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Inclusions of new biologicals

14 July 2021

Each year, TGA approves new biologicals for inclusion in the Australian Register of Therapeutic Goods (ARTG).

The decision to approve a new biological comes after a comprehensive review by TGA scientists and clinicians of the product’s quality, safety and efficacy of the proposed use of the biological. TGA classifies biologicals according to the level of risk to patients associated with their use and may be either Class 1 (lowest risk), Class 2, Class 3, or Class 4 (highest risk) biologicals.

The trade name, active ingredient, type of cell or tissue, and sponsor for each new biological reflects the information initially included in the ARTG.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, time allocated to the sponsor to respond to requests for information, and 'mutual clock stop' periods agreed with the sponsor.

From 2018, approval times are reported in the number of TGA working days for each decision, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.

Class 1 biologicals only require a statement of compliance to be included in the ARTG and so are only reported with a date of registration.


Previous years

2020 2018

Inclusions of new biologicals, 2021

May 2021

FAECAL MICROBIOTA TRANSPLANT (FMT)

Evaluation commenced:

Registration decision:

Date registered: 24 May 2021

Approval time: N/A

Faecal microbiota, frozen - L - Restoba; Faecal microbiota, freeze-dried, encapsulated, frozen - L - Restoba

Centre for Digestive Diseases Pty Ltd

Class 1 biological

This product is a faecal microbiota transplant (FMT) product indicated for the restoration of gut microbiota.

FAECAL MICROBIOTA TRANSPLANT (FMT)

Evaluation commenced:

Registration decision:

Date registered: 21 May 2021

Approval time: N/A

Faecal microbiota, frozen - L

Campbelltown Private Hospital

Class 1 biological

This product is a faecal microbiota transplant (FMT) product indicated for the restoration of gut microbiota.

February 2021

REVITA

Evaluation commenced: 13 Feb 2019

Registration decision: 25 Feb 2021

Date registered: 26 Feb 2021

Approval time: 253 working days (255)

Foetal membranes, freeze-dried, irradiated - L - Revita

Surgical BioFix Ltd

Class 2 biological

REVITA is to be used as a wound covering, or barrier membrane over chronic and acute wounds, including dermal ulcers or defects.

KYMRIAH

Evaluation commenced: 20 Oct 2020

Registration decision: 5 Feb 2021

Date registered: 11 Feb 2021

Approval time: 45 working days (255)

T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah

Novartis Pharmaceuticals Australia Pty Ltd

Class 4 biological

KYMRIAH is a genetically modified autologous immunocellular therapy indicated for the treatment of paediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in second or later relapse.

KYMRIAH

Evaluation commenced: 20 Oct 2020

Registration decision: 5 Feb 2021

Date registered: 11 Feb 2021

Approval time: 45 working days (255)

T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah

Novartis Pharmaceuticals Australia Pty Ltd

Class 4 biological

KYMRIAH is a genetically modified autologous immunocellular therapy indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah is not indicated for patients with primary central nervous system lymphoma.