Biosimilars and Sandoz: Insights from Novartis

June 26, 2012 12:30 PM

Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland, ranking number two in sales (46.806 billion US$) among the world-wide industry in 2010. 

Novartis was created in 1996 from the merger of Ciba-Geigy and Sandoz Laboratories, both Swiss companies with long histories. The pharma giant decided to go into the generics business and in 2003, Novartis created a subsidiary that bundles its generic drug production, reusing the predecessor brand name of Sandoz.

The company issued an Investor Insights report last week and we wanted to summarize some major parts of this report for our readers:

Novartis starts with stating that, biosimilars are back in the news, in the U.S for sure. The market opportunities are growing around the world and based on these results biosimilars are a clear target for the company.

Novartis is an innovator company, focusing on addressing unmet medical needs but as described above, the generics unit of the company, Sandoz is a pioneer in biosimilars area. Till today, the company is the world leader in developing, manufacturing and commercializing biosimilars and according to Novartis, Sandoz is well-positioned to capture the near- and long-term opportunities from biosimilars:

Development expertise
– Pioneer – developing biosimilars since 1996
– 8-10 molecules in development, including monoclonal antibodies (mAbs) with multiple clinical trials ongoing (e.g. rituximab)
– Novartis therapeutic area expertise in pharmaceutical clinical development – especially in oncology (collaboration underway on various clinical trials between Sandoz and Novartis Oncology Business Unit)

Manufacturing experience
– Producing recombinant proteins in the EU since 1980
– Industry-leading capabilities across Novartis: microbial, cell culture & fill/finish
– Share manufacturing expertise, capacity and talent across Novartis Group

Commercial experience
– Market leader with around 50% of the global biosimilar market (includes all biosimilars approved in the highly regulated markets of Europe, US, Canada, Japan and Australia)
– Broad global presence with strong marketing & sales capability (marketing biosimilars in ~50 countries)
– Continue to occupy #1 biosimilar position across all three marketed products (Omnitrope, Binocrit/outside the US and Zarzio/outside the US)
– Unparalleled market experience with over 50 million patient exposure days for the three marketed Sandoz products
– Ability to leverage Novartis Group experience and capabilities in public affairs, market access and commercial operations in countries where Sandoz does not have a strong presence

Sandoz pipeline
Sandoz is developing Zarzio, filgrastim biosimilar for the US; the product is in Phase III trials. Plus, the company has pegfilgrastim, the biosimilar of Amgen’s Neulasta in Phase III trials.

Sandoz’s rituximab biosimilar, an another attractive product, is also in clinical trials – Phase II in rheumatoid arthritis and Phase III in oncology.

Worldwide status
Novartis’ report confirms the worldwide leadership of European Union in the area of biosimilars. EMA has an established pathway since 2004 and this has led to the approval of 14 biosimilars to date.

In the US, the FDA draft guidelines provide sufficient flexibility to allow for a science-based approach to develop biosimilars, says Novartis. The company supports the following key elements of the draft guidelines:

  • The proposed step-wise approach (in-line with Sandoz’s own Biosimilar Concept) and the use of physicochemical and biological data to develop a molecule with overlapping characteristics to the originator (termed “highly similar”)
  • Comparative PK/PD data may be sufficient to establish biosimilar efficacy under certain conditions
  • Extrapolation across indications that share Mechanism of Action is possible
  • The potential use of a non-US comparator product is possible (if appropriate bridging data is submitted)
  • Interchangeability or substitution may be possible

Sandoz views the following as key challenges in the draft FDA biosimilars guidelines that will need to be addressed:

  • A possibly complex clinical development path with immunogenicity and dose response studies
  • The requirement to address pediatric studies for non-interchangeable biosimilar products; thus potentially lengthening and adding an additional hurdle to the development process
  • Guidance related to interchangeability is virtually absent in the draft guidelines

Japan, the third largest market in the world, established its biosimilar pathway in March 2009. It is very similar to the EU pathway in that they require a thorough comparability exercise to prove similarity to the reference product. However, Japan requires that the comparability exercise be performed with reference product sourced in Japan.

Japanese Health Authority does accept clinical data with foreign-sourced product provided:
a) Analytical data exists to prove similarity to the Japanese reference product
b) There is a bridging study (Phase I) done in the Japanese population

Novartis’ report indicates that, to date, Sandoz’s Omnitrope and one epoetin-alfa product are the only biosimilars approved in Japan.

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  Sources: Novartis, Wikipedia

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