Regulatory Approvals Encouraging for Biosimilar Makers, says Coherus

By Dan Stanton

- Last updated on GMT

Related tags Monoclonal antibodies Etanercept

Regulatory Approvals Encouraging for Biosimilar Makers, says Coherus
Recent regulatory approvals have led to biosimilars being perceived as a lower regulatory risk and more commercially viable, according to Coherus.

Earlier in the summer the European Medicines Agency (EMA) approved the two biosimilar monoclonal antibodies​ pushing the total number of biosimilars available in Europe to 14.

Though the US still awaits its first approval, a number of big players are turning to these ‘copycat’ biologics with the latest development deal inked earlier this week between Coherus Biosciences and Baxter International​.

“The EU’s recent approval of Remsima and Inflectra demonstrates what is achievable from regulatory agencies on biosimilars,”​ Deepa Prasad, a Coherus spokesperson, told “Companies now can clearly see the commercial viability of biosimilar products as regulatory risk is perceived to be less.”

Furthermore, whilst the “EU has led in terms of biosimilar legislation and thought development primarily due to earlier patent expiration timing relative to other territories,”​ Prasad said Coherus expects “rough harmonization between the major regulated countries ultimately.”

Coherus, Partners and Etanercept

“Several of the biosimilar players today are big pharmas and large consortiums pursuing biosimilars as part of their overall product strategy,”​ said Prasad, who added Coherus differed by being “an independent, pure-play biosimilar company solely focused in the arena.

“Our business model comprises a global consortium of partners who are also investors in our company, aligning everyone’s incentives for success.  We believe all of these factors have given confidence to our partners in our ability to take a product from conception to commercialization.”

The deal with Baxter will see Coherus execute the development and manufacturing of a biosimilar of Enbrel (etanercept) - a biologic that treats autoimmune diseases co-marketed by Amgen and Pfizer in North America – with potential expansion to include other biosimilars.

Following development, Baxter will have rights in Europe, Canada, Brazil and other markets, Baxter spokesperson Brian Kyhos told us.

Coherus also has a partnership penned in May 2012​ with Daiichi Sankyo to develop and manufacture biosimilar forms of etanercept and rituximab for the Japanese, Taiwanese and South Korean market, which Prasad confirmed was still ongoing.

Related topics Markets & Regulations Biosimilars

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