Russia approves first ever biosimilar of Serono’s MS drug Rebif

By Dani Bancroft contact

- Last updated on GMT

© Biocad
© Biocad
Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).

The Russian firm has GMP-compliant manufacturing facilities in Moscow, and a second facility close to its headquarters in Saint Petersburg, which is where the active pharmaceutical ingredients for interferon beta-1a are produced.

Roman Ivanov, VP of R&D at Biocad, told us CHO cells are used to produce the interferon beta-1a APIs using 1,000L single-use HyClone bioreactors at the St Petersburg site.

The 2,000m2​ site has a monoclonal antibody capacity of up to 160kg a year, and scale up to meet the market demand for interferon-based products would not be an issue.

“Despite the fact that interferon beta-1a is one of the biggest selling products in Russia, the annual demand for this product can be managed using just several fermentation bioreactors,” ​Ivanov explained.

“It’s nothing compared to the volume of monoclonal antibodies the facility produces,”​ he continued, adding that finishing process of interferon beta-1a takes place at the Moscow facility.

Biocad has a number of biosimilar products on the Russian market, including a version of Roche’s Herceptin (trastuzumab) approved last January​.

EMA guidelines

The Rebif biosimilar was developed in accordance with EMA guidelines.

“Marketing approval [of Biocad’s interferon beta-1a] was based on this one year of data, and we're now continuing administration of the biosimilar to generate additional long-term data,”​ said Ivanov.

Non-clinical development of BIOCAD’s next-in-class humanised anti-CD20 antibody, is also projected to enter clinical development for MS later this year.

“The company is even developing three generics of second generation disease modifying drugs for MS: fingolimod, dimethyl fumarate, teriflunomide,”​ Ivanov added.

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