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 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 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, 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.
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.
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.
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.
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 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.