Friday, June 15, 2012

An overview of the Global Biosimilar Market and the potential opportunity


Current Market Opportunity for Biosimilars
The global biosimilar sales in 2011 was $520m, of which 82% came from Ex-US markets, while 18% comes from the US.  Europe which has been a pioneer in approval of biosimilars, has approved 14 biosimilars medicines ‐ out of 18 submissions ‐ which correspond to three reference products: somatropin, epoetin alfa and filgrastim. The price of biosimilars is on average between 10 % and 35 % lower than the respective reference products (calculated on the list prices, which do not take into account the discounts and rebates often accorded by suppliers, especially to hospitals and other institututional buyers).

Anticipated Market Size for Biosimilars
Biologic sales up to $70b will lose patent exclusivity by 2017, leading to manifold expansion for the biosimilar opportunity.  Assuming a 20% market share, the potential market is still worth $14b for the biosimilar players.  65% of the biosimilar opportunity arising by 2017 will be driven by the EU/RoW market, and 35% in the US. Rituxan, Herceptin, Remicade, Insulins, Interferons, Humira, Novo Seven are the one’s which comprise a major proportion of the opportunity.  While biosimialrs for Herceptin may not be able to get a share, but Rituxan, Remicade and others are attractive targets. You will find a list of major biologics losing patent in the US at http://www.pharmaintellect.com/2011/04/biologics-patent-expiry.html

Of course, how significant the opportunity for biosimilars ultimately becomes will largely be driven by the regulatory pathways in key countries.
EU and Japan

Japan established its biosimilar pathway in March 2009 and  is very similar to the EU pathway in that they require a thorough comparability exercise to prove similarity to the reference product.  Japan like EU does not permit substitution of a biosimilar with it reference or innovator product. However, Japan requires that the comparability exercise be performed with reference product sourced in Japan. They do 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

EMA is close to pioneering guidelines regarding development of biosimilar monoclonal antibodies (mAbs).

US
US has proposed a step-wise approach 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. However  In case of immunogenecity, the USFDA may possibly require a complex clinical development. The draft guidelines are not addressing the details on demonstrating interchangeability. USFDA allows extrapolation across indication and potential use of a non-US comparator product is possible (bridging data required). USFDA also permits Interchangeability or substitution.

Who is best positioned to tap the biosimilar opportunity
Broad global presence with strong marketing & sales capability, first mover advantage, manufacturing capability positions Sandoz as the future leader in the biosimilar space. Sandoz is also  the current market leader with about 51% market share and has grown @ CAGR of 50% over the last four years.  Sandoz has three pipeline candidates : Zarzio® (filgrastim) US – Phase III, LA-EP2006 (pegfilgrastim) – Phase III, GP2013 (rituximab) – Phase II in rheumatoid arthritis and Phase III in oncology Ther are several other non-disclosed molecules in pre- and clinical development .