The U.K.'s cost effectiveness gatekeepers are giving their final blessing to a slew of rheumatoid arthritis biologics--but only for patients with advanced forms of the disease. And drugmakers aren't exactly happy about it.
Tokyo-based Daiichi Sankyo and U.S.-based Coherus Biosciences hit a successful Phase III mark in trials for a biosimilar of Amgen's rheumatoid arthritis therapy Enbrel.
Amgen and Pfizer's Enbrel officially has a biosimilar rival in Europe. And if the rollout goes anything like the recent EU launch of Remicade copy Remsima, the blockbuster brand will be in trouble.
A joint venture between Biogen and South Korean giant Samsung won Europe's first approval for a lower-cost version of Amgen and Pfizer's blockbuster Enbrel, planning to launch its injection in the coming weeks.
South Korea's Samsung Bioepis won European Commission approval for commercial sales of a biosimilar of Amgen's Enbrel, marking a first that will make its version of the rheumatoid arthritis treatment available across the European Union as well as Norway, Iceland and Liechtenstein.
The Canadian unit of U.S.-based Amgen has launched legal action against Samsung Bioepis, saying two of its patents for the autoimmune treatment Enbrel (entanercept) were violated by Samsung's biosimilar Brenzys.
Samsung Bioepis said South Korean regulators have approved the country's first "self-developed" biosimilar with sales approved of the company's Brenzys, a copy of Amgen and Pfizer's rheumatoid arthritis drug Enbrel and its Renflexis drug, a biosimilar of another arthritis treatment, Remicade.
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.
Right now, Novartis' Sandoz has the only biosimilar on the U.S. market. And it's looking to make it two.
Amgen is paying up to resolve claims that it broke the rules while marketing anemia drug Aranesp and anti-inflammatory blockbuster Enbrel. The company has settled with 48 states for $71 million, marking the latest state-level crackdown on alleged marketing violations in the pharma industry.