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