Brief

Sanofi continues biologics push, building on recent approvals

Dive Brief:

  • French pharma Sanofi plans to invest €600 million ($673 million) annually in biologics production and manufacturing for the next two to three years, Reuters reports and a company spokesperson confirmed to BioPharma Dive. 
  • Sanofi recently won approval for two biologic drugs, Dupixent (dupilumab) and Kevzara (sarilumab), which the drugmaker hopes will form the foundation of an industry-leading immunology portfolio. Biologics, produced from living cells, are more complicated to synthesize and produce than small-molecule medicines. 
  • The planned commitment this year includes a joint venture Sanofi announced with Swiss pharmaceutical supplier and manufacturer Lonza in February. The two will build a large-scale monoclonal antibody production center in Visp, Switzerland with an initial €270 million investment, split equally. 

Dive Insight:

Sanofi's stepped-up focus on biologics development fits in with an industry-wide turn towards the large molecule drugs. Drugmakers have upped investment into biologics manufacturing networks, breaking ground on new plants or retooling existing production chains to push new, high-value medicines to market. 

That investment has been reflected in the number of novel biologics approved by the Food and Drug Administration: nearly 28% of new molecular entities approved between 2014 and 2016 were biologics. Spending has risen in lockstep, with double digit increases in net spending each year for the last five years, according to data from QuintilesIMS. Last year, total net spending on biologics totaled $106 billion, up from $65 billion in 2011. 

Drugs like the wave of anti-PD1 cancer immunotherapies, Roche's multiple sclerosis med Ocrevus (orcrelizumab) and Sanofi's two immunology medicines are all pegged for blockbuster sales in the coming years. 

A Sanofi spokesperson said the company invests roughly €1 billion per year in its global industrial affairs network, with a roughly 60%/40% split between funds directed at biologics manufacturing and small molecules. 

Biologics account for a similar 60% share of Sanofi's pipeline, said Phillipe Luscan, head of global industry affairs at Sanofi, in the February announcement with Lonza. While Dupixent and Kevzara were the two top biologics candidates, Sanofi is developing its own PD-1 inhibitor as well as several other monoclonal antibodies for cancer. 

Sanofi has seen setbacks, however. The Food and Drug Administration rejected Sanofi's first application for approval of Kevzara due to manufacturing-related deficiencies at the company's fill/finish facility in Le Trait, France. The problems delayed the drug's launch by nearly seven months, potentially costly given the competitive rheumatoid arthritis market.

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Filed Under: Manufacturing
Top image credit: Sanofi/Flickr