Summary
Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies - and some surprising names - are positioning themselves for market entry.
Description
Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies - and some surprising names - are positioning themselves for market entry.
Examining the market for companies
The need for a settled market environment is essential if the growing numbers of biologic products losing patent protection in the next 5-10 years is to be exploited. However, progress is painfully slow and critical issues driving the market dynamic include:
Industry investment: a sign of confidence?
This report provides a detailed analysis of 50 companies active in the biosimilars field, many of which have declared their interest in 2011. The move may reflect a growing confidence that as regulatory provision for biosimilars increases, and as the pipeline of prospective products matures, then the prospect of actually being able to launch products grows more realistic.
The US continues to disappoint; Europe forges ahead
Despite President Obama's health reform bill being passed in 2010, very little has happened. And the FDA's cautious approach suggests little will happen in the immediate future. The much anticipated Guidance, expected in 2011 has failed to appear, and in May 2011 FDA published details for User Fees - a scheme that will not come into effect
(assuming it is passed by Congress) until 2013. Given that an untried regulatory system will not operate at the fastest speed then prospects of a US market for advanced biosimilars seem remote before 2015. In contrast, European regulators are revising their widely-adopted regulations in the light of experience, with a view to issuing revisions and guidance in 2012.
Developing markets may offer a profitable alternative
Developing markets with rising disposable incomes may present the medium-term prospect for biosimilars, since they combine a large target population with reduced operating costs. Many countries are following the EU model of regulation. Markets such as India and China have plenty of home-grown production capacity. Some companies
have sought to turn this capacity to their advantage, and have signed deals with Chinese/Indian producers for the development of products to be sold around the world.
This report provides a comprehensive insight to the market environment,
current and future products and the companies involved.
A complete examination of the regulatory situation in the US, Europe and emerging markets
Detailed assessment of current biosimilar products and developers with market share by product
EPO
G-CSF
HGH
Human Insulin
Interferon (alfa & beta)
Identification and analysis of likely second wave of advanced biologics to come to the market
Adalimumab
Etanercept
Infliximab
Rituximab
Trastuzumab
A review of operational issues that will affect the adoption of biosimilars including pricing/reimbursement, clinician attitudes and patient acceptance
The position, activity, products, pipeline and plans of 50 leading players in the field
The Challenge for Industry
The development of a biosimilar presents a series of challenges to traditional generic drug manufacturers seeking to enter the sector. To succeed, a company must have good financial backing. Small companies will be able to do the science, but the cost of product development and approval will generally exceed the resources of most chemical generic organisations. After this, there is the cost of marketing and post-market surveillance. There is little prospect in the EU and USA of biosimilars being sold unbranded and biosimilar developers will have to pay for the branding and the marketing of the products; a task for which many lack the funds, sales force and experience.
Corporate manoeuvring is seeing the competitive landscape change
Despite the challenges there has been an upsurge in company activity, most notably from the branded industry and from companies who have no current significant pharmaceutical interests. With the regulatory situation generally favourable to the branded industry, why are they interested?
There are three broad reasons why an originator would wish to become involved with biosimilars. Firstly, it would create a more diversified portfolio, an important consideration in an era of near-dry pipelines. Secondly, it would potentially allow for the development of expertise in the biologic area for companies which traditionally have limited involvement in biologics. Thirdly, it could potentially act as a "spoiler" operation by making the market environment more difficult for smaller biosimilar developers.
Among recent corporate developments
Pfizer and Biocon announced a deal in October 2010 for the development and worldwide commercialisation of Biocon's recombinant insulin products.
Boehringer Ingelheim announced the establishment of a separate biosimilar business in September 2011.
Amgen and Watson announced a deal for the development of biosimilar versions of non-Amgen biologic products in December 2011.
Baxter and Momenta Pharmaceuticals announced a joint-venture for the development of biosimilars in December 2011.
Biogen Idec announced a joint-venture deal with the Korean conglomerate, Samsung, for the development of biosimilars. This will not include biosimilars of Biogen Idec products.
Fujifilm have indicated they will create a joint-venture for the development of biosimilars in 2012. Competitive Assessment
50 Leading players reviewed
3SBio
Actavis
Amgen
Avesthagen
Bioclones
Biocon
Biogen Idec
Biolex Therapeutics
BioPartners
Bioton
Boehringer Ingelheim
Cangene
Cell Therapeutics
Celltrion
CIGB
Cinnagen
Cipla
CJ Corp
Claris Lifesciences
Dr Reddy's
Elona Biotechnologies
Gennova Biopharmaceuticals
Getz Pharma
GTC Biotherapeutics
Hospira
Inno Biologics
Intas Biopharmaceuticals
Itero Biopharmaceuticals
LG Life Sciences
Merck & Co
MJ Biopharma
Momenta Pharmaceuticals
Mycenax Biotech
Mylan
Pfizer
Protalix
Reliance Life Sciences
Samsung
Sandoz
SciGen
Selexis
Shantha Biotechnics
Simcere/Shanghai Celgen
Stada Arzneimittel
Teva Pharmaceutical Industries
Three Rivers Pharmaceuticals
Viropro
Watson
Wockhardt
Zenotech Laboratories
Other reports and services in this sector are:
Biosimilars Business Review A quarterly round-up and review of the latest developments in this rapidly developing sector.
Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars (July 2011) The latest edition of Espicom's best-selling injectables report focuses on hospital drugs in therapy areas such as cancer, thrombosis, rheumatoid arthritis and serious infection. The report examines the status, value and generic/biosimilar opportunity for over 30 high-growth injectable drugs.
World Generic Markets Each issue of our fortnightly business publication World Generic Markets will keep you in touch with the latest news on the companies, products and alliances that are shaping the global generic markets.
Global Biosimilars: A return to optimism? published by Espicom Business Intelligence in January 23, 2012. This report consists of Pages: 200 and the price starts from US $ 2265.
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