Patients were randomly assigned one of three Plinabulin doses (5 mg/m2 [n=14], 10 mg/m2 [n=13] or 20 mg/m2 [n=14]) given by IV infusion 30 minutes after chemotherapy over four cycles, or the standard dose (6 mg) of Pegfilgrastim (Neulasta
) on Day 2.
Pegfilgrastim biosimilar named Fulphila (Pegfilgrastim-jmdb), produced by Biocon/Mylan, collaboration has recently been approved by the US FDA as the first Biosimilar to Neulasta
, which is an existing medical product used to treat low blood neutrophils levels.
, which helps to fight infection during chemotherapy, is nearly threeand-a-half times dearer in the US.
Asthma drug Spiriva costs nearly six times as much and Neulasta
, which fights infection during chemotherapy, is nearly three-and-a-half times dearer.
For the chemotherapy-induced neutropenia, we have shown last year that in combination with neulasta
or pegfilgrastim we could improve the care not only in bone pain but also reduce the chemotherapy induced severe neutropenia so that patients can stay on chemo and prolong their life.
sales were down 12% driven primarily by lower net selling price and, to a lesser extent, changes in inventory.
She led teams for the global submissions and approvals for the Repatha Pushtronex and managed the regulatory aspects of the Neulasta
OnPro; these are Amgen's first on-body injectors.
- The Mundipharma network of independent associated companies have launched Pelmeg (pegfilgrastim), a biosimilar of Neulasta
following European Commission approval in November 2018, the group said.
This donation will provide cancer patients in 18 developing countries with access to Neulasta
(pegfilgrastim), NEUPOGEN (filgrastim) and Vectibix (panitumumab).
To date, the FDA has approved 14 other biosimilars, including clones of blockbuster drugs like Humira and Neulasta
Pelmeg demonstrated comparable pharmacodynamics, pharmacokinetics and immunogenicity to its reference product Neulasta