FDA says Sandoz's biosimilar is highly similar to Amgen's Enbrel after Sandoz answered question about data comparing it to US-approved product.
Sandoz Inc. avoided a potentially damaging equivalence problem in its biosimilar Enbrel filing by demonstrating its intricate understanding of the molecule.
The result seemed to ease FDA reviewers' concerns as they determined that Sandoz's GP2015 product is highly similar to its reference product, Amgen Inc.'s tumor necrosis factor blocker Enbrel...
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
