Among the new drugs to be launched is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim).

Napp’s Pelmeg, a biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), has been launched in the UK following approval late last year. This is Napp’s first launch of a product developed ...

The corps is a holistic structure. And let’s not even talk about the ‘attached’ units that break brigades into battalions and, let’s be honest, are not valued as much as the ‘main’ ones. It is time to ...

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference ...

With a robust product portfolio, including blockbusters like Enbrel, Prolia, Repatha, and Neulasta, and a strong pipeline of cancer drugs, Amgen continues to drive growth through cutting-edge ...

Purpose. The efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in critically ill patients with severe sepsis or septic shock were evaluated. Summary. The medical literature was ...

Among the upcoming products is NIOPEG®, a biosimilar of NEULASTA®, designed to reduce infection risks in patients undergoing anti-neoplastic therapy. The company maintains a strong financial ...

Invoking the recent Delaware Supreme Court decision Kellner v. AIM ImmunoTech Inc., 320 A.3d 239 (Del. 2024) (“Kellner”), which we discussed in previous client alerts (“Delaware Supreme ...

Last month, Sandoz revealed that the FDA had rejected its biosimilar of Amgen's Neulasta (pegfilgrastim), a longer lasting version of Neupogen. The FDA is set to make a decision over the coming ...