Latest Headlines

Latest Headlines

FDA panel backs Pfizer and Celltrion's Remicade biosimilar over J&J's objections

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.

Celltrion's take on J&J's Remicade is 'highly similar' to the original, FDA says

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 Humira biosimilar nears FDA nod, but legal hurdles remain

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.

Biosimilars developer Celltrion taps Medidata for trial tech

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.

Samsung and Biogen win first EU approval for an Enbrel copycat

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 looks to a $115M IPO to back its biosimilars business

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 hits a snag in its plot to challenge AbbVie's blockbuster Humira

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.

Baxalta and Momenta target AbbVie's blockbuster with positive biosim data

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.

FDA approves Lilly and Boehringer's take on Sanofi's top-selling insulin

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 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.