EMA approval for adalimumab and trastuzumab biosimilars

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EMA approval for adalimumab and trastuzumab biosimilars

Biosimilares/Novedades | Posted 29/09/2017 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Cyltezo and the trastuzumab biosimilar Ontruzant.

Cyltezo is produced by Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim). The company had its candidate adalimumab biosimilar (BI 695501) accepted for regulatory review by both EMA and the US Food and Drug Administration (FDA) in January 2017 [1], FDA approved Cyltezo in August 2017 [2].

The CHMP has recommended that Cyltezo be approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.

Three adalimumab biosimilars have already been approved for use in the European Union (EU). Amgen’s Amgevita and Solymbic received European Commission (EC) approval in March 2017 and Imraldi, produced by Samsung Bioepis, received approval in August 2017 [3].

Ontruzant is produced by South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis. The candidate adalimumab biosimilar (SB5) was accepted for review by EMA in July 2016 [4].

The CHMP has recommended that Ontruzant be approved for the treatment of early and metastatic breast cancer and metastatic gastric cancer. Ontruzant is the first trastuzumab biosimilar recommended for approval by the CHMP.

If marketing authorization is granted by the EC, Ontruzant will be commercialized in the EU by Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada.

The positive opinions will now be referred to the EC, which grants marketing authorizations for medicines in the EU.

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References
1.GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA
2.    GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo
3.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4.    GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis adalimumab biosimilar submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-adalimumab-biosimilar-submitted-to-EMA

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Source: Boehringer Ingelheim, EMA, Samsung Bioepis