Trial Profile

A Randomized, Single-Dose, Double-Blind, Two-Sequence, Two-Period Crossover Study to compare Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of BP14 (Pegfilgrastim) with EU-approved Neulasta in Healthy Male Adult Subjects.

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 25 Mar 2025

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

31 Jan 2025 According to CuraTeQ Biologics media release, The company announced the CHMP within the European Medicines Agency (EMA) has adopted a positive opinion for drug (BP14, a pegylated filgrastim biosimilar) recommending the granting of a marketing authorization. And The CHMP positive opinion is expected to translate into a formal decision of approval by the European Commission in April 2025.
13 Aug 2021 Status changed from not yet recruiting to completed.
15 Jun 2020 New trial record

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com