On 26 August 2026, Biocon announced that it received marketing authorisation from Japan’s Ministry of Health, Labour and Welfare for its pegfilgrastim biosimilar, referencing Amgen’s Neulasta® (known as G-Lasta® in Japan). The biosimilar will be exclusively marketed in Japan by Sandoz, with “Global Regulatory Partners Japan” serving as the marketing authorisation holder on Biocon’s behalf.
The Japanese approval comes over 8 years after Biocon’s biosimilar pegfilgrastim, Fulphila®, was approved in the US (approved June 2018, launched July 2018). Fulphila® has also been approved and launched in other regions, including Europe (approved November 2018), Canada (launched April 2020) and Australia (launched April 2020).
The only other reported pegfilgrastim biosimilar approved in Japan is Kidswell Bio Corporation/Mochida Pharmaceutical’s pegfilgrastim BS Subcutaneous Injection 3.6 mg, which was approved in September 2023.