With biologics and other specialty drugs driving increased spending on prescription therapies, biosimilars present an opportunity for a breakthrough in reducing the cost of care. This makes it all the more important for manufacturers to be prepared with commercialization strategies that ensure access and uptake of biosimilars in the clinical setting. What does the biosimilar market look like now, where is it headed, and how can manufacturers ensure their therapies thrive as it becomes increasingly competitive?
Biosimilars
Shaping a Moving Market
Market snapshot
approvals to date
First FDA approval in
products have launched to date
(available in full-line and specialty distribution channels)
Boom in 2018 and 2019 with
FDA approvals
23
2013
14
Only 9
Biosimilar market share in the United States is minimal to date. Limited distribution models, litigation and the legislative landscape have stunted market growth.
Source: IQVIA. National Sales Perspective. January 2019
Filgrastim
Infliximab
pegfilgrastim
$611.3M
$5.5B
$4.3B
GRANIX NEUPOGEN ZARXIO NIVESTYM
INFLECTRA REMICADE RENFLEXIS
FULPHILA NEULASTA NEULASTA ONPRO
32%
48%
20%
96%
61%
38%
0%
1%
3%
BUT spending and share are rising ...
Source: IQVIA. Medicine Use and Spending in the U.S. May 2019. Available online at https://www.iqvia.com/institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023.
2017
2018
The landscape is changing
Many brands will lose exclusivity over the next 5 years That’s expected to generate savings of $78 billion for the same period Part of those savings could be reached through increased biosimilar adoption
Contributing factors to increased market share
What it means for manufacturers: Competition. The number of products available to patients will potentially double. Just look at the potential market size–and potential competitors–for current innovator products:
NEUPOGEN
REMICADE
EPOGEN
NEULASTA
AVASTIN
HERCEPTIN
RITUXAN
2
1
3
6
Brand name innovator Number of competitors
$800M
$5.4B
$2.4B
$3.0B
$2.6B
$3.9B
8 new biosimilars are expected to launch in 2019/2020.
Many of the new biosimilars will be available to all channels, including full-line wholesale, while their innovators are only available via specialty distribution.
What it means for manufacturers: For these new biosimilars, expanded access for some sites of care means a potentially untapped market in the hospital and health systems space. For innovators, the need to reassess channel strategy in order to access these markets.
Good news for biosimilars: One national payer is requiring patients to “fail” on a biosimilar before covering an originator product. Bad news for biosimilars: Another national payer has advantaged an originator over a biosimilar on its formulary.
Payers and PBMs continue to evolve their coverage strategies.
The FDA has issued its long-awaited guidance on interchangeability.
What it may mean for manufacturers: In the future, Biosimilars may be substituted for originator products without prescriber signoff. What it may mean for the biosimilar market: Interchangeability will make it easier for manufacturers to develop biosimilars creating a more competitive market. Increased competition may lead to increased patient access to these more affordable biosimilar products.
How to ensure market success
Understand and equip providers to overcome adoption barriers
Assess your channel strategy
Stay abreast of legislative developments and evolving payer strategies
Does your provider population understand the benefits of your product? Do they need advanced education?
Is your product available wherever patients are presenting for treatment?
What reimbursement and affordability challenges are providers and patients facing? How can you support them with field reimbursement support or patient services?
Learn more about how AmerisourceBergen is poised to help support biosimilar adoption and success at AmerisourceBergen.com
