis recorded their first approval in a sweeping biosimilars alliance, winning a South Korean OK for their copy of Amgen's blockbuster Enbrel.

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.