MAb biosimilar Inflectra launched in CEE region; Approved in Canada

By Dan Stanton

- Last updated on GMT

Related tags: Monoclonal antibodies, Rheumatoid arthritis

MAb biosimilar Inflectra launched in CEE region; Approved in Canada
Inflectra has been launched in Central and Eastern Europe (CEE) and, as the world’s first monoclonal antibody biosimilar drug goes from strength-to-strength, has also been approved by Health Canada.

Inflectra (infliximab) became the first MAb biosimialr product to be approved in an established market last June​ when the European Medicines Agency (EMA) gave the thumbs up to Hospira and Celltrion’s bioequivalent version of Johnson & Johnson’s rheumatoid arthritis drug Remicade.

During a conference call discussing Hospira’s end of year results on Wednesday, CEO Michael Ball said the firm had begun its launch of Inflectra in ten early-launch countries.

Our initial focus will be on rolling out Inflectra in the smaller early-launch countries through 2014, moving to direct sales in the larger markets countries in 2015 as the patents expire in these countries.”

Whilst the patent for Remicade in Western Europe runs until February 2015 – after J&J received a six month extension last year – Hospira’s marketing partner Alvogen announced this week it was launching the biosimilar throughout the CEE region.

“This product represents a major milestone for our biosimilar portfolio, which has been making great progress since its launch in partnership with Hospira in 2011,”​ said EVP of Alvogen in the CEE region, Petar Vazharov. “Biosimilars offer a huge opportunity for our business in Eastern Europe and with Inflectra we demonstrate the continued growth we are achieving in this important portfolio.”

Alvogen recently announced it was expanding its own biosimilar programme​, with a specific focus on the CEE market, by investing $250m (€182m) in a new Icelandic facility dedicated to manufacturing monoclonal antibodies.

Health Canada

The CEE launch comes just weeks after Inflectra received further regulatory recognition.

“Last month we received approval from Health Canada for Inflectra, our biosimilar infliximab for four indications,”​ Ball announced on the call. “This is the first biosimilar monoclonal antibody to be approved in Canada.”

A Notice of Compliance (NOC) with no conditions was issued to Hospira's Korean partner Celltrion on January 15, and Inflectra becomes the third biosimilar product to be approved in the country after Sandoz’s growth hormone, Omnitrope, became the first in 2009.

Hospira has positioned itself as one of the top players in the biosimilar market with an R&D pipeline of eleven molecules  it estimates to have a local market value of $40bn​.

According to CFO Thomas Werner, the firm has so far eclipsed the $100m mark for biosimilar sales but when asked during the call was unable to break this figure down.

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