Monthly Archives: %sSeptember 2014

Orphan Drugs

Drugs which are developed for rare conditions are termed orphan drug and may be a medicine, vaccine or in vivo diagnostic agent.

In the early 1980’s it was recognised that there were a significant number of diseases which effected small patient populations and that the economics of developing drugs for these niche indications were unfavourable. […]

By |September 25th, 2014|Drug Regulation|0 Comments

Method of Manufacture Changes for Biologicals/Vaccines

Biologicals, including the products of recombinant technology and traditional vaccines, are the product of living cells. Because of this, seemingly inconsequential changes, such as feed rate, pH, stirring rate or temperature can have a profound effect on the proteins, including antigens, which the cells produce. Therefore, although many changes to the method of manufacture […]

By |September 15th, 2014|Manufacturing|0 Comments

Registration of Generic Medicines with the TGA

Generic medicines are those products which are ‘essentially similar medicines’ to the innovator. To qualify as a generic, it is necessary to have the same quantitative and qualitative composition for the active substance, the same pharmaceutical form and to show bioequivalence. If these conditions are met, generic medicines can piggy-back on the innovator’s scientific […]

By |September 12th, 2014|Generic Medicines|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

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

Traditional vs. Novel Biological Therapies

It’s a fascinating time to be a biologist interested in the development of novel biological therapies. The list of new products and potential possibilities is seemingly endless. In this blog I’ll compare the old school vaccines against a novel vaccine which relies on recombinant DNA technology.

Traditional biologicals, such as diphtheria and tetanus vaccines, are […]

By |September 8th, 2014|Biologicals and Biopharmaceuticals|0 Comments

What constitutes a medicine?

There are a plethora of different types of therapeutic goods including biologicals, biopharmaceuticals, chemical entities, herbal medicines, generics, biosimilars and medical devices. My particular interest is in prescription medicines especially those which are biologically derived. This covers a broad array of therapies including traditional vaccines and blood products plus the novel biopharmaceuticals such as […]

By |September 3rd, 2014|Biologicals and Biopharmaceuticals|0 Comments

Risk based approach to drug regulation

There are over 73,000 registered, listed and included medicinal products on the Australian Register of Therapeutic Goods (ARTG). With this large number of therapeutic goods it makes sense that the Therapeutic Goods Administration (TGA) uses a risk-based approach to the regulation of medicines.

Those products which are considered higher risk, such as prescription medicines (termed […]

By |September 2nd, 2014|Drug Regulation|0 Comments