Goserelin Cell Pharm - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).

The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.

What is goserelin?

Goserelin is used to treat patients with advanced prostate cancer. It is a copy of the natural hormone (luteinizing hormone-releasing hormone) that regulates many processes in the body. In prostate cancer it works by depriving prostate cancer cells of the male hormone testosterone on which they depend to grow and spread.

Goserelin is marketed as a hybrid of Zoladex under the names Novimp, Goserelin Cell Pharma, Novosis Goserelin and associated names.

Why was goserelin reviewed?

Following an inspection, the German medicines regulatory agency found that the clinical studies performed as part of the marketing authorisation applications for some goserelin-containing medicines were not conducted in accordance with good clinical practice (GCP) and questioned whether their results could be relied on. The German medicines regulatory agency considered that a suspension of the marketing authorisation of the already authorised medicines was necessary as therapeutic equivalence with the reference medicinal product could not be guaranteed. On 16 March 2011, the German agency referred the matter to the CHMP so that the Committee could give its opinion on whether the marketing authorisations for Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names should be maintained, varied, suspended or withdrawn across the European Union (EU).

What are the conclusions of the CHMP?

Based on the evaluation of the studies that were submitted in support of the marketing authorisation application and the scientific discussion within the Committee, the CHMP concluded that therapeutic equivalence has not been demonstrated and as such the benefit risk balance for these hybrid products was considered negative. The marketing authorisation should therefore be suspended in all Member States until the companies provide new studies showing therapeutic equivalence and being GCP compliant.

The European Commission issued a decision on 16 September 2011.

Questions and answers on the review of Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant)

Adopted Reference Number: EMA/CHMP/477156/2011 Summary:

The European Medicines Agency has completed a review of the clinical studies that were submitted aspart of the marketing authorisation application of the hybrid (a type of generic) medicinal productsNovosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).

Key facts

About this medicine

• Approved name:
  Goserelin Cell Pharm
• International non-proprietary name (INN) or common name:
  goserelin
• Associated names:
  • Novosis Goserelin
  • Goserelin Cell Pharm
  • Novimp and associated names

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-36/1297
• Type:
  Article 36 referrals (prior to July 2012)

  This type of referral applied for a marketing authorisation that were granted via the mutual-recognition or decentralised procedure. It was triggered when a Member State considered that action (variation, suspension or withdrawal) was needed on the grounds of the need to protect public health. This referral has been replaced by Articles 107i and 31.

Key dates and outcomes

• CHMP opinion date:
  23/06/2011
• EC decision date:
  16/09/2011

All documents

Goserelin Cell Pharm - Article 36 referral - Assessment report

Goserelin Cell Pharm - Article 36 referral - Annex I

Goserelin Cell Pharm - Article 36 referral - Annex II

Goserelin Cell Pharm - Article 36 referral - Annex III

Questions and answers on the review of Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant)

Adopted Reference Number: EMA/CHMP/477156/2011 Summary:

The European Medicines Agency has completed a review of the clinical studies that were submitted aspart of the marketing authorisation application of the hybrid (a type of generic) medicinal productsNovosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.