Neulasta Company Profile

09:56 EDT 21st September 2018 | BioPortfolio



One Amgen Center Dr
Thousand Oaks
United States of America


Phone: (866) 822-4832.

News Articles [70 Associated News Articles listed on BioPortfolio]

Amgen faces first Neulasta biosimilar rival as FDA approves Mylan drug

Amgen’s Neulasta is set to face its first competition in the US after the FDA approved Mylan’s biosimilar version of the blockbuster cancer infection biologic. Neulasta brought in $4.5 billion fo...

Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta

NewsAmgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta (peg...

Gedeon’s re-filed Neulasta biosimilar under EU review

European regulators have accepted a resubmission of Gedeon Richter’s biosimilar to Amgen’s Neulasta.

US OKs first biosimilar of Amgen's Neulasta

Mylan and Biocon's Fulphila has become the first biosimilar of Amgen's Neulasta to be approved by the US Food and Drug Administration.

Mylan and Biocon's Fulphila becomes first FDA-approved biosimilar of Amgen's Neulasta

The FDA has granted approval to Mylan and Biocon’s Fulphila, the first biosimilar version of Amgen’s Neulasta (pegfilgrastim) to be approved in the US. The pair’s second authorised biosimilar in...

FDA approves Mylan's biosimilar to Neulasta

(Reuters) - The U.S. Food And Drug Administration on Monday approved a drug from Mylan NV as the first biosimilar to Amgen's drug Neulasta to help reduce the risk of infection during cancer treatment....

Could Amgen Eye Alexion as a M&A Target to Offset Neulasta Decline?

With the June approval of Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim), the company is facing a potential revenue problem as the Mylan drug is expected t...

Pfenex hunting partners to advance Lucentis and Neulasta biosimilar candidates

Pfenex says it is actively looking for partners for its Lucentis and Neulasta biosimilar programmes, which are presently on hold.

Drugs and Medications [2 Associated Drugs and Medications listed on BioPortfolio]

Neulasta [Physicians Total Care, Inc.]

These highlights do not include all the information needed to use Neulasta safely and effectively. See full prescribing information for Neulasta.Neulasta (pegfilgrastim) injection, for subcutaneous us...

Neulasta [AMGEN INC]

These highlights do not include all the information needed to use Neulasta safely and effectively. See full prescribing information for Neulasta. Neulasta (pegfilgrastim) injection, for subcutaneous u...

PubMed Articles [0 Results]


Clinical Trials [39 Associated Clinical Trials listed on BioPortfolio]

A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-a...

Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta

This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.

Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy...

Neulasta in Type 1 Diabetes

This study seeks to determine if giving a a 12 week course of Neulasta to people with recent onset type 1 diabetes is (1) safe and (2) can preserve insulin production.

Efficacy and Safety Study With MYL-1401H and Neulasta

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvan...

Companies [3 Associated Companies listed on BioPortfolio]

Neulasta® (pegfilgrastim)

Neulasta® (pegfilgrastim) is approved for once-per-cycle dosing to decrease the incidence of infection (as manifested by febrile neutropenia)in certain cancer patients who are receiving chemotherapy.



TRACON Pharmaceuticals, Inc

Established in 2005 in New York as Lexington Pharmaceuticals, TRACON remains a privately held company. In April 2005, the company named Bert Liang as President and Chief Executive Officer and moved to...

More Information about "Neulasta" on BioPortfolio

We have published hundreds of Neulasta news stories on BioPortfolio along with dozens of Neulasta Clinical Trials and PubMed Articles about Neulasta for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Neulasta Companies in our database. You can also find out about relevant Neulasta Drugs and Medications on this site too.

Quick Search


Corporate Database Quicklinks

Searches Linking to this Company Record