Αρχική World News EMA Recommends Granting a Marketing Authorisation for Biosimilar Bevacizumab

EMA Recommends Granting a Marketing Authorisation for Biosimilar Bevacizumab

On 25 June 2020, 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 the medicinal product Aybintio (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

The applicant for this medicinal product is Samsung Bioepis NL B.V.

Aybintio will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Aybintio is bevacizumab, a monoclonal antibody (ATC code: L01XC07) which 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 regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.

Aybintio is a biosimilar medicinal product. It is highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005. Data show that Aybintio has comparable quality, safety and efficacy to Avastin.

The full list of indications is:

  • Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
  • Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
  • Aybintio in combination with capecitabine is indicated 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 Aybintio in combination with capecitabine.
  • Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
  • Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor (EGFR) activating mutations.
  • Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic RCC.
  • Aybintio, in combination with carboplatin and paclitaxel is indicated 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.
  • Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated 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.
  • Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated 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.
  • Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

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

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

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

Source

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