Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Problem for biosimilars that won't affect Rolontis. NEJM article on the problems w biosimilars competing with reference product (i.e. Neulasta). Biosimilars have to jump through extra hoops to deem them interchangeable with reference product. Rolontis will have jumped through that extra hoop via the more involved clinical studies. The biosimilars to Neulasta (Note- there are still none out there) are, well, similar to Neulasta (G-CSF + PEG) whereas Rolontis has the same active moiety but with a proprietary platform technology called LAPSCOVERY. From the get go Rolontis had to do trials that prove it could be used instead of Neulasta i.e interchangeable whereas most biosimilars do not go through that extra step. As a result if a drug is not interchangeable doctors are much more hesitant to prescribe it whereas Rolontis won't have that problem.

Another regulatory issue involves the designation of interchangeability between a biosimilar and its reference drug. This designation makes it possible for a pharmacist to substitute the biosimilar product for the reference product without involving the prescribing physician. Interchangeability can promote strong price competition, as evidenced by competition between brand-name and generic small-molecule products. The FDA issued draft guidance in January 2017 that created confusion in the industry. Designation as a biosimilar requires demonstrating no clinical differences in outcome, but to identify a biosimilar product as interchangeable with its reference product, the FDA requires that equivalent clinical results occur within the same patient if the biosimilar replaces the reference product.

The FDA has not been clear about whether this requirement involves meeting an additional standard or producing more data. Conducting extra clinical studies is a very expensive activity, so clarity on this point is important. The FDA has concerns about immune system responses to substitution of biosimilars for reference products.
http://www.nejm.org/doi/full/10.1056/NEJMp1714908?query=TOC

I can see now why JT appears confident when talking about the market potential of Rolontis; it's interchangeable but has it's own J code. I think I need to be more optimistic about the market potential of Rolontis now that I see how it can compete. JT, you really should spell this out in your CCs, I think it would do wonders for the stock price. I can't believe I'm starting to get excited about Rolontis now after being pessimistic for the most part.