Many of the top selling drugs worldwide are biologics and many companies are seeking to produce biosimilars to compete in these lucrative markets. Activity relating to biosimilars is intensifying in the US following the introduction of the BPCIA and continues in Europe since the first biosimilars were authorised in 2006. Successfully bringing a biosimilar to market raises different challenges to small molecule generics and there are differences in the approach in the US and Europe.
Taylor Wessing and Willkie Farr & Gallagher hosted a series of three webinars covering various aspects of market access for biosimilars.
Biosimilars - an overview of the route to market in the US and Europe
- Basics of the regulatory system in the US and Europe
- History of approvals and launches in the US and Europe
- Overview of the "patent dance" under the BPCIA and contrast to the position in Europe
Biosimilars - interchangeability / substitution and advertising
- Access to market – how biosimilars are prescribed in the US, the UK, France, Germany and the Netherlands
- Issues relating to interchangeable biosimilars in the US
- Advertising rules in the US compared to the position in UK, France, Germany and the Netherlands
Biosimilars - pricing and reimbursement and the competitive landscape
- Overview of the pricing and reimbursement process in the US, the UK, France, Germany and the Netherlands
- Product launches – the line between competition and a breach of antitrust rules
Alternatively watch the full playlist here.