Market Entry by Major Pharmaceutical Companies and Others into the Biosimilars Market
First written in FY2016. 9 of 19 entries say "Restated". Latest entry: 2026-08-13.
Kidswell Bio moved to the "Worse" side of this theme in 2017, 4 years before the typical company in this theme (2021).
The whole theme swung hardest in 2025: 4 of 8 companies on the "Worse" side.
4 other companies' latest entry also says "Worsened".
- FY2026MaterialisedAnnual report
「In the biosimilar business, entry by bio-AGs and competitors' biosimilars into the company's marketed products had previously been limited. However, since January 2026, bio-AGs and biosimilars of Eylea (aflibercept), a competing originator product, have been listed for reimbursement and launched in the anti-VEGF drug market in the ophthalmology field targeted by GBS-007 (ranibizumab). The company is currently examining the impact.」
The company states that market entry by competing bio-AGs and biosimilars has actually occurred in the area targeted by GBS-007. - FY2023-Q3RestatedAnnual report
「During the cumulative third-quarter period, there were no new business risks and no material changes in the business risks described in the annual securities report for the preceding fiscal year.」
The company disclosed that there had been no material changes regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2020RestatedAnnual report
「At present, the emergence of generics called biosimilars, which are the biosimilar equivalent of AGs, may expose the company to an impact similar to that seen with AGs in the generic drug market and may have a significant impact on its business plans and operating results.」
The company continues to disclose competitive risks, including entry by major companies and biosimilars. - FY2019RestatedAnnual report
「Major pharmaceutical companies and others in Japan and overseas may invest substantial R&D expenses and strengthen their entry into the market. In addition, activity surrounding authorized generics (AGs), which are generic drugs launched under license from the patent holder of the originator drug, has also intensified.」
The company continues to disclose competitive risks, including entry by major companies and AG trends. - FY2019-Q1RestatedAnnual report
「During the cumulative first-quarter period, there were no new business or other risks and no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2018WorsenedAnnual report
「Major pharmaceutical companies and others in Japan and overseas may invest substantial R&D expenses and strengthen their entry into the market. In addition, activity surrounding authorized generics (AGs), which are generic drugs launched under license from the patent holder of the originator drug, has also intensified.」
In addition to its previous explanation that entry by major pharmaceutical companies and others had become evident in some areas, the company has expanded the scope of competitive risk to include AG trends and the potential impact if biosimilar AGs enter the market. - FY2018-Q3RestatedAnnual report
「During the nine months ended September, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no new occurrence or material change regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2018-Q2RestatedAnnual report
「During the six months ended June, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no new occurrence or material change regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2018-Q1WorsenedAnnual report
「Companies operating in the biosimilar business have accelerated their respective development activities with the support of these policies, and competition in biosimilar development has consequently become gradually more active.」
In addition to its previous explanation that entry into the biosimilar market had become evident in some areas, the company describes the acceleration of development activities by each company and the intensification of development competition as current conditions. - FY2017MaterialisedAnnual report
「Accordingly, major pharmaceutical companies and others in Japan and overseas may actively enter not only Japan's generic drug market but also the biosimilar market, which is expected to be extremely large globally, and this has already become evident in some areas.」
The company itself states that entry into the biosimilar market by major pharmaceutical companies and others in Japan and overseas has already become evident in some areas. - FY2017-Q3RestatedAnnual report
「During the nine months ended September, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no material changes regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2017-Q2RestatedAnnual report
「During the six months ended June, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no new occurrence or material change regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2017-Q1RestatedAnnual report
「During the three months ended March, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no material changes regarding the risk of major pharmaceutical companies and others entering the biosimilar market. - FY2016First statedAnnual report
「Major pharmaceutical companies and others in Japan and overseas may invest substantial R&D expenses and strengthen their entry into the market. If major pharmaceutical companies and others in Japan and overseas gain a lead in biosimilar development, this may have a significant impact on the company's business plans and operating results.」
Although the company considers barriers to entry relatively high, it identifies competition in development with well-funded major companies as a risk.