Pegfilgrastim
Approved as biosimilar to Neulasta®, Fulphila® received approval from the U.S. FDA in
June 2018, making it the first biosimilar Pegfilgrastim to be approved in the United
States, despite being the fourth to file. This underscores the robustness of Biocon’s
development and scientific expertise. Additionally, Fulphila® was the first biosimilar from
Biocon’s portfolio to be commercialized in the U.S, ahead of bTrastuzumab, Ogivri®.
2011
Early-stage CMC activities, encompassing cloning, upstream, downstream and formulation development followed by scale-up, are initiated to support the development of a biosimilar Pegfilgrastim, aiming to establish comparability with the reference product.
2014
A multi-center Phase III clinical trial is started across Europe for Biocon’s biosimilar Pegfilgrastim
2016
Biocon submits the Biologics License Application (BLA) for biosimilar Pegfilgrastim to the U.S. FDA and the Marketing Authorization Application (MAA) to the EMA. Regulatory submissions are also made to Health Canada and the Therapeutic Goods Administration (TGA), Australia
2018
Biosimilar Pegfilgrastim receives regulatory approvals from the U.S. FDA, EMA, Health Canada, and TGA, Australia. Biocon's product is the first biosimilar Pegfilgrastim to be approved in the U.S. and is launched under the brand name Fulphila®.
2023
Fulphila® (bPegfilgrastim) consolidates its position as a leading biosimilar in its
category in the U.S. market.
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