Latest Headlines

Latest Headlines

Samsung and Biogen verge on EU approval with an Enbrel biosimilar

Samsung Bioepis is months away from winning European clearance to market a copy of Amgen and Pfizer's blockbuster rheumatoid arthritis treatment Enbrel, securing a positive recommendation from EU regulators.

Novartis takes a third biosimilar shot at Amgen with a copy of the blockbuster Neulasta

Novartis is moving toward the U.S. market with a biosimilar of Amgen's Neulasta, awaiting FDA approval for a long-acting treatment designed to boost white blood cell count.

Amgen's Humira biosimilar clears Phase III and joins a crowd of contenders

Amgen's knockoff of AbbVie's top-selling Humira measured up to its reference product in a Phase III trial, clearing the way for the Big Biotech as it waits for the blockbuster injection to lose patent protection next year.

Pfizer cuts some biosimilar ties with Celltrion after its $17B Hospira deal

Pfizer, deepening its efforts in biosimilars after trading $17 billion for Hospira, is ditching a few redundant assets partnered with South Korean drugmaker Celltrion, paring down its pipeline as it eyes a growing global market.

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.