ADALIMUMAB

Brand name:

• Hyrimoz®

Form and strength:

Please search for and view the medicine's Public Summary Document (PSD) for more information

Submission sponsor:

Sandoz Pty Ltd

Condition/indication:
(therapeutic use)

• Crohn disease; Ulcerative colitis; Juvenile idiopathic arthritis; Fistulising Crohn disease; Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Chronic plaque psoriasis; Hidradenitis suppurativa

Listing requested:

Please see PSD for more information

Funding program:

Please see PSD for more information

Request authority level:

Please see PSD for more information

PBAC Submission type:

New listing (Minor)

Comment:

Biosimilar

Other PBAC consideration:

--

Submission received for:

March 2020 PBAC meeting

Opportunity for consumer comment:

Open 24/12/2019 and close 12/02/2020 (see PBS Website)

PBAC meeting:

Held on 11/03/2020

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

16/10/2020

Lodgement of required documentation:

24/11/2020

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 30/11/2020

Status:

Finalised

Government processes:

Commenced on 01/02/2021

Medicine listed on the PBS:

01/04/2021 (see PBS schedule)