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EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca Posted 05/10/2018

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

US-based drugmaker Mylan and partner Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 20 September 2018 that they had received European Commission (EC) approval for their adalimumab biosimilar Hulio (FKB327).

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 27 July 2018. The EC’s approval is based on the CHMP recommendation, which concluded that the development programme, including analytical, functional, clinical and immunogenicity data, demonstrated biosimilarity with the reference product, Humira [1].

The EC approval of Hulio applies to all 28 European Union (EU) member countries and European Economic Area (EEA) Member States of Norway, Iceland and Liechtenstein. Mylan plans to launch Hulio across various markets in Europe on or after 16 October 2018. Mylan and Fujifilm Kyowa Kirin Biologics agreed to partner on the adalimumab biosimilar FKB327 in April 2018 [2]. Fujifilm Kyowa Kirin Biologics has a non-exclusive royalty bearing license with AbbVie (Mylan has a sublicense) for the use and sale of Hulio in European countries.

Hulio marks the second European approval for a Mylan biosimilar. The company gained EC approval for its insulin biosimilar Semglee in March 2018 [3]. Mylan also received a positive recommendation for its pegfilgrastim biosimilar Fulphila in September 2018 [4]. Mylan President Rajiv Malik said that Hulio ‘is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars’, implying that another product is on the way.

Then on 25 September 2018, US-based biosimilars specialist Coherus BioSciences (Coherus) announced that they had received EC approval for their pegfilgrastim biosimilar Udenyca (CHS‑1701). The approval by the EC follows the positive recommendation by the EMA’s CHMP on 26 July 2018.

Coherus submitted also an application for approval for Udenyca to the US Food and Drug Administration (FDA) in October 2016 [5] but received a rejection from the agency in June 2017 [6]. However, the company now says that Udenyca is currently under evaluation by FDA with an action date of 3 November 2018.

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References
1.  GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-pegfilgrastim-biosimilars
2.  GaBI Online - Generics and Biosimilars Initiative. Mylan and Fujifilm Kyowa Kirin Biologics partner on adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Fujifilm-Kyowa-Kirin-Biologics-partner-on-adalimumab-biosimilar
3.  GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilar Semglee gains EC and Australian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval
4.  GaBI Online - Generics and Biosimilars Initiative. EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-pegfilgrastim-biosimilars-Fulphila-Pelmeg-and-Ziextenzo
5.  GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
6.  GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgratim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus

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Source: Coherus, EMA, Fujifilm Kyowa Kirin Biologics, Mylan

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