Biologicals and Biopharmaceuticals

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since the original guidance document was published in 2006, there are a number of changes under consideration in the draft guidance document ‘Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins’[i].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

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

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

The Challenges of Immunogenicity

One of the big issues facing biotherapeutics is potential for generation of unwanted immune response. Biologicals have a propensity to elicit immune responses as a consequence of many factors including being protein-based macromolecules. Immunogenicity is relevant for both proteins and peptides including those generated by recombinant DNA technology as well as synthetic peptides. For […]

Regulatory Evaluation of Biosimilars

The first challenge with understanding the regulation of biosimilars is to recognise the broad array of terminology which is used i.e.

Similar Biological Medicinal Product (SBMP) (the term used by the European Union);
Follow On Biological (the term initially used by the FDA);
Subsequent Entry Biologics (the term used by Health Canada);
Similar Biotherapeutic Product (the term used […]

Tissue and Cell Therapies

The TGA introduced the Biologicals Regulatory Framework in 31 May 2011. This new regulatory guidance had a three year transition which finished in May 2014. There is some confusion with regard to the terminology – ‘biologicals’ by the TGA definition include human tissue and cell therapies which are termed Advanced Therapies in other jurisdictions […]

By |October 13th, 2014|Biologicals and Biopharmaceuticals|0 Comments

Cell Banks: the Foundation of Biotechnology/Biological Products


By |October 10th, 2014|Biologicals and Biopharmaceuticals|0 Comments

The Challenges of Regulating Biologicals

There are significant challenges in the regulation of biologicals, as compared to chemical entities, for the following reasons:

Biologicals are derived from living matter – be it a blood product which is extracted from plasma or a recombinant protein which is produced from a bacterial or mammalian cell. Consequently, biologicals are both complex and inherently […]

By |September 9th, 2014|Biologicals and Biopharmaceuticals|0 Comments