October 18, 2007 07:25 ET

U.S. Regulatory Delays allows Europe to lead the Biosimilar Pharmaceutical Race

LONDON, UNITED KINGDOM--(Marketwire - Oct. 18, 2007) - Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report which says Europe is far ahead of the U.S when it comes to approving the use of biosimilars. It also analyses the issues and legislation surrounding the use of biosimilars in both regions.

"Biosimilars Series - Regulatory And Development Issues" finds that while five biosimilar products have already been approved in Europe, the US still needs key legal clearance before it can gain approval from the Food and Drug Administration (FDA).

The report says skyrocketing healthcare costs and expenditure on biologics have encouraged U.S lawmakers to propose three different bills this year alone formulating a statutory pathway for the approval of biosimilars. Industry analysts, however remain doubtful about whether legislation will be passed by the end of this year which would pave the way for clearance on biosimilars from the FDA.

Biosimilars are also called biogenerics, follow-on proteins or follow-on biologics in the U. S. They are generic versions of biotechnology products. The study points out that since biosimilars are made in living organisms and manufacturing processes are trade secrets, generic versions of biologics cannot be kept identical to their reference products. In this regard, they are not true generics and need to get treated differently from generics of small molecule drugs.

Europe adopted a new directive in 2004 outlining the legal area for the approval of biosimilars. Even though the law itself is very basic, its main goal was to endow the European Medicine Evaluation Agency (EMEA) authority to approve biosimilars based on their scientific guidelines and requirement.

Industry analysts say political issues and the uneasy relationship between innovators and generic companies have delayed formulation of key U. S legislation pertaining to the regulatory approval of biosimilars. They also point out that U.S legislation is much more detailed than the EC directive as it addresses issues such as market exclusivity and patent litigation. It also proposes that the FDA is given freedom on setting requirements to approve biosimilars. The report says the FDA is widely expected to be led by EMEA's precedents in the matter.

Authors of the report analyses the possible impacts of important bills becoming laws in the U.S. They take into account the effect the benefits of potential one-year exclusivity the first biosimilar producer can receive and its influence on the commercial success of biosimilars. The study also looks at the legal framework allowing the creation of a highly litigious environment which could deter smaller players and result in lowering the possibility of price discounts in the market.

"Biosimilars Series - Regulatory And Development Issues" is available from Report Buyer.
For more information go to: http://www.reportbuyer.com/go/DAT07264

Report Buyer product ID: DAT07264
About Report Buyer.

Report Buyer is a UK-based independent online store supplying business information on major industry sectors. These include the Automotive Industry, Banking & Finance, Energy & Utilities, Food & Drink, Telecoms and Pharma & Healthcare. The website now carries over 40,000 business information products, including market reports, studies and books. Report Buyer is the intelligent way to buy market research making it an essential resource for executives and information buyers worldwide. Subscribers receive a free monthly newsletter and email alerts on new titles in their areas of interest. A regularly updated blog provides information on the latest market trends.

"Biosimilars: Regulatory Issues, Europe continues to make strides while the US lags behind" is available in pdf format from Piribo. For more information, go to:

Piribo product ID: DAT625

About Piribo.
Piribo (http:www.piribo.com) is a UK-based independent online store supplying business information on the pharmaceutical and biotechnology industries. The website now carries over 6,000 English language titles including, market reports, studies and books and is the UK's largest online biopharma information store. Subscribers receive a free monthly newsletter and email alerts on new titles in their areas of interest. The company was established in 2004.

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