Sanofi’s Insulin Aspart Biosimilar Receives CHMP’s Positive Recommendation for Approval in the EU

 Sanofi’s Insulin Aspart Biosimilar Receives CHMP’s Positive Recommendation for Approval in the EU

Sanofi Reports Results of Olipudase alfa in Two Studies for Acid Sphingomyelinase Deficiency in Adults and Pediatric Patients

Shots:

  • The CHMP’s positive recommendation is based on the clinical development program that comprises P-I PK/PD study that evaluates product’s similarity in exposure and activity1 and P-III Gemelli 12 study to evaluate the safety & efficacy
  • The clinical program involves 600+ patients with T1D or T2D. Both the studies compared the biosimilar to insulin aspart 100 Units/mL as currently approved for use by adults with T1D/ T2D in the US and EU
  • The CHMP’s positive opinion marks the first regulatory milestone in the EU for any biosimilar insulin aspart product. Additionally, Sanofi has two rapid-acting insulin analogs approved in the EU

Click here to read full press release/ article | Ref: EMA | Image: Behnace

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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