Solumarv

insulin human

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On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes.

The company that applied for authorisation is Marvel Lifesciences Ltd. It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

What is Solumarv?

Solumarv is a medicine that contains the active substance human insulin. It was to be available as a solution for injection.

Solumarv was developed as a biosimilar medicine. This means that it was intended to be similar to a biological medicine (the ‘reference medicine’) already authorised in the European Union (EU).

The reference medicine for Solumarv in this application was Humulin S.

What was Solumarv expected to be used for?

Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.

How is Solumarv expected to work?

Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively. Solumarv was intended as a replacement for the insulin made by the body.

What did the company present to support its application?

The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine. Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.

What were the CHMP’s main concerns that led to the refusal?

The CHMP’s main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail. As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S’s.

The CHMP concluded that Solumarv could not be approved as a biosimilar of Humulin S and recommended that it be refused marketing authorisation.

What consequences does this refusal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee’s opinion.

Name Language First published Last updated
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) BG = bălgarski 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) ES = español 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) CS = čeština 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) DA = dansk 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) DE = Deutsch 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) ET = eesti keel 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) EL = elliniká 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) EN = English 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) FR = français 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) IT = italiano 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) LV = latviešu valoda 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) LT = lietuvių kalba 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) HU = magyar 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) MT = Malti 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) NL = Nederlands 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) PL = polski 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) PT = português 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) RO = română 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) SK = slovenčina 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) SL = slovenščina 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) FI = suomi 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) SV = svenska 20/11/2015  
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) HR = Hrvatski 20/11/2015  

Application details

Product details

Product details for Solumarv
NameSolumarv
Active substance

insulin human

International non-proprietary name (INN) or common name

insulin human

Therapeutic area Diabetes Mellitus

Application details

Product details for Solumarv
Marketing-authorisation applicant

Marvel Lifesciences Ltd

Date of opinion19/11/2015
Date of refusal of marketing authorisation19/11/2015

Assessment History

Name Language First published Last updated
Solumarv : EPAR - Public assessment report HR = Hrvatski 16/02/2016