Module232025

12/05/2025

Drugs Approved for Inflammatory Bowel Disease – Adults and Paediatrics

Drug

Indication

Adult Approval

Paediatric Approval

Delay

CD

1998

2006

8 years

Infliximab

UC

2005

2011

6 years

CD

2008

2014

6 years

Adalimumab

UC

2012

2021

9 years

Certolizumab

CD

2008

Not yet

?

In Dec. 2024 J&J submitted for paediatric approval in UC to FDA

Golimumab

UC

2013

Not yet

CD

2014

Not yet

?

Vedolizumab

UC

2014

Not yet

?

Ustekinumab

CD

2016

Not yet

?

Tofacitinib

UC

2018

Not yet

?

7 drugs each approved for moderate to severe UC and/or CD, but only 2/7 approved for paediatric UC and for paediatric CD

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Drugs Approved in Oncology – Adults and Adolescents

2018

2019

2020

2021

2022

No. anticancer drug approvals

Overall

20

12

19

24

22

11 9

7 5

10 9

17 7

14 8

Innovator drug Generic/Biosimilar/Hybrid drug

No. Anticancer drug approvals with an indication relevant to adolescents

Overall

10 (50)

5 (42)

15 (79)

16 (67)

14 (64)

n (%) Innovator drug

7 (64)

2 (29)

7 (70)

10 (59)

8 (57)

n (%) Generic/Biosimilar/Hybrid drug

3 (33)

3 (60)

8 (89)

6 (86)

6 (75)

No. anticancer drug approvals whose indication statement was inclusive of adolescents

Overall

2 (20)

2 (40)

2 (13)

4 (25)

1 (7)

n (%) Innovator drug

2 (29)

1 (50)

1 (14)

2 (20)

1 (12)

n (%) Generic/Biosimilar/Hybrid drug

0 (0)

1 (33)

1 (12)

2 (33)

0 (0)

Source: Increasing the study of novel anticancer therapies in adolescents: Facilitating adolescent inclusion in adult research. Christina Bucci-Rechtweg et al. J ournal of Clinical Oncology Volume 41, Number 16_suppl https://doi.org/10.1200/JCO.2023.41.16_suppl.e13654

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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