|[August 23, 2013]
Research and Markets: Biosimilar Opportunities in an Evolving Market
DUBLIN --(Business Wire)--
Research and Markets (http://www.researchandmarkets.com/research/r3k8s9/biosimilar)
has announced the addition of the "Biosimilar
Opportunities in an Evolving Market" report to their offering.
The long awaited promise of biosimilars takes another step to
fulfillment with the first approval in Europe of high-value second
generation products. But what products can be expected to follow, who is
developing them and what are the hot prospects? This report will answer
your key market questions.
- At the end of June 2013, the European Medicines Agency's Committee for
Medical Products for Human Use issued a positive opinion for the first
biosimilar version of Johnson & Johnson's infliximab for the treatment
of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.
- For the two successful applicants, Celltrion and Hospira, this
development passes a significant milestone for the whole biosimilar
sector as the products are the first monoclonal antibody (mAb) therapies
to reach a positive opinion following review via the EMA (News - Alert) biosimilars
regulatory pathway. This is an important event hich heralds a new era
of lower-cost biological therapies in Europe.
- For J&J and its partners, the news is less welcome. Already under
pressure from branded competitors in the TNF inhibitor market, it is no
surprise that both developer and biosimilar companies will be assessing
what share they may secure of its US$6.13 billion revenues.
- While significant for J&J, infliximab is just the tip of the iceberg
when it comes to the potential for biosimilars. In terms of revenue, six
of the top ten pharmaceutical therapies are biological products, which
have been targeted by biosimilar developers. These products had combined
global sales of US$41.4 billion in 2012. Also of significant importance
to biosimilar developers, with sales of US$4.2 billion in 2012 is
Amgen's Enbrel (etanercept).
- It may have taken a while, but the world's major pharmaceutical
originators have recognised the potential for biosimilars. A number have
disclosed their intentions and/or announced clinical trials in recent
- In any analysis of the pharma industry the US looms large - but not in
biosimilars. The painfully slow progress to a regulatory pathway for
biosimilars - still untried - has handed the initiative to others.
- The EU biosimilar regulations have been imitated widely in other
countries, while the emphasis of biosimilar research sits firmly in
Asia, notably India, China and South Korea. Of course, the big prize for
all biosimilar manufacturers is the US market, which accounts for
approximately 50% of the global value.
Key Questions Answered
- Where is less competition to be found in the first phase of
biosimilars in Epoetin and G-CSF?
- Biosimilars are more widely available in emerging markets - what
lessons can be learnt?
- What are the latest State regulatory developments in the US and will
they help or hinder?
- Which are the companies to watch, and why?
- Six companies are targeting Abbvie's Humira, who are they and what is
the status of their research?
For more information visit http://www.researchandmarkets.com/research/r3k8s9/biosimilar
About Research and Markets
Research and Markets is the world's leading source for international
market research reports and market data. We provide you with the latest
data on international and regional markets, key industries, the top
companies, new products and the latest trends.
[ Back To Technology News's Homepage ]