Development, Partnering and Launch of a Pegfilgrastim Biosimilar
First written in FY2016. 9 of 13 entries say "Restated". Latest entry: FY2024-Q3.
0 other companies' latest entry also says "Advanced".
- FY2024-Q3AdvancedAnnual report
「GBS-010, a pegfilgrastim biosimilar, obtained marketing approval in September 2023 and began being marketed in November of the same year.」
The pegfilgrastim biosimilar progressed from obtaining approval to beginning sales in November 2023. - FY2024-Q2AdvancedAnnual report
「GBS-010, a pegfilgrastim biosimilar, obtained marketing approval in September 2023. Sales were scheduled to begin by the end of 2023.」
The pegfilgrastim biosimilar progressed from establishing the manufacturing process, conducting partnership discussions and targeting launch to obtaining marketing approval in September 2023. - FY2020RestatedAnnual report
「The company has already established the drug substance manufacturing process for this biosimilar and obtained favorable data on its equivalence and comparability with the reference product. Using these as supporting data, it will continue to work diligently toward launch while pursuing early partnerships with pharmaceutical companies in Japan and overseas.」
Reaffirming the policy of pursuing partnerships in Japan and overseas and the launch of the pegfilgrastim biosimilar based on the manufacturing process and comparative data. - FY2019RestatedAnnual report
「The company is using the filgrastim biosimilar already launched in Japan as the raw material for this product, has established the drug substance manufacturing process, and has obtained favorable data on its equivalence and comparability with the reference product. In parallel with advancing manufacturing scale-up for commercialization, it is pursuing discussions on partnerships with pharmaceutical companies in Japan and overseas.」
For the pegfilgrastim biosimilar, the company continues to work on the manufacturing process, comparative data, scale-up and partnership discussions. - FY2019-Q1RestatedAnnual report
「① Development of the next-generation pegfilgrastim (PEG-G-CSF) biosimilar, a next-generation form of filgrastim (G-CSF)」
The company continues to list the pegfilgrastim biosimilar as an existing development program. - FY2018RestatedAnnual report
「The company has established the drug substance manufacturing process for this product and obtained favorable data on its equivalence and comparability with the reference product. In parallel with advancing manufacturing scale-up for commercialization, it is pursuing discussions on partnerships with pharmaceutical companies in Japan and overseas.」
For the pegfilgrastim biosimilar, the company continues to work on the manufacturing process, comparative data, manufacturing scale-up and partnership discussions. - FY2018-Q3RestatedAnnual report
「① Development of the next-generation pegfilgrastim (PEG-G-CSF) biosimilar, a next-generation form of filgrastim (G-CSF)」
The company continues to advance the pegfilgrastim biosimilar as an existing development program. - FY2018-Q2RestatedAnnual report
「① Development of the next-generation pegfilgrastim (PEG-G-CSF) biosimilar, a next-generation form of filgrastim (G-CSF)」
The company continues to list the pegfilgrastim biosimilar as an existing development program. - FY2017AdvancedAnnual report
「The company is using the filgrastim biosimilar already launched in Japan as the raw material for this product, has established the drug substance manufacturing process, and has obtained favorable data on its equivalence and comparability with the reference product. In parallel with advancing manufacturing scale-up for commercialization, it is pursuing discussions on partnerships with pharmaceutical companies in Japan and overseas.」
For the pegfilgrastim biosimilar, the company has progressed beyond establishing the drug substance manufacturing process and comparative data to manufacturing scale-up and partnership discussions in Japan and overseas. - FY2017-Q3RestatedAnnual report
「① Development of the next-generation pegfilgrastim (PEG-G-CSF) biosimilar, a next-generation form of filgrastim (G-CSF)」
The company continues to list the pegfilgrastim biosimilar as an existing development program. - FY2017-Q2RestatedAnnual report
「① Development of the next-generation pegfilgrastim (PEG-G-CSF) biosimilar, a next-generation form of filgrastim (G-CSF)」
The company continues to list the pegfilgrastim biosimilar as an existing development program. - FY2017-Q1RestatedAnnual report
「① Development of the next-generation pegfilgrastim (PEG-G-CSF) biosimilar, a next-generation form of filgrastim (G-CSF)」
The company continues to advance the pegfilgrastim biosimilar as an existing development program. - FY2016First statedAnnual report
「The company has already established the drug substance manufacturing process for this biosimilar and obtained favorable data on its equivalence and comparability with the reference product. Using these as supporting data, it will pursue early partnerships with pharmaceutical companies in Japan and overseas and steadily advance the launch of the biosimilar.」
GBS-010. The global market for the reference product is estimated at approximately ¥500 billion, with the established manufacturing process and equivalence and comparability data serving as the basis for partnerships and launch.