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About Penny Field

Penny Field has worked in the pharmaceutical industry for 25 years; the past 23 years have been focused on the development and registration of medicinal products. Penny has consulted on the regulatory strategy and development of monoclonal antibodies, immunotherapeutics, recombinant proteins, gene therapies and biosimilars. Additionally Penny has experience in the registration of New Chemical Entities (NCE) and generics. She has prepared Investigational New Drug (IND), Clinical Trial Exemption (CTX) and Marketing Applications for recombinant proteins, vaccines, NCE, generics and blood products.

Expedited Pathways

Draft process flow of expedited pathway: reproduced from the TGA Presentation ‘Prescription Medicines MMDR Reforms Overview and Designation Process: Expedited Pathways for Prescription Medicines’, 14 October 2016 

 

One of the outcomes of the ‘Review of Medicines and Medical Devices (MMDR Review)’ is the adoption of expedited pathways for approval of prescription medicines in Australia.

The TGA […]

By |October 18th, 2016|Drug Regulation|0 Comments

Updated TGA Guideline on the Regulation of Biosimilars

The TGA has recently released their updated guidance on the ‘Regulation of biosimilar medicines’ v 2.0, Dec 2015. A few preliminary thoughts:

The section on Reference Medicines has been updated. In order to register a biosimilar in Australia the reference product must be a biological medicine which is registered in Australia on the basis of […]

By |January 22nd, 2016|Uncategorized|0 Comments

Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)

In light of experience, since the original guidance document was published in 2006, there are a number of changes under consideration in the draft guidance document ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’[i].

Broadly these include:

More specific requirements for immunogenicity assays
Investigation into the clinical significance of immunogenicity
Risk-based approach to immunogenicity with requirements for both […]

CMC Development of Biosimilars

 

In order to establish biosimilarity to the innovator biopharmaceutical (reference product) it is necessary for the product to be highly comparable to the reference product from the region in which approval is ultimately sought.

A stepwise approach is recommended by firstly establishing that the CMC aspects are highly comparable to the reference product. For example:

The […]

By |November 26th, 2015|Uncategorized|0 Comments

The Trans-Pacific Partnership and Biological Medicines

The Trans-Pacific Partnership (TPP) has reached agreement; consequently a major sticking point in relation to the period of data exclusivity for biological medicines has been overcome. The innovators of biological medicines were pushing for a 12 year data exclusivity period in-line with the US legislation. It is argued that this timeframe is required to […]

By |October 7th, 2015|Biologicals and Biopharmaceuticals, Biosimilars|0 Comments

Traversing the valley of death: regulatory challenges in the transition from discovery to development

The transition from drug discovery to drug development is aptly termed the ‘valley of death’. Its earned this name due to the difficult journey, and high failure rate, between these two major activities. This journey can be exacerbated if there is a cultural divide between discovery, which often occurs in an academic environment, and […]

By |September 15th, 2015|Drug Development|0 Comments

Approval of Infliximab Biosimilar in Australia

Registration of Hospira’s infliximab biosimilar, Inflectra, marks the first approval of a biosimilar monoclonal antibody by the Therapeutic Goods Administration. In order to achieve this approval Inflectra has demonstrated that it is biosimilar to the blockbuster drug, Remicade.

The PBAC subsequently listed Inflectra for the same indications as Remicade which is used in the treatment […]

By |August 24th, 2015|Biosimilars, Uncategorized|0 Comments

European Guidance with regard to Biosimilar Recombinant G-CSF

The European Medicines Agency (EMA) released a concept paper on 23 July 2015 with regard to revising the biosimilar guidance document on biosimilar recombinant granulocyte-colony stimulating factor (rhG-CSF).

The current EMA guidance document came into effect in June 2006 and consequently was one of the earliest European product specific guidance for biosimilars. The passage of […]

Safety of biosimilar medicines

On 18 June 2015, Australia’s reimbursement agency the Pharmaceutical Benefits Advisory Committee (PBAC) released a statement entitled ‘Safety of biosimilar medicines’. In this statement, the PBAC recommended allowing the substitution of biosimilar drugs by clinicians and pharmacists – if the biosimilar is proven to have the same safety and efficacy as the innovator drug. […]

By |June 19th, 2015|Biologicals and Biopharmaceuticals, Biosimilars|0 Comments

Gene Therapies

Gene Therapy Medicinal Products (GTMP) cover a broad array of different technologies and product types. The purpose of such therapies is to deliver a genetically engineered construct which will express either a therapeutic sequence or protein to enable the repair, regulation, addition or deletion of a gene sequence. The overall aim being to regulate […]

By |May 30th, 2015|Biologicals and Biopharmaceuticals|0 Comments