Biosimilars Forum
The rise of Biosimilars has provided challenges and opportunities in equal measure for innovators and applicants. EMA guidelines have already led to a wave of approvals and with a host of other biologics going off-patent in the next few years there are surely more to follow. Many complex big molecule products are not yet viable candidates for biosimilars but progress in advanced technologies means that it is only a matter of time. Whilst Europe enjoys a relatively progressive approach to biosimilar approval, a lack of appropriate legislation in the United States has left a black hole waiting to be filled. When the FDA finally publishes guidelines the whole regulatory landscape will change.
There are many questions that both innovators and biosimilar applicants are looking to answer: How should comparability of products be measured? What is an acceptable level of data exclusivity and information exchange? What are the clinical implications of demonstrating novelty? If you are looking for answers, then this is an opportunity to find them.
C5’s Biosimilars Forum will bring together a leading faculty of expert speakers with different perspectives and backgrounds. A series of exclusive presentations will help innovators to understand what future developments in legislation might mean for their products. They will also help applicants who want to expand their knowledge of barriers blocking the pathway to approval. Use this opportunity to benchmark your practices and pick up critical knowledge from industry associates, regulators and service providers. When the event is over you can walk away with practical business solutions and an increased knowledge base, helping you to set a decisive agenda in uncertain times.
Topics to be covered include:
- Overview of biosimilar technologies and their potential for more advanced products
- Comparison of the legislative and regulatory frameworks in Europe and the United States
- Patent litigation requirements and addressing due diligence on both sides
- Achieving cooperation between the innovator and the biosimilar maker
- Taking the leap from developing a biosimilar to developing a biobetter
- Setting parameters for data exclusivity
- The extent to which SPCs can be exploited by innovators
Tags: CLE, legal conferences, Legal Events
