Solumarv

Refused

This medicine has been refused authorisation

insulin human

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.

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.

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

AdoptedReference Number: EMA/765377/2015

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

AdoptedReference Number: EMA/596513/2015