“The Age of Biosimilars” is the term which was used by Sandoz representatives in Generics and Biosimilars Strategies EMEA Conference in Istanbul.
Dr. Michael Muenzberg, who is the Head of Medical Affairs at Sandoz Biopharmaceuticals, made a presentation about biosimilars terminology and Chrys Kokino, the Head of Global Marketing, explained the opportunities and challenges in this fast growing area.
Dr. Muenzberg’s presentation started with the well-known slide, which shows the molecule sizes of aspirin, filgrastim, epoetin alpha and a monoclonal antibody which is about 150 kilodaltons. This comparison chart is widely used both by biosimilar manufacturers and originators:
Originators try to show the complexity of the molecules and tell the audience that it’s impossible to make copies of their own products. On the contrary, biosimilar players use this slide to show that, aspirin was founded more than a hundred years ago and they now have the capability to make the copies of the original highly-complex products.
REGULATORY: Biosimilar is not a scientific definition, it is a regulatory term introduced by the EMA Dr.Muenzberg added. It is a term which describes the products which are approved under the regulatory pathway and the products which are not approved by this pathway, should not be named “biosimilars”.
A biosimilar is clearly not a generic and “biogenerics” is a wrong term. Biosimilars are successors of an original biopharmaceutical but due to complexity of the molecules, the term “generic” can not be accepted.
SIMILARITY: As a representative of one of the biggest players in this industry, Dr. Muenzberg presented some results of the technical changes (variations) which the originators made. According to the 2008 EPAR variations report, Amgen, the manufacturer of darbepoetin alfa (Aranesp), made a change in the “Master Cell Bank” but this showed similar results to the previous approach…
After Amgen’s change in the Master Cell Bank, the product showed a 25% higher AUC (Area Under the Curve) in single dose study in dogs. Additionally, the product showed higher antibody response in dogs and it had comparable quality attributes and pharmacodynamics. Human safety, efficacy and immunogenicity results were all comparable.
Although Amgen, the originator of Aranesp, made lots of changes to their product with this variation, this product is not a new one and is still used as Aranesp, Dr. Muenzberg added. With this example, he tried to emphasize that, showing comparable results to the originator, is sufficient to be evaluated as “similar“.
MARKETING: The opportunities and challenges in biosimilars was presented by an another Sandoz representative, Chrys Kokino.
After showing some well-known facts about the biopharmaceutical markets, 2015 figures of the market and upcoming patent expiries, Mr. Kokino highlighted some challenges for biosimilars companies which are;
– Uncertain regulatory & legal environment (particularly in the US)
– Significant time, resources and expertise
– Need access to cost efficient and high quality manufacturing capacity and expertise
– Complex commercial environment with multiple stakeholders and strong competitors
Mr. Kokino finished his presentation by showing some figures after Sandoz products’ (filgrastim& epoetin alfa) launch in the EU countries.
Reference: Muenzberg M. The Age of Biosimilars: Biosimilars, biobetters, Follow On Biologics – Which is it? – Kokino C. The Age of Biosimilars: Opportunities & Challenges; Generics and Biosimilars Strategies EMEA Conference; 2011 Sept 28; Istanbul, Turkey.