Regulatory Affairs in Biosimilars: EU vs US
09 Jul 2014 - 09 Jul 2014 - WEBINAR
This webinar is dealing with the recent regulative initiatives on the biosimilar pharmaceutical products market in Europe and United States. By the end of this decade, a significant number of blockbuster drugs will go off patent, allowing a large number of biosimilar products to enter the market. Regulatory developments favoring the biosimilar market are expected to boost the profits and market share of the companies involved.
It's important to devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are stacked against the enormous potential for increased profit margins. Clearly navigable regulatory pathways are essential for this outcome.
Our well-known speakers will focus on the comparison of regulatory affairs in biosimilars & biobetters in EU and USA, process for gaining scientific advise from FDA and EMA and comparability of a product during development vs the demonstration of biosimilarity from the EU vs US regulatory perspective.