My last post on the issue of interchangeability and its impact on the future of U.S. biosimilars was well received. As a result, here are some additional thoughts to follow-up to the first blog, which can be viewed here in case you missed it.
Upon reflection and some engaging conversations around the three Sandoz products highlighted in the first post, I really need to talk about two other products to give you the full picture.
So what did I not mention?
Lantus is a massively well-selling long acting insulin product, and has a “follow on” biologic product called Basaglar, from Lilly and BI, already recently approved. Basaglar was approved through the new drug application (NDA) pathway, which necessitated the filing of Basaglar through the 505(b)(2) regulatory pathway and not the 351(k) Biosimilar pathway. In part, this was needed as there is no insulin glargine products currently licensed under the Public Health Service Act. Thus, without a “reference product” for a proposed Biosimilar product, it needed to use a different pathway to come to market. This should drive the need for states to deviate from existing legislation to make auto substitution a reality for Basaglar. Expect an increased focused on MCO contracting from the makers of this and other “follow on” insulin glargine products; and the use hard hitting sales and marketing to get share.
One to watch is Pfizer and Celltrion's Biosimilar version of Remicade, currently in motion for an FDA approval. The FDA’s choice of whether or not to anoint them with an interchangeable status will greatly impact the future of managed care access and patient access in the very crowded and highly competitive TNFa market. Considering the EU clinical experience for the product and a review of some comments by the FDA about the Remicade application, it will be interesting to watch how the approval materializes.
The Biosimilar Show is one of the most entertaining and complex shows on the pharma channel today. So, what to watch?
- FDA Terminology to watch: Interchangeability with a Reference Product for every Biosimilar and Follow On Biologic approval, every time.
- Legislation to watch: How many more states (e.g. New York, Pennsylvania, and Florida have pending legislation) join the other 16 states that allow for auto substitution of Biosimilars. Also, will the Federal government come in with a recommendation (like the CDC with pain killers) or a law?
- Product to watch: Biosimilar Remicade and how the FDA decision plays out will help to set the precedent for other products yet to come.
This is a show that has high ratings with pharma, health plans and PBMs, alike. Healthcare providers are tuning in as well; they just don’t have a lot of time.
Check back later for more trends on trending therapeutic areas and topics in healthcare.
Jack Bilson, III is a Father, Assistant Scoutmaster, Pharmaceutical Consultant and Vice President at MMIT (MMIT brings transparency and guidance to pharmacy and medical benefit information).
He tweets about healthcare stuff and occasionally StarWars @jackbilson3
His views expressed here are his own.