Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.
FDA's review of Coherus BioSciences Inc.'s Neulasta (pegfilgrastim) biosimilar application could shed light on the data sponsors must submit to gain approval of their versions of the granulocyte-colony stimulating factor, particularly whether they must conduct studies in a patient population.
Apotex Inc. submitted a citizen petition to FDA in April asking the agency to require sponsors referencing Amgen Inc.'s Neulasta to withdraw their applications if they have not...
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
