Overview

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.

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

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.

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.

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.

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

Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human)

български (BG) (119.03 KB - PDF)
español (ES) (111.57 KB - PDF)
čeština (CS) (113.31 KB - PDF)
dansk (DA) (112.14 KB - PDF)
Deutsch (DE) (114.32 KB - PDF)
eesti keel (ET) (110.18 KB - PDF)
ελληνικά (EL) (120.77 KB - PDF)
français (FR) (112.63 KB - PDF)
hrvatski (HR) (112.21 KB - PDF)
italiano (IT) (110.94 KB - PDF)
latviešu valoda (LV) (124.86 KB - PDF)
lietuvių kalba (LT) (113.11 KB - PDF)
magyar (HU) (112.56 KB - PDF)
Malti (MT) (115.38 KB - PDF)
Nederlands (NL) (112.04 KB - PDF)
polski (PL) (113.8 KB - PDF)
português (PT) (112.58 KB - PDF)
română (RO) (111.95 KB - PDF)
slovenčina (SK) (113.23 KB - PDF)
slovenščina (SL) (112.21 KB - PDF)
Suomi (FI) (110.31 KB - PDF)
svenska (SV) (111.2 KB - PDF)

Product details

Name of medicine
Solumarv
Active substance
Insulin human
International non-proprietary name (INN) or common name
insulin human
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AB01

Application details

EMA product number
EMEA/H/C/003858

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation applicant
Marvel Lifesciences Ltd
Opinion adopted
19/11/2015
Refusal of marketing authorisation
11/02/2016

Assessment history

Solumarv : EPAR - Public assessment report

This page was last updated on

How useful do you find this page?