Samsung Bioepis - a joint venture between Samsung Biologics and Biogen– submitted Benepali (etanercept) for review by the European Medicines Agency (EMA) in January.
Last week the firms received a positive opinion from the Agency’s Committee for Medicinal Products for Human Use (CHMP), meaning the candidate has been recommended for approval by the European Commission, whose decision is expected next year.
“The positive opinion for Benepali puts us on track to bring the first biosimilar of Enbrel to market in Europe,” Biogen spokesperson Shannon Altimari told Biopharma-Reporter.com. “The CHMP opinion marks the JV’s first regulatory milestone in Europe.”
The JV was formed in 2012 between Korea’s Samsung and Switzerland Biogen and has a number of biosimilars in its pipeline on top of Benepali (formerly known as SB4).
“Samsung Bioepis has filed for SB2 (infliximab – a version of J&J’s Remicade) approval with the EC, the CHMP opinion for that compound is expected 1H2016,” Altimari said.
“Recently, Phase III data for SB5 (adalimumab) was presented at the ACR meeting in San Francisco. The data confirmed a high level of biosimilarity between SB5 and the reference product, [AbbVie’s] Humira.”
Biogen owns the commercialisation rights for Benepali in Europe, Switzerland, and Japan, while Merck & Co. (known as MSD outside North America) will commercialise the biosimilar in all other markets, excluding the US, and is expected to launch the product in Korea before the end of the year.
In the US, Amgen has secured secondary patents intended to keep competition away until at least 2028, though Novartis subsidiary Sandoz is looking to challenge this and submitted its own version of Enbrel to the FDA for review last month.
The biosimilar is made at Biogen’s plant in Hillerød, Denmark, which uses the same people and development processes as its originator products, Altimari explained.
“We have a strong track record of manufacturing and supplying therapies to those who need them most.”