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Inclusions of new biologicals, 2018

Related information

23 July 2019

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.


Inclusions of new biologicals, 2018

December 2018

KYMRIAH

Evaluation commenced: 10 Apr 2018

Registration decision: 13 Dec 2018

Date registered: 19 Dec 2018

Approval time: 157 working days (255)

T cells - tisagenlecleucel, cryopreserved - T

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 is also 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.

August 2018

FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - EPIXL; FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - EPIBURN; FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - EPIFIX; FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - AMNIOFIX; FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - AMNIOFIX WRAP; FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - EPIFIX MESH; FOETAL MEMBRANES, DEHYDRATED, IRRADIATED - L - EPIXL FENESTRATED; FOETAL MEMBRANES, DEHYDRATED, MORSELLISED, IRRADIATED - L - AMNIOFIX INJECTABLE; FOETAL MEMBRANES, DEHYDRATED, MORSELLISED, IRRADIATED - L - EPIFIX INJECTABLE; FOETAL MEMBRANES, DEHYDRATED, MORSELLISED, IRRADIATED - L - AMNIOFIX SPORTS MED

Evaluation commenced: 20 Apr 2017

Registration decision: 7 Aug 2018

Date registered: 8 Aug 2018

Approval time: 177 working days (255)

Amnion tissue

Vicki Partridge Pty Ltd

Class 2 biological

This product is an amnion tissue indicated for the treatment of acute and chronic wounds to enhance healing. It is also indicated for the treatment of chronic plantar fasciitis to reduce pain and increase function.

May 2018

AMNIOTIC MEMBRANE, CRYOPRESERVED - L

Evaluation commenced: 29 Mar 2016

Registration decision: 17 May 2018

Date registered: 18 May 2018

Approval time: 179 working days (255)

Amnion tissue

South Eastern Sydney Local Health District

Class 2 biological

This product is an amnion tissue indicated for the treatment of ophthalmic disorders, disease or trauma, or as a wound dressing.

SKIN, SPLIT, CRYOPRESERVED - L

Evaluation commenced: 4 Apr 2016

Registration decision: 17 May 2018

Date registered: 18 May 2018

Approval time: 170 working days (255)

Skin tissue

South Eastern Sydney Local Health District

Class 2 biological

This product is a skin tissue indicated for the repair, replacement and regeneration of lost or damaged skin.

February 2018

TENDON, FROZEN - L; MENISCUS, FROZEN - L; TENDON, FREEZE DRIED - L; BONE, SEGMENTED, FROZEN - L; BONE, MORSELLISED, FREEZE DRIED - L; FASCIA LATA, FROZEN - L; BONE, SEGMENTED, FREEZE DRIED - L; TENDON WITH BONE, FREEZE DRIED - L; BONE, MORCELLISED, DEMINERALISED, FREEZE DRIED - L; FASCIA LATA, FREEZE DRIED - L; TENDON WITH BONE, FROZEN - L; MENISCUS WITH BONE, FROZEN - L

Evaluation commenced: 29 Sep 2016

Registration decision: 2 Feb 2018

Date registered: 2 Feb 2018

Approval time: 240 working days (255)

Musculoskeletal tissue

ConMed Linvatec Australia Pty Ltd

Class 2 biological

This product is a musculoskeletal tissue indicated for the treatment of musculoskeletal disorders, disease or trauma.

DERMIS - L - ALLOPATCH HD; DERMIS, FREEZE DRIED - L - ALLOPATCH HD

Evaluation commenced: 29 Sep 2016

Registration decision: 2 Feb 2018

Date registered: 2 Feb 2018

Approval time: 218 working days (255)

Skin tissue

ConMed Linvatec Australia Pty Ltd

Class 2 biological

This product is a skin tissue indicated for the replacement of damaged or inadequate integumental tissue, or reinforcement of soft tissue defects.