A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have ...

Neulasta (pegfilgrastim) is a prescription drug used to prevent infection from certain cancer therapy and to treat radiation sickness. Neulasta’s cost may depend on factors such as your dosage and the ...

This is the company's third biosimilar Biologics License Application in the United States. After a lot of skirmish, Sandoz was finally able to launch the first-ever biosimilar product in the United ...

Neulasta (pegfilgrastim) is a brand-name drug that’s prescribed to treat radiation sickness and prevent certain complications of chemotherapy. Neulasta comes as an injectable solution. The dosage can ...

The FDA dealt Novartis’ Sandoz unit a blow last summer when it issued a complete response letter for the company’s biosimilar version of Amgen’s blockbuster drug Neulasta (pegfilgrastin). The Swiss ...

Mylan N.V.MYL and partner Biocon Ltd. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ...

Biotech giant Amgen announced in a press release Saturday that its PAVES phase 3 trial to evaluate colorectal cancer patients taking the white blood cell-boosting drug Neulasta met its primary ...

On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year. According to ...

Amgen will lose its patent for Neulasta in 2015, opening up the $4 billion in sales revenue to a rival generic. As the second-highest-earning drug for Amgen, will the company be able to make up the ...

Nearly two years after taking tremendous heat for the rising cost of EpiPens, pharmaceutical giant Mylan is making strides in the fast-growing market for biosimilars. Biosimilars are potentially ...

Amgen has received a letter from the FDA cautioning it against making misleading claims in advertising about its pegfilgrastim injector. The wording used in the advertisements claimed that the Onpro ...

Neulasta Delivery Kit Provides New Option for Patients Amgen announced the launch of Neulasta (pegfilgrastim) Delivery Kit that allows the healthcare provider to initiate Neulasta on the same day as ...