Will Approval of Mvasi (bevacizumab-awwb) Result in Pricing Discounts Seen to Date for Biosimilars?

On September 14, 2017, the Food and Drug Administration approved the first biosimilar for Genentech’s Avastin® (bevacizumab), which is the first oncological biosimilar product on the U.S. market.Avastin is approved for eight oncological indications, two of which have an orphan drug exclusivity through 2021.The approval of Amgen’s Mvasi™ (bevacizumab-awwb) includes 6 indications (Table 1). The indications of fallopian tube and epithelial cancer have an orphan drug designation which is set to expire in November 2021.Of interest in this approval is that the approval of Mvasi did not automatically include all approved indications, as is seen with generics. This is not a complete surprise but reflects a significant consideration as health plans develop their strategy on biosimilar use.

Table 1 – Comparison of approved indications and approval dates for Avastin versus Mvasi

IndicationAvastin® (bevacizumab)Mvasi (bevacizumab-awwb)
Fallopian Tube Cancer11/14/2014
Epithelial Ovarian Cancer11/14/2014
Peritoneal Cancer11/14/20149/14/2017
Persistent, recurrent, or metastatic cervical cancer8/14/20149/14/2017
Metastatic Renal Cell Carcinoma7/31/20099/14/2017
Glioblastoma Multiforme (GBM)5/5/20099/14/2017
Non-Small Cell Lung Cancer (NSCLC)10/11/20069/14/2017
Metastatic Colorectal Cancer2/26/20049/14/2017

The approval of Mvasi generated discussion within RJ Health on what could be the potential price of Mvasi and whether our historical pricing data could be utilized to develop modeling to predict a potential price range?To answer this, we reviewed our historical pricing data to ascertain the discount rates for current biosimilars on the market, specifically, focusing on pricing for infliximab and filgrastim both having originator and biosimilars on the market. For infliximab, the initial biosimilar (Inflectra®) had a discount rate of 19 percent, compared with the second biosimilar to the market (Renflexis™) with a discount of 35 percent (Table 2). A similar comparison for filgrastim, which has a single biosimilar on the market, was determined to have a 15% discount (Table 3).

Table 2: Price comparison for Remicade and its available biosimilar products

DrugManufacturerApproval dateWACWAC DiscountAWPAWP Discount
Renflexis (infliximab-abda)Merck4/21/2017$753.39-35%$904.07-35%
Inflectra (infliximab-dyyb)Pfizer4/5/2016$946.28-19%$1,135.54-19%

Table 3: Price comparison for Neupogen and Zarxio

DrugManufacturerApproval dateWACWAC DiscountAWPAWP Discount
Zarxio (filgrastim-sndz)Sandoz3/6/2015$548.73-15%$658.48-15%

With the current precedence of applying a discount of 15 to 20 percent on a first to market biosimilar, we would anticipate Amgen to follow suit and price Mvasi within the same range of discounts resulting in a Wholesale Acquisition Cost (WAC) in the range of $151 to $161 per vial (Table 3).

Table 4: Price Prediction for Mvasi

DrugManufacturerApproval datePricing EstimateWACWAC DiscountAWPAWP Discount
Avastin (bevacizumab)Genentech$189.64$227.56
Mvasi (bevacizumab-awwb) Amgen9/14/2017Low $161.19-15%$193.43-15%
Mvasi (bevacizumab-awwb) Amgen9/14/2017High$151.71-20%$182.05-20%

We will be monitoring this launch closely to see how close our predictive model approximates the actual pricing. Of note, a secondary biosimilar is in development for Avastin by Pfizer, but to date has not been submitted to the FDA for review. Current estimates by GlobalData project a potential launch in 2019. Having a view into potential pricing prior to the launch of a drug can serve as an important source of data for the strategic development of the management of specific drug classes.