Comparator Sourcing: Leveraging The Bolar Exemption To Accelerate Market Access For Generic And Biosimilar Products

Comparator sourcing for clinical trials has always been challenging, requiring a robust supply chain, advanced forecasting operations, and logistics expertise. In recent years, the advent and rapid growth of the biopharmaceutical market and the increasing market demand for biosimilars have intensified these challenges by an order of magnitude.

Biopharmaceuticals, or biologics, have a more complicated structural character than small molecules and are significantly more time-consuming, challenging, and expensive to produce. The complexity and high production costs translate into high market prices, supply limitations, and a desire on the part of manufacturers to protect their investment for as long as possible. These are all barriers to market access for developers of biosimilars who are racing to file their drug for regulatory approval as soon as possible after the reference drug’s patent expires, while also staying within their development budgets.

The manufacturers of the original biologics have no real interest in facilitating research and development for new entrant drugs and will not compromise on drug pricing for use in future competitors’ clinical trials. Therefore, during the period of patent protection, development companies have no alternative but to allocate more of their budget to comparator sourcing and pay the cost of sourcing the original drug.

The cost and access landscape changes when the original patent expires. Market competition through new biosimilars creates price erosion, and a variety of sourcing options become available. In particular, biosimilar manufacturers are often willing and eager to supply their newly marketed products for clinical trials because doing so can enhance their own market penetration and brand recognition. This can reduce comparator supply costs significantly. Importantly, it also establishes collaborative relationships that can be leveraged before the originator’s patent expires under a research exception to patent infringement called the Bolar exemption.

This whitepaper provides insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies. The key elements of the report include:

• The specificities and challenges of pharmaceutical patents
• The definition and patent implications of the Bolar exemption
• Regional differences in Bolar and Bolar-like provisions
• Strategies for leveraging these exemptions to accelerate market access for generics and biosimilars