1. In Vivo
  2. >>Archive

Biosimilars: The Time Has Come

Biosimilars' time has come--in Europe, at least. The European regulators asserted during a workshop in Paris at the beginning of December that biosimilars guidelines will be finalized before mid-2006. This will open up a market which could be worth $8 billion within five years in the EU, according to the European Generic Association (EGA).

In Europe, at least. This was the subtext of a joint workshop organized by the European Medicines Agency, EMEA, and the Drug Information Association in Paris at the beginning of December. The event brought together all stakeholders in the biosimilars debate—innovators, generic firms, regulators, physicians and patient groups--to discuss remaining areas of uncertainty in the draft guidelines on the development and approval of biosimilars, which EMEA issued last year. (See "Biosimilars: EMEA Wants Approvals," IN VIVO, September 2005 Also see "Biosimilars: EMEA Wants Approvals" - In Vivo, 1 September, 2005..)

There was plenty to discuss. Well before the exchanges were complete, however, EMEA asserted that the guidelines will be finalized...

More from Archive

More from In Vivo

Deals In Depth: June 2025

 
• By Deanna Kamienski and Maureen Riordan

Five $1bn+ alliances were penned in June, and four exceeded $2bn.

Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
• By Jung Won Shin

Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Podcast: Oxolife’s Agnés Arbat, Winner Of The European Prize For Women Innovators

 
• By Jo Shorthouse

Agnès Arbat, CEO of Oxolife and winner of the EU Women Innovators Prize, joins In Vivo to discuss OXO-001, a novel non-hormonal treatment aimed at improving embryo implantation in IVF. She shares insights from her biotech journey and the future of fertility innovation.