Positively Europe: Thumbs up for Amgen, Sandoz biosimilars

By Dan Stanton

- Last updated on GMT

The EMA has recommended the approvals of a third Herceptin (trastuzumab) biosimilar made by Amgen and Sandoz’s version of Remicade (infliximab).

Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the marketing authorisation of ABP 980, a version of Herceptin (trastuzumab) developed by Amgen and Allergan.

“The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar portfolio, as it’s our second oncology biosimilar to reach this important milestone, and further underscores our commitment to providing the oncology community access to high-quality cancer therapies,”​ said Amgen’s executive VP of R&D Sean Harper.

In January​, Mvasi, a biosimilar version of Roche’s (Avastin) bevacizumab, became the first of four cancer biosimilar products developed in the partnership to be approved in Europe.

If the European Commission (EC) approves ABP 980, it will become the third biosimilar version of Roche’s bestselling monoclonal antibody available in Europe after MSD (known in North America as Merck & Co.) launched Ontruzant earlier this month​, and Celltrion received approval​ for Herzuma.

Sandoz infliximab

Meanwhile, the CHMP also recommended the approval of another version of J&J’s Remicade (infliximab).

The molecule will be marketed by Novartis subsidiary Sandoz, which picked up the molecule in 2016​ after Pfizer was forced by the EC to divest the programme following its acquisition of Hospira.

“Sandoz is proud to be at the forefront of diversifying the biologics treatment landscape by bringing biosimilar medicines to market for patients living with devastating autoimmune diseases,” ​said Sandoz CEO Richard Francis.

If successful, it will become the third Sandoz monoclonal antibody biosimilar to be approved in the past 12 months. Its versions of Enbrel (etanercept) and Mabthera (rituximab) – Erelzi and Rixathon, respectively – were both approved in June last year.

Related topics Markets & Regulations Biosimilars

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