Despite the lack of progress in the regulatory situation in the US, the biosimilars sector is forging ahead as generic companies gain ground in this high-reward/high-risk business.

The future of the pharmaceutical industry lies with biotechnology. Biotech drugs account for around 10-15% of the current pharmaceutical market, and the sector is outperforming the market as a whole in terms of growth.

The issue of the manufacture, approval and marketing of generic biotechnology drugs has become a major source of debate within the industry for two main reasons:

1. Cost containment. Biotech products are expensive to develop, manufacture and administer, and becoming more expensive as newer, more complex treatments are developed. The availability of generics would spur competition and hopefully reduce prices.

2. Patent expiry. Patents in the USA and Europe on the older biotech drugs have either expired or will begin to expire over the next few years.

Manufacturers in Asian, Eastern European and Latin American markets have been selling biologicals for years. But it is the valuable Western markets that excite, and a number of new approvals in the EU are raising interest in the biosimilar sector.

And it's not just geographical expansion. Dr Reddy's have launched a biosimilar version of rituximab for the Indian market, the first monoclonal antibody to be so produced.
Providing…
A thorough review of the latest regulatory situation in the USA, Europe and selected markets worldwide

An examination of products that are currently available for development:
- EPO
- HGH
- G-CSF
- Human insulin
- Interferon

A review of key areas such as development costs, production and patent issues

A review of the work of over 30 companies actively developing biosimilar products The market may be developing but questions remain:

Will a significant biosimilar market develop?
Could an abridged regulatory process really benefit generic manufacturers?
Which companies are making the moves that are driving change?
Which therapies are now on the biosimilar radar? Biosimilars: a market coming of age? is a new, critical strategic management report which addresses these and other key issues of concern. The 175-page report is packed with authoritative statistics, case studies and detailed arguments on every aspect of the global biosimilar market and its potential.
“Given the combined logic of rising drug expenditure and the biological direction of drug development, it seems certain that for the generic industry to thrive it will need to contain a biosimilar element.”

The biosimilar sector continues to attract interest and controversy. Most generic manufacturers are actively involved in it, either directly or indirectly. The successful ones will be those with the patience, resources and above all money to invest now, in order to gain in the future. Even for the vanguard those gains are some years off but positive developments are being made.

USA: PROGRESS AT LAST?
The US badly needs to establish a regulatory framework for biosimilars. As the rest of the world moves on, the US has been bogged down in legislative initiatives that have come to nothing. But there could be light at the end of the tunnel. On June 22nd 2007 a bill was announced in the Senate to provide a pathway for FDA regulation of biosimilars. The Biologics Price Competition and Innovation Act of 2007 (S. 1695, or BPCIA), is the first to command significant bi-partisan support. In particular, Orrin Hatch is one of the sponsors of the new bill. This is an important move; Mr Hatch, one of the architects of the 1984 Hatch Waxman Act, had not supported previous moves in Congress. He has been trying to create a bill which balances the needs of generic companies with continued incentives for the originator industry, and felt that previous Democrat-led efforts had not done this.

EUROPE: EPO APPROVAL IS A SIGNIFICANT STEP
The settled regulatory regime in the EU has seen progress in new approvals, most notably that of biosimilar EPO. In August 2007, the EMEA approved biosimilar EPO for Sandoz and two partner companies. The approval represents a major advance for Sandoz and in September 2007 it was reported that the CEO of Sandoz, Andreas Rummelt, said that new EPO will be launched ‘in the coming weeks' in Germany and the UK, at a price discount of 25%-30%.

INDIAN COMPANIES LEAD EXPANSION WITH LAUNCH OF BIOSIMILAR MABs
If the biosimilar industry is going to progress beyond the first generation biologics then it needs to target more high profile therapies. For example, monoclonal antibiodies are a fast-growing biologic therapy area, and rituximab is one of the oldest, first having been approved in 1997. Sales of rituximab were worth US$3.8 billion to the developer Roche in 2006. It was to some industry surprise then when Dr Reddy's announced its version of the drug in its home market in April 2007 under the Reditux name. While it is the only such version in India and arguably the only ‘biosimilar' MAB in the world, the move demonstrates the progress made by the industry. In another move, Ranbaxy-backed Zenotech are conducting clinical trials on rituximab as part of their growing biosimilar portfolio.
Who's doing what, and with whom? Leading players assessed…
Anhui Anke Biotech
Barr Pharmaceuticals
Biocon
BioGeneriX
BioPartners
Bioton S.A.
Cangene
Cell Therapeutics
CIGB (Cuba)
Cipla
CheilJedang (CJ Corp)
Dr Reddy's
Dragon Pharmaceuticals
GeneMedix
Hospira
Inno Biologics
Intas Biopharmaceuticals
LG Life Sciences
Momenta Pharmaceuticals
NCPC Genentech
Pliva
Sandoz
SciGen
3SBio
Shenzhen Kexing Biotech
Stada Arzneimittel
Teva Pharmaceuticals
Viropro
Wockhardt
Zenotech

What's in a name?
What to call biosimilars has generated a whole controversy of its own. The term 'biogeneric' is a useful shorthand, but is not in favour with regulators or anyone else seeking a precise definition. To describe something as 'generic' implies a product that has proven bioequivalence with an originator drug. Even the generic industry now accepts that this is not quite possible for biologics; instead, regulators talk about proving a high degree of 'similarity'.

Hence the term 'biosimilar'. This is the official name given in the EU pharmaceutical directives. The USA, having no defined regulatory path for these products, has no firm terminology.