Sanofi Wins FDA Approval For Biosimilar Of Lilly's Humalog

Sanofi (PA:SASY) (NYSE:SNY) received FDA approval for Admelog, its biosimilar version of Eli Lilly & Company’s (NYSE:LLY) blockbuster rapid-acting insulin, Humalog (insulin lispro). Admelog is technically a follow-on biologic version of Humalog, which recorded sales of $2.08 billion in 2017 so far.

Admelog is the first follow-on Humalog product to be approved by the FDA to help adult patients with type II diabetes and children (3 years and older) with type I diabetes manage their blood sugar levels at mealtime.

Admelog (100 Units/mL) will be available in the United States in vial and SoloStar pen. Please note that Admelog received marketing approval in the EU in July this year.

Sanofi’s shares have risen 8% so far this year, comparing unfavorably with a gain of 15.6% recorded by the industry.

Sanofi’s Diabetes franchise is under significant pressure with key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets and Japan. Moreover, a follow-on product to Lantus hit the market in the form of Lilly and Boehringer Ingelheim’s, Basaglar in mid-December 2016.

In 2017 so far, Lantus sales have declined 24.9% in the United States due to lower average net price and exclusion from the CVS Health Corporation (NYSE:CVS) and United Health formulary plans. U.S. diabetes sales have declined 20.2% so far in 2017.

In fact, U.S. diabetes franchise sales are expected to decline at an accelerated rate in the fourth quarter due to CVS/United Health formulary exclusion plans, continued lower average pricing and difficult comparisons with the last year.

Sanofi carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked large-cap pharma stock is H. Lundbeck A/S (OTC:HLUYY) carrying a Zacks Rank #2 (Buy).

Shares of Lundbeck have risen 19.4% so far this year while 2018 earnings estimates have gone up 3.2% in the past 60 days.

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