Sandoz, a member of the Swiss giant Novartis group, is a worldwide leader in generics. The company has a history for more than 120 years and offers a broad portfolio of high-quality affordable medicines.
Sandoz was also the first company who was “fighting” for biosimilar approvals. They had long discussions and approval procedures for their first biosimilar, Omnitrope and this is why, they consider themselves as “pioneer” of biosimilars.
Sandoz has more than 10 major development centers and also more than 30 manufacturing sites worldwide and they are present in 130 countries1.
As a pioneer of biosimilars, Sandoz has a specific biosimilars website which can be accessed from here. In this website, Sandoz gives the description of biologics and also the biosimilars, the importance of these medicines2. Also you can find some information about the development and regulatory procedures of biosimilars in their website.
According to Sandoz biosimilars website, Sandoz is the global leader with 2010 sales of USD 185 million, representing nearly 50% of the worldwide regulated market.
In 2006, the first-ever biosimilar was launched in the EU (somatropin) by Sandoz, followed by the erythropoietin alfa in 2007 and G-CSF in 2009. Currently Sandoz is the only company with 3 marketed biosimilars in Europe.
Additionally somatropin biosimilar is marketed in US, Canada, Japan and Australia; it is approved under diffrerent regulatory pathways in these countries.
According to Sandoz press releases, Sandoz is focused on monoclonal antibodies and they declared that, Phase II study in rheumatoid arthritis for biosimilar rituximab has started at the beginning of this year.
Sandoz, as a member of Novartis group, has extensive synergies with other Novartis divisions and this makes them well experienced in modeling and simulation of clinical trials. Also manufacturing of biopharmaceuticals is not something new for Sandoz; they have been involved in this business for several years (starting before the Sandoz & Ciba-Geigy merger in 1996) and this makes them strong in biosimilars business.
According to Sandoz, although they are the world leader in biosimilars business, there are still a number of challenges across geographies, which are:
- The uncertain regulatory and legal environment in many countries and regions
- Significant development investment requirements in terms of time, resources, and expertise
- The need to access cost efficient and high quality manufacturing capacity and expertise
- The complex commercial environment, with stakeholders including competitors, regulators, payors, physicians, pharmacists, and patient groups
- Powerful originator competition