A group of independent FDA advisers voted in favor of OK'ing Pfizer and Celltrion's take on the blockbuster inflammation treatment Remicade for all of the reference drug's approved indications, unswayed by protests from Johnson & Johnson.
FDA staff signaled support for Celltrion's biosimilar of Johnson & Johnson's Remicade in documents released ahead of a key panel vote, a positive development for the South Korean company as it works with Pfizer to tap the U.S. market.
Amgen's take on AbbVie's top-selling inflammation treatment is in line for FDA approval this year, but a patent fight between the two companies could keep it off the market into the next decade.
South Korea's Celltrion has recruited Medidata to provide eClinical technology as it works to develop copycat versions of the world's top-selling biological treatments.
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.
Oncobiologics CEO Pankaj Mohan is turning to a turbulent public market to provide the next big injection of cash that will be needed to keep his knockoffs of Humira and Avastin on their Phase III development schedules.
Amgen, at work on a biosimilar of AbbVie's best-selling treatment, got an unfavorable decision from U.S. regulators that could delay the launch of its take on Humira.
Partners Baxalta and Momenta Pharmaceuticals, among the many contenders looking to challenge the world's top-selling drug, posted positive data for their take on AbbVie's Humira with hopes of launching a competitor in 2018.
Partners Eli Lilly and Boehringer Ingelheim inched closer to challenging Sanofi's best-selling insulin, winning FDA approval for their take on the blockbuster Lantus as they wait for its U.S. patent protection to expire.
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.