Europe pharma companies benefiting from strict US approval process

Europe could be stealing the US" thunder when it comes to gaining regulatory drug approval for Biosimilar products.

According to a new report on the subject, the US still needs key legal clearance before it can gain approval from the Food and Drug Administration (FDA), whereas five biosimilar products have already been approved in Europe.

"Biosimilars Series - Regulatory And Development Issues" from UK-based online store Report Buyer says skyrocketing healthcare costs and expenditure on biologics have encouraged US 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 known as biogenerics, follow-on proteins or follow-on biologics in the US. 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 US legislation pertaining to the regulatory approval of biosimilars. They also point out that US 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 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.