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The Pending U.S. Biosimilar Wave and Interchangeability

Posted by Jack Bilson on Mar 21, 2016

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Everywhere you turn, people talk about how payers will reap billions of savings from Biosimilars. Those that work with me certainly hear me yelping about the upcoming impact of Biosimilars, nearly every day. However, despite some important follow-on Biologic and Biosimilar approvals already, the savings do not meet everyone’s expectations. One of the primary reasons for this is the much ignored issue of interchangeability, which is relevant at the federal level but largely a state issue. Additionally, many underestimated the possible impact of the original patent holders. A review of Sandoz’s position in the market and their three approved products helps us to understand what is happening in today’s landscape.

  • Omnitrope (somatropin) is a human growth hormone treatment, based on Pfizer’s product. First introduced in 2004, it was the first biopharma product ever approved by health authorities based on a Biosimilar pathway. It needs to be written as Omnitrope to get dispensed. I sometimes think only I and the new COO of MannKind remember this product even exists.
  • Zarxio (filgrastim-sndz), a supportive cancer product, based on Amgen’s Neupogen. It’s technically the first Biosimilar product approved in the United States in March of 2015. While approved as a Biosimilar, Sandoz did not seek approval as interchangeable.
  • Glatopa (glatiramer acetate injection) 20mg a core product used in the treatment of MS, based on Teva’s product. First approved in June of 2015, it’s considered a substitutable generic version of Copaxone 20mg.

Some financial analysts feel that these drugs should generate more sales, but there is a good explanation behind this.

  • HgH is a strange marketplace with fierce competition. Many other manufactures invest heavily in great support programs and product pen innovation. Sandoz improved its pen design 4 years after its initial launch but some feel it was too late. The product needed to be written and marketed like any other HgH product, but Sandoz really never took on others in the market.
  • Neupogen is a well understood product, and Sandoz had a EU approval and years of clinical experience with their version of Neupogen. Here, I disagree with analysts’ disappointment. In the first four months Sandoz grabbed nearly 25% of the market. Given that the product is not interchangeable, that demonstrates some smart contracting with payers/PBMs with solid sales and marketing. 
  • Copaxone is an amazing product, both for MS patients and for the bottom line of Teva. Teva developed a newer higher dose version of Copaxone, which requires fewer injections and therefore moved over 60% of all of its patients over prior to the launch of Glatopa. Teva had years to switch people, and it might be the most successful Rx switch ever. It protected the profit of Teva, and added convenience to the daily lives of many MS patients. As such Glatopa splits the market on a small amount of script volume; however, it has a leg up in many states.

Why is it important to look at Biosimilars at the state level? Kentucky just joined 15 other states with Mandatory Prescription Drug Substitution Laws that largely allow for interchangeable Biologic products to be substituted upon the prescribing HCP’s notice of the switch. So, while the federal government determines if a product is interchangeable to its reference product at approval, it’s left to the states to determine how (or if) these products get substituted. Pharmacies are managed by the states and not the federal government, so this makes this makes for a patchwork of legislation across the country. Of the three products mentioned in this post, only Glatopa benefits here as interchangeable, and Teva has pulled out all of the stops to make sure its newest version (the non-generic one) gets utilized. Effective sales and marketing are still critical with Biosimilars.

The lesson here is that with or without interchangeability, sales and marketing and an appropriate managed care access strategy will always be needed. However, the support of interchangeability at the state level helps the adoption and use of a new Biosimilar.

Check back later this week to view part 2 as well as more trends on trending therapeutic areas and topics in healthcare.

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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.

Topics: Specialty, Industry Trends, Market Access