Development, partnerships and launch of an adalimumab biosimilar
First written in FY2016. 3 of 9 entries say "Dropped", first in FY2019-Q2. Latest entry: FY2021-Q1.
No other company in this theme has enough history to compare yet.
- FY2021-Q1DroppedAnnual report
「Regarding development in China of the adalimumab biosimilar (development code: GBS-005) in the biosimilars business, Changchun Changsheng Bio-technology Co., Ltd., our partner for joint commercialization, was liquidated after being sanctioned in July 2018 over a scandal involving its rabies vaccine manufacturing business. Accordingly, we formally terminated the partnership with the company under the joint commercialization agreement.」
Following the liquidation of Changchun Changsheng Bio-technology Co., Ltd., the joint commercialization partnership for the adalimumab biosimilar in China was formally terminated. - FY2020DroppedAnnual report
「Our business platform consists of 3 businesses: biosimilars, innovative biologics and new biologics.」
The list of major marketed and development products and the description of the business for the fiscal year do not mention the continued development or licensing activities for the adalimumab biosimilar. - FY2019ReframedAnnual report
「We have already established the manufacturing process for the active pharmaceutical ingredient of the biosimilar to the reference product and obtained favorable data on its equivalence and comparability with the reference product. Going forward, we will promote licensing activities based on these results. In July 2018, Changchun Changsheng Bio-technology Co., Ltd. of China, the licensee for this development product, received a notice from China's National Medical Products Administration concerning violations of laws and regulations in its business. Accordingly, we decided to terminate joint commercialization of this development product with the company.」
While the policy is to terminate joint commercialization with the Chinese company, the initiative has been reorganized around pursuing new licensing activities based on the manufacturing process and comparative data. - FY2019-Q2DroppedAnnual report
「Regarding the partnership with Changchun Changsheng Bio-technology Co., Ltd. for the joint commercialization of the adalimumab biosimilar in China, we announced our policy of terminating the partnership after violations of laws and regulations were discovered in the company's core rabies vaccine manufacturing business.」
Regarding joint commercialization of the adalimumab biosimilar with Changchun Changsheng Bio-technology Co., Ltd., the policy shifted from continuing the partnership to terminating it. - FY2018RestatedAnnual report
「In September 2017, the transfer of technology for manufacturing the active pharmaceutical ingredient to Changchun Changsheng Bio-technology Co., Ltd. in China was completed, and full-scale joint commercialization in the country commenced.」
The completion of the technology transfer and the start of full-scale joint commercialization of the adalimumab biosimilar in China are being reiterated as ongoing initiatives. - FY2018-Q3RestatedAnnual report
「During the period, full-scale joint commercialization of the adalimumab biosimilar in China with Changchun Changsheng Bio-technology Co., Ltd. commenced in September.」
The full-scale launch of joint commercialization of the adalimumab biosimilar in China is being reiterated as an initiative already underway. - FY2018-Q2AdvancedAnnual report
「The transfer of manufacturing technology for the adalimumab biosimilar to Changchun Changsheng Bio-technology Co., Ltd. was completed in September 2017, and full-scale operations commenced toward joint commercialization in China.」
The adalimumab biosimilar progressed from partnership discussions and preparation to completion of the manufacturing technology transfer for China and the start of full-scale joint commercialization. - FY2017AdvancedAnnual report
「The company had already established the drug substance manufacturing process for the biosimilar of this product and obtained favorable data on its equivalence and comparability with the reference product. It had also been preparing for early entry into clinical trials while pursuing discussions on partnerships with pharmaceutical companies in Japan and overseas.」
For the adalimumab biosimilar, the company has progressed from establishing the manufacturing process and comparative data to preparing for early entry into clinical trials and conducting partnership discussions. - FY2016First statedAnnual report
「The company has already established the drug substance manufacturing process for the biosimilar of this product and obtained favorable data on its equivalence and comparability with the reference product. Based on these results, it will pursue early partnerships with pharmaceutical companies in Japan and overseas and steadily advance the launch of the biosimilar.」
GBS-005. The company describes the global sales of the reference product as approximately ¥1.5 trillion and plans to use the manufacturing process and comparative data in partnership negotiations.