Keith Bradbury wrote a good piece in the Biotech blog summarizing the expected near term future state of biosimilars. The recently enacted Patient Protection and Affordable Care Act (gotta love the names of these bills - that's marketing!) creates a pathway for biosimilars to be approved in the US - and can be viewed somewhat analogously to the Hatch-Waxman Act that created a path for generics.
Under the biosimilar Act, the reference product manufacturer will enjoy a 12-year period of data exclusivity for data used in the submission. The clock starts running at the date of FDA approval. Despite this concession to novel entity producers, a concession that was not received with open arms by generic producers, there are still a number of drugs/therapeutic categories that can be expected to see biosimilar competition between now and 2015. That's because the patents have expired on some of these already. Drugs or drug categories that are expected to be more competitive with regard to biosimilar introductions over the next 5 years include:
- Human growth hormone. Patents expired and among first biologics in market ever.
- Recombinant insulins. Again patents expired and should be relatively easy to manufacture.
- Epoetin alfa. May require some additiona safety data with regard to cardiovascular risk.
- Leukine. Could see competition by 2014.
- Neutropenia drugs. Teva has already introduced a competitor and patents expire in 2013.
- Interferon-alfa. Many patents expired. Long history on market with a variety of diseases.
- RA drugs. This group would expect to see its greatest competition starting in 2014.
Big Pharma companies like Merck, Eli Lilly and AstraZeneca have stated their intention to compete in some of these biosimilar therapeutic categories. I don't think this list is in any way exhaustive. My contention is that in the future state of pharma, the biggest competitors will have a mixed portfolio of novel small and large molecule entities as well as generics and biosimilars. There will be a lot of cross licensing and co-marketing partnerships as well in my view. Companies ought to get busy building their collaborative networks of partners and their portfolios.
With biosimilars expected to offer US consumers up to 30% in savings, CBO projects $25 B in savings from 2009-2018, over the reference drugs, there is NO WAY the tide will ever be turning back. Successful companies will need to build this part of the offer into their long-term strategy.
Posted by Bruce Lehr June 24th 2010.