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

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

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 […]

Global Development of Biosimilars

The major regulatory challenge for biosimilars is to prove that there are sufficiently similar to the innovator biologic such that the safety and efficacy are comparable. The similarity of two molecules is determined using the comparability exercise with four key parameters being addressed: safety, efficacy, quality and biological activity which are established. The choice […]

By |January 27th, 2015|Biosimilars|0 Comments

FDA’s Move towards Interchangeability for Biosimilars

The issue of interchangeability for biosimilars has been a pivotal one for which the FDA has made headway with the introduction of the ‘Purple Book’.

The FDA has long had the ‘Orange Book’ which describes all the registered medicines which are chemical entities and their corresponding generic(s). The Orange Book services two useful functions: denoting […]

By |September 11th, 2014|Biosimilars|0 Comments