The Biologics Price Competition and Innovation Act passed this year gives biologic drugs a new pathway to market - if it can be shown to be biosimilar to a marketed (reference) drug. Previously this could only be done through a complete clinical trial program. The idea is to introduce more competition for these bio drugs similar to what has been done with Waxman-Hatch for the small molecule generic market.
A Fierce Biotech story this week explains that in order to really play in the biosimilar market in the next 5 years - a company will reqire heavy investment and infrastructure. This may seem counterintuitve as biosimilars are projected to eventually represent a cheaper (estimated at 30%) source of biologic drugs - at least that is the plan.
However, one will need to take proof of concept data with a biosimilar and ramp that up through expensive stages of clinical development - stages not suited to skills or pocket books of cash strapped small and medium biotechs. It also means having to run fairly expensive comparison studies to marketed therapeutics. The drugs of course will not be nmarketed prior to patent expiration on the reference product.
Experts estimate that it will take up to 8 years and $100M to $150 M dollars to get biosimilars to the point of being marketed. You also have the 12-year data exclusivity period for the reference products - a period keeps competitive drugs from being approved through a biosimilar pathway. This period starts when the reference product is first approved - and no biosimilar application filing can take place with the FDA until 4 years after approval. By contrast, NCEs now get about 5 years of regulatory exclusivity.
Given the costs and the still substantial regulatory requirements for biosimilars, it remains likely that only a hnadful of big pharma players will be able to exploit this pathway in the next 5 years.
To learn more about this topic, the PatentDoc blog provides a link to an SMi Conference entitled, "Biosimilars & Biobetters: Aligning Business & Science for Success". The conference is slated for London from September 22nd-23rd. Topics will cover changes in regulation and legislation in both the US and EU framework. More details on the program and pre-conference workshop can be found on the SMi site.
Posted by Bruce Lehr July 3rd 2010.