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Date: 2018-09-20

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Fulphila®

Compound: pegfilgrastim - biosimilar version of Neulasta®

Therapeutic area: Cancer - Oncology

Action mechanism:

  • protein/biosimilar. Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF). Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar pegfilgrastim in the U.S. , Canada , Japan , Australia , New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Company: Mylan (USA - PA) Biocon (India)

Disease:

  • reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Latest news:

  • • On September 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the biosimilar medicinal product Fulphila®, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
  • Fulphila® will be available as a 6-mg solution for injection. It is highly similar to the reference product Neulasta® (pegfilgrastim), which was authorised in the EU on 22 August 2002. Data submitted as part of the Marketing Authorization Application included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to Neulasta®. The Phase I program in healthy volunteers and Phase III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta®.
  • • On June 4, 2018, the FDA approved Fulphila® (pegfilgrastim-jmdb) as the first biosimilar to Neulasta® to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
  • The FDA’s approval of Fulphila® is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Fulphila® is biosimilar to Neulasta®. Fulphila® has been approved as a biosimilar, not as an interchangeable product.
  • The most common side effects of Fulphila® are bone pain and pain in extremities. Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products should not take Fulphila.
  • Serious side effects from treatment with Fulphila® include rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, acute inflammation of the kidney (glomerulonephritis), an abnormally high level of white blood cells (leukocytosis), capillary leak syndrome and the potential for tumor growth. Fatal sickle cell crises have occurred.
  • • On August 3, 2017, Mylan officially notified the Committee for Medicinal Products for Human Use
  • (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila®, for reducing neutropenia in patients taking cancer treatments. The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. The CHMP was assessing the company’s responses to the questions at the time of the withdrawal. Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Fulphila® could not have been approved to reduce neutropenia in patients taking cancer treatments. One of the CHMP’s main concerns was the lack of a certificate of Good Manufacturing Practice (GMP) for the manufacturing site of the product. Other concerns related to the description of the manufacturing process, the control of impurities in the active substance and the sterilisation of the final product.
  • In its letter notifying the Agency of the withdrawal of the application, Mylan stated that it was withdrawing the application because a GMP certificate for the manufacturing site of Fulphila® could not be obtained in the time available.
  • • On July 21, 2016, Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted for review, Mylan's Marketing Authorization Application (MAA) for their proposed biosimilar pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Mylan and Biocon , who have co-developed the proposed biosimilar, received EMA's acceptance of the submission for review. In addition to analytical, functional and pre-clinical data, the application includes clinical data from pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016. The results from the studies are expected to be presented at the prestigious European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in Oct. 2016 .

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE: 2017-08-03

US authorization: 2018-06-04

UE authorization:

Favourable opinion UE: 2018-09-20

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes