EMA Recommends Granting a Marketing Authorisation for Pemetrexed Lilly and Pemetrexed Sandoz

Two generics of Alimta, which has been authorised in the EU since 2004

On 23 July 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal products Pemetrexed Lilly and Pemetrexed Sandoz, intended for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

The applicants for these medicinal products are Eli Lilly Netherlands and Sandoz GmbH.

Pemetrexed Lilly will be available as a powder (100 mg and 500 mg) for concentrate for solution for infusion.

Pemetrexed Sandoz will be available as a powder (100 mg, 500 mg and 1,000 mg) for concentrate for solution for infusion.

The active substance of Pemetrexed Lilly and Pemetrexed Sandoz, pemetrexed, is a multi-targeted anti-cancer antifolate agent (ATC code: L01BA04) that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.

Pemetrexed Lilly and Pemetrexed Sandoz are generic of Alimta, which has been authorised in the EU since 20 September 2004.

Studies have demonstrated the satisfactory quality of Pemetrexed Lilly and Pemetrexed Sandoz. Since Pemetrexed Lilly and Pemetrexed Sandoz are administered intravenously and are 100% bioavailable, bioequivalence studies versus the reference product Alimta were not required.
The full indication is:

Malignant pleural mesothelioma

  • In combination with cisplatin for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

  • In combination with cisplatin for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
  • As monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
  • As monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

It is proposed that Pemetrexed Lilly and Pemetrexed Sandoz be subject to prescription and administered under the supervision of physicians experienced in the use of anti-cancer chemotherapy.

Detailed recommendations for the use of these products will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisations have been granted by the European Commission.