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EMA Grants a Marketing Authorisation for Two Biosimilar Medicines, Bevacizumab

They received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian cancer, and carcinoma of the cervix
15 Feb 2021
Anticancer agents & Biologic therapy

On 28 January 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for two biosimilar medicinal products, bevacizumab (Alymsys) and bevacizumab (Oyavas), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

The applicant for Alymsys is Mabxience Research SL. The applicant for Oyavas is STADA Arzneimittel AG.

Alymsys will be available as 25 mg/ml concentrate for solution for infusion. Oyavas will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Alymsys and Oyavas is bevacizumab, a monoclonal antibody (ATC code: L01XC07). It binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby inhibiting the binding of VEGF to its receptors on the surface of endothelial cells. Neutralising the biological activity of VEGF reduces vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.

Alymsys and Oyavas are biosimilar medicinal products. They are highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005. Data show that Alymsys and Oyavas have comparable quality, safety and efficacy to Avastin (bevacizumab).

The full indications for Alymsys and Oyavas are:

  • in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum.
  • in combination with paclitaxel for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, it should be refered to section 5.1.
  • in combination with capecitabine for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys and Oyavas in combination with capecitabine. For further information as to HER2 status, it should be referred to section 5.1.
  • in addition to platinum-based chemotherapy for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.
  • in combination with erlotinib, for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor (EGFR) activating mutations.
  • in combination with interferon alfa-2a for first-line treatment of adult patients with advanced and/or metastatic RCC.
  • in combination with carboplatin and paclitaxel for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
  • in combination with topotecan, or pegylated liposomal doxorubicin for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
  • in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

It is proposed that Alymsys and Oyavas be prescribed by physicians experienced in the use of antineoplastic medicinal products.

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

Summaries of positive opinions are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.

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