Last week, the European Medicines Agency (EMA) adopted a positive opinion for Amgen and Allergan’s ABP 215, to be known as Mvasi (bevacizumab). It is the first version of Roche’s bestselling cancer mAb Avastin to be recommended for approval in Europe, and will now be reviewed by the European Commission (EC).
But last week’s Committee for Medicinal Products for Human Use (CHMP) meeting also noted the marketing authorisation for a duplicate Amgen/Allergan bevacizumab – Kyomarc – has been withdrawn.
“Amgen submitted duplicate MAAs for ABP 215 (Mvasi and Kyomarc. Amgen decided on this strategy as we took into consideration a multitude of commercial options that may be present to us at time of launch,” Amgen spokesperson Kelley Davenport told Biopharma-Reporter.
“The withdrawal of the duplicate MAA for Kyomarc is due to marketing reasons,” she continued, adding the CHMP had no major concerns “and was of the provisional opinion that Kyomarc could have been approved for the treatment of the cancers.”
In September, Mvasi was approved by the US Food and Drug Administration (FDA).
Duplicate biosimilar MAAs
According to Article 82(1) of Regulation (EC) No 726/2004, the EC “shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.”
In March, Amgen received duplicate marketing authorisations for Amgevita and Solymbic – both biosimilar versions of AbbVie’s Humira (adalimumab).
Amgen did not reveal specific details for its biosimilar commercial strategy.
Another firm which has received duplicate biosimilar MAAs is Korean drugmaker Celltrion, with Inflectra and Remsima – its Remicade (infliximab) biosimilars – available through its partners across the continent’s different territories.
In 2015, Celltrion told us: “A two-brand strategy for the same product is not uncommon in the industry. Due to marketing matters, including cultural differences and different distributors in local markets, pharmaceutical companies use multiple brand names catering to local needs.”