Paradigm Global Events is proud to present Biosimilars and Follow-On Biologics Americas 2013.

Biosmilars drugs are, in essence, the biological equivalent of generics for the biopharmaceutical sector. The issues with generic drugs are well known as they have been on the market for a number of years. However, biosimilars are only recently coming on the market as patents for the original innovator drug expires.

There are a number of challenges with biosimilar drugs: commercial, regulatory, and technical. This conference examines all of them in turn and discusses for example: the current usage of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at some of the regulatory issues surrounding the new US law on biosimilars and what this means for the issue of data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the key concern. Biological drugs by definition are produced with recombinant therapeutic protein: so a biosimilar has to be as well. However, no two cell lines are exactly the same, so biosimilar producers have to prove that the overall effects are the same. This can be done in a number of ways, this conference examines the use of mass spectrometry and quality by design.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximise opportunities.

Biosimilar drugs are, in essence, the biological equivalent of generics for the biopharmaceutical sector. The issues with generic drugs are well known as they have been on the market for a number of years. However, biosimilars are only recently coming on the market as patents for the original innovator drug expires.

There are a number of challenges with biosimilar drugs: commercial, regulatory, and technical. This conference examines all of them in turn and discusses for example: the current usage of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at some of the regulatory issues surrounding the new US law on biosimilars and what this means for the issue of data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the key concern. Biological drugs by definition are produced with recombinant therapeutic protein: so a biosimilar has to be as well. However, no two cell lines are exactly the same, so biosimilar producers have to prove that the overall effects are the same. This can be done in a number of ways, this conference examines the use of mass spectrometry and quality by design.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximise opportunities.