Biosimilars Lead to Lower Q2 Sales for Sanofi, Muted Success for Pfizer

Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.

US sales of Sanofi’s insulin glargine products (Lantus and Toujeo) declined by 23.9%, a dip that Sanofi primarily attributes to the exclusion of Lantus from commercial formularies (CVS and United Health). In addition, European sales of insulin glargine were down 2% due to competition from approved European biosimilar products. The company also lost sales of enoxaparin (Lovenox); availability of a European biosimilar to the low-molecular-weight heparin resulted in a 2.4% decrease in sales of Sanofi’s originator drug—an upset large enough, the company reported, to offset strong sales of reference enoxaparin in emerging markets. (Follow-on insulin and heparin products, while regulated as biosimilars by the European Medicines Agency, are not treated as biosimilar products in the United States. The FDA regulates innovator treatments in these categories as drugs rather than as biologics, and treatments modeled on these innovators as follow-ons).

Sanofi does not expect a turnaround in its fortunes any time soon, according to CEO Oliver Brandicourt, who said that the company expects an accelerated decline in sales in the second half of 2017.

While reference product developers may feel pressure from biosimilar products abroad, at least 1 biosimilar has had a somewhat disappointing second quarter in the United States. Pfizer’s Inflectra, a biosimilar infliximab product, earned only $94 million in second-quarter sales, according to Pfizer’s newly released numbers. Inflectra only gained 2% market share, the company said, because insurers have largely continued to prefer the reference Remicade because of additional discounts offered by Janssen Biotech.

Tides could be turning for reference products, however—Express Scripts, a pharmacy benefit manager, introduced several exclusions in its 2018 National Preferred Formulary, including reference filgrastim (Neupogen), which was replaced by filgrastim-sndz (Zarxio) and TBO-filgrastim (Granix).

While the formulary did not exclude other innovator products in favor of their biosimilars or follow-ons, Express Scripts notes that it is continuing to adjust its formulary according to market dynamics and the launches of new products, and says that it will not issue a final list of excluded medications and preferred alternatives until September.

Notably, Merck and Samsung Bioepis have priced their newly launched infliximab-abda (Renflexis) at a 35% discount to the list price of the reference Remicade (while Pfizer launched its Inflectra at a more conservative 15% discount). It is not yet clear whether the Merck—Samsung partnership will see its biosimilar achieve rapid preferred-product status on such formularies, but its initial price gambit could persuade insurers to prefer the biosimilar to the reference and to drive the rate of sales erosion that Sanofi feels in the European marketplace.