Apotex petitions FDA over Neulasta biosimilars Posted 19/05/2017

Apotex, and its specialist biosimilars unit Apobiologix, submitted a Citizen Petition on 21 April 2017 to the US Food and Drug Administration (FDA). The petition requests that the agency requires all biosimilar applicants referencing Neulasta (pegfilgrastim) to ‘conduct their comparative clinical efficacy studies (including pharmacokinetics (PK) and pharmacodynamics (PD) studies and immunogenicity studies) in at least one intended patient population’.

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Apotex says that, ‘for healthy subjects with normal absolute neutrophil counts (ANC), comparative clinical studies administering pegfilgrastim alone would not demonstrate ‘no clinically meaningful differences’ between a proposed biosimilar and Neulasta for one of the indications for Neulasta’.

Apotex submitted its own pegfilgrastim biosimilar application for FDA review in December 2014 [1]. The application included comparative efficacy data from patients with breast cancer.

Apotex has also requested that FDA requires pegfilgrastim biosimilar applicants to ‘conduct immunogenicity studies over at least four and preferably six cycles’. This, the company says, ‘reflects a median or typical initial course of most chemotherapies, when comparing Neulasta and the proposed biosimilar product’.

The company points out that in its guidance on Clinical Pharmacology Data for biosimilars [2], FDA requires applicants to use a ‘population that is representative of the patient population to which the drug would be targeted’ … ‘unless a study in a different population would be more sensitive to detect potential differences between the proposed biosimilar product and the reference product’.

The Citizen Petition cites an application made by Coherus Biosciences in August 2016 for a pegfilgrastim biosimilar, which is based on data from a clinical trial involving only healthy patients. In contrast, Apotex conducted its phase III studies in breast cancer patients ‘actively undergoing multiple cycles of chemotherapy’. It adds that its ‘trials were conducted through six cycles of chemotherapy, mimicking typical chemotherapy exposure to pegfilgrastim for breast cancer patients’.

There are currently no pegfilgrastim biosimilars approved in either the US or the EU. The European Medicines Agency is currently reviewing two applications of pegfilgrastim biosimilar [3]. As well as the two applications of pegfilgrastim biosimilar from Apotex and Coherus, FDA is reviewing an application from Sandoz [4].

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1. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
2. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – April 2017 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-April-2017
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar

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Source: Apobiologix,Citizen Petition

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